Background Cognitive therapy and behavioural activation are both widely applied and effective psychotherapies for depression, but it is unclear which works best for whom. Individual participant data (IPD) meta-analysis allows for examining moderators at the participant level and can provide more precise effect estimates than conventional meta-analysis, which is based on study-level data. Aims This article describes the protocol for a systematic review and IPD meta-analysis that aims to compare the efficacy of cognitive therapy and behavioural activation for adults with depression, and to explore moderators of treatment effect. (PROSPERO: CRD42022341602) Method Systematic literature searches will be conducted in PubMed, PsycINFO, EMBASE and the Cochrane Library, to identify randomised clinical trials comparing cognitive therapy and behavioural activation for adult acute-phase depression. Investigators of these trials will be invited to share their participant-level data. One-stage IPD meta-analyses will be conducted with mixed-effects models to assess treatment effects and to examine various available demographic, clinical and psychological participant characteristics as potential moderators. The primary outcome measure will be depressive symptom level at treatment completion. Secondary outcomes will include post-treatment anxiety, interpersonal functioning and quality of life, as well as follow-up outcomes. Conclusions to the best of our knowledge, this will be the first IPD meta-analysis concerning cognitive therapy versus behavioural activation for adult depression. This study has the potential to enhance our knowledge of depression treatment by using state-of-the-art statistical techniques to compare the efficacy of two widely used psychotherapies, and by shedding more light on which of these treatments might work best for whom.

A secondary analysis of the COBRA randomized controlled trial was conducted to examine how well Cognitive Behavioural Therapy (CBT) and Behavioural Activation (BA) repair anhedonia. Patients with current major depressive disorder (N = 440) were randomized to receive BA or CBT, and anhedonia and depression outcomes were measured after acute treatment (six months) and at two further follow up intervals (12 and 18 months). Anhedonia was assessed using the Snaith Hamilton Pleasure Scale (SHAPS; a measure of consummatory pleasure). Both CBT and BA led to significant improvements in anhedonia during acute treatment, with no significant difference between treatments. Participants remained above healthy population averages of anhedonia at six months, and there was no further significant improvement in anhedonia at 12-month or 18-month follow up. Greater baseline anhedonia severity predicted reduced repair of depression symptoms and fewer depression-free days across the follow-up period following both BA and CBT. The extent of anhedonia repair was less marked than the extent of depression repair across both treatment arms. These findings demonstrate that CBT and BA are similarly and only partially effective in treating anhedonia. Therefore, both therapies should be further refined or novel treatments should be developed in order better to treat anhedonia.

Aim: This systematic review identifies, appraises and synthesizes the evidence on the provision of fundamental nursing care to hospitalized patients with a highly infectious virus and the effectiveness of adaptations to overcome barriers to care. Design: Systematic review. Data Sources: in July 2020, we searched Medline, PsycINFO (OvidSP), CINAHL (EBSCOhost), BNI (ProQuest), WHO COVID-19 Database (https://search.bvsalud.org/) MedRxiv (https://www.medrxiv.org/), bioRxiv (https://www.biorxiv.org/) and also Google Scholar, TRIP database and NICE Evidence, forwards citation searching and reference checking of included papers, from 2016 onwards. Review Methods: We included quantitative and qualitative research reporting (i) the views, perceptions and experiences of patients who have received fundamental nursing care whilst in hospital with COVID-19, MERS, SARS, H1N1 or EVD or (ii) the views, perceptions and experiences of professional nurses and non-professionally registered care workers who have provided that care. We included review articles, commentaries, protocols and guidance documents. One reviewer performed data extraction and quality appraisal and was checked by another person. Results: of 3086 references, we included 64 articles; 19 empirical research and 45 review articles, commentaries, protocols and guidance documents spanning five pandemics. Four main themes (and 11 sub-themes) were identified. Barriers to delivering fundamental care were wearing personal protective equipment, adequate staffing, infection control procedures and emotional challenges of care. These barriers were addressed by multiple adaptations to communication, organization of care, staff support and leadership. Conclusion: to prepare for continuation of the COVID-19 pandemic and future pandemics, evaluative studies of adaptations to fundamental healthcare delivery must be prioritized to enable evidence-based care to be provided in future. Impact: Our review identifies the barriers nurses experience in providing fundamental care during a pandemic, highlights potential adaptations that address barriers and ensure positive healthcare experiences and draws attention to the need for evaluative research on fundamental care practices during pandemics.

IMPORTANCE: Socioeconomic factors are associated with the prevalence of depression, but their associations with prognosis are unknown. Understanding this association would aid in the clinical management of depression. OBJECTIVE: to determine whether employment status, financial strain, housing status, and educational attainment inform prognosis for adults treated for depression in primary care, independent of treatment and after accounting for clinical prognostic factors. DATA SOURCES: the Embase, International Pharmaceutical Abstracts, MEDLINE, PsycINFO, and Cochrane (CENTRAL) databases were searched from database inception to October 8, 2021. STUDY SELECTION: Inclusion criteria were as follows: randomized clinical trials that used the Revised Clinical Interview Schedule (CIS-R; the most common comprehensive screening and diagnostic measure of depressive and anxiety symptoms in primary care randomized clinical trials), measured socioeconomic factors at baseline, and sampled patients with unipolar depression who sought treatment for depression from general physicians/practitioners or who scored 12 or more points on the CIS-R. Exclusion criteria included patients with depression secondary to a personality or psychotic disorder or neurologic condition, studies of bipolar or psychotic depression, studies that included children or adolescents, and feasibility studies. Studies were independently assessed against inclusion and exclusion criteria by 2 reviewers. DATA EXTRACTION AND SYNTHESIS: Data were extracted and cleaned by data managers for each included study, further cleaned by multiple reviewers, and cross-checked by study chief investigators. Risk of bias and quality were assessed using the Quality in Prognosis Studies (QUIPS) and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) tools, respectively. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses-Individual Participant Data (PRISMA-IPD) reporting guidelines. MAIN OUTCOMES AND MEASURES: Depressive symptoms at 3 to 4 months after baseline. RESULTS: This systematic review and individual patient data meta-analysis identified 9 eligible studies that provided individual patient data for 4864 patients (mean [SD] age, 42.5 (14.0) years; 3279 women [67.4%]). The 2-stage random-effects meta-analysis end point depressive symptom scale scores were 28% (95% CI, 20%-36%) higher for unemployed patients than for employed patients and 18% (95% CI, 6%-30%) lower for patients who were homeowners than for patients living with family or friends, in hostels, or homeless, which were equivalent to 4.2 points (95% CI, 3.6-6.2 points) and 2.9 points (95% CI, 1.1-4.9 points) on the Beck Depression Inventory II, respectively. Financial strain and educational attainment were associated with prognosis independent of treatment, but unlike employment and housing status, there was little evidence of associations after adjusting for clinical prognostic factors. CONCLUSIONS AND RELEVANCE: Results of this systematic review and meta-analysis revealed that unemployment was associated with a poor prognosis whereas home ownership was associated with improved prognosis. These differences were clinically important and independent of the type of treatment received. Interventions that address employment or housing difficulties could improve outcomes for patients with depression.

BACKGROUND: Subgrouping methods have the potential to support treatment decision making for patients with depression. Such approaches have not been used to study the continued course of depression or likelihood of relapse following treatment. METHOD: Data from individual participants of seven randomised controlled trials were analysed. Latent profile analysis was used to identify subgroups based on baseline characteristics. Associations between profiles and odds of both continued chronic depression and relapse up to one year post-treatment were explored. Differences in outcomes were investigated within profiles for those treated with antidepressants, psychological therapy, and usual care. RESULTS: Seven profiles were identified; profiles with higher symptom severity and long durations of both anxiety and depression at baseline were at higher risk of relapse and of chronic depression. Members of profile five (likely long durations of depression and anxiety, moderately-severe symptoms, and past antidepressant use) appeared to have better outcomes with psychological therapies: antidepressants vs. psychological therapies (OR (95% CI) for relapse = 2.92 (1.24-6.87), chronic course = 2.27 (1.27-4.06)) and usual care vs. psychological therapies (relapse = 2.51 (1.16-5.40), chronic course = 1.98 (1.16-3.37)). CONCLUSIONS: Profiles at greater risk of poor outcomes could benefit from more intensive treatment and frequent monitoring. Patients in profile five may benefit more from psychological therapies than other treatments.

IntroductionPatient experience of nursing care is correlated with safety, clinical effectiveness, care quality, treatment outcomes and service use. Effective nursing care includes actions to develop nurse–patient relationships and deliver physical and psychosocial care to patients. The high risk of transmission of the SARS-CoV-2 virus compromises nursing care. No evidence-based nursing guidelines exist for patients infected with SARS-CoV-2, leading to potential variations in patient experience, outcomes, quality and costs.Methods and analysiswe aim to recruit 840 in-patient participants treated for infection with the SARS-CoV-2 virus from 14 UK hospitals, to a cluster randomised controlled trial, with embedded process and economic evaluations, of care as usual and a fundamental nursing care protocol addressing specific areas of physical, relational and psychosocial nursing care where potential variation may occur, compared with care as usual. Our coprimary outcomes are patient-reported experience (Quality from the Patients’ Perspective; Relational Aspects of Care Questionnaire); secondary outcomes include care quality (pressure injuries, falls, medication errors); functional ability (Barthell Index); treatment outcomes (WHO Clinical Progression Scale); depression Patient Health Questionnaire-2 (PHQ-2), anxiety General Anxiety Disorder-2 (GAD-2), health utility (EQ5D) and nurse-reported outcomes (Measure of Moral Distress for Health Care Professionals). For our primary analysis, we will use a standard generalised linear mixed-effect model adjusting for ethnicity of the patient sample and research intensity at cluster level. We will also undertake a planned subgroup analysis to compare the impact of patient-level ethnicity on our primary and secondary outcomes and will undertake process and economic evaluations.Ethics and disseminationResearch governance and ethical approvals are from the UK National Health Service Health Research Authority Research Ethics Service. Dissemination will be open access through peer-reviewed scientific journals, study website, press and online media, including free online training materials on the Open University’s FutureLearn web platform.Trial registration numberISRCTN13177364; Pre-results.

UNLABELLED: to assess whether CC is more effective at reducing suicidal ideation in people with depression compared with usual care, and whether study and patient factors moderate treatment effects. METHOD: We searched Medline, Embase, PubMed, PsycINFO, CINAHL, CENTRAL from inception to March 2020 for Randomised Controlled Trials (RCTs) that compared the effectiveness of CC with usual care in depressed adults, and reported changes in suicidal ideation at 4 to 6 months post-randomisation. Mixed-effects models accounted for clustering of participants within trials and heterogeneity across trials. This study is registered with PROSPERO, CRD42020201747. RESULTS: We extracted data from 28 RCTs (11,165 patients) of 83 eligible studies. We observed a small significant clinical improvement of CC on suicidal ideation, compared with usual care (SMD, -0.11 [95%CI, -0.15 to -0.08]; I2, 0·47% [95%CI 0.04% to 4.90%]). CC interventions with a recognised psychological treatment were associated with small reductions in suicidal ideation (SMD, -0.15 [95%CI -0.19 to -0.11]). CC was more effective for reducing suicidal ideation among patients aged over 65 years (SMD, - 0.18 [95%CI -0.25 to -0.11]). CONCLUSION: Primary care based CC with an embedded psychological intervention is the most effective CC framework for reducing suicidal ideation and older patients may benefit the most.

AIM: to explore nurses' and physicians' experiences with diabetes consultations in general and the use of dialogue tools in the Diabetes Patient-Related Outcome Measures (DiaPROM) pilot trial. METHODS: We used a qualitative explorative design by conducting semi-structured in-depth interviews with five nurses and nine physicians engaged in the DiaPROM pilot trial. The pilot trial aimed to test an intervention utilizing the patient-reported Problem Areas in Diabetes (PAID) scale and person-centred communication skills as dialogue tools in clinical consultations with adults with type 1 diabetes. We used thematic analysis to analyse the data. RESULTS: We generated three themes (each including two subthemes) from the analysis of participants' experiences: (1) 'Conflicting demands and priorities' (subthemes: 'Balancing guideline recommendations with patients' main concerns' and 'Experiencing that patients need more support to disclose their emotional concerns'); (2) 'Insights about using dialogue tools' (subthemes: 'The benefits and challenges of using the PAID as a dialogue tool' and 'Communication techniques are helpful'); and (3) 'Facilitating new interventions is challenging' (subthemes: 'Unclear roles and responsibilities in the multidisciplinary teamwork' and 'The capacity sets the limit, not the willingness'). CONCLUSIONS: Our findings indicate that the physicians and nurses experienced substantial challenges related to time and resources in the use of dialogue tools to support people's emotional concerns in clinical diabetes consultations. Thus, there is a need for healthcare organizations to adjust priorities to focus on the emotional burden of diabetes if the multidisciplinary diabetes teams are to successfully integrate psychosocial support into routine diabetes care.

AIMS: to determine whether age, gender and marital status are associated with prognosis for adults with depression who sought treatment in primary care. METHODS: Medline, Embase, PsycINFO and Cochrane Central were searched from inception to 1st December 2020 for randomised controlled trials (RCTs) of adults seeking treatment for depression from their general practitioners, that used the Revised Clinical Interview Schedule so that there was uniformity in the measurement of clinical prognostic factors, and that reported on age, gender and marital status. Individual participant data were gathered from all nine eligible RCTs (N = 4864). Two-stage random-effects meta-analyses were conducted to ascertain the independent association between: (i) age, (ii) gender and (iii) marital status, and depressive symptoms at 3-4, 6-8, and 9-12 months post-baseline and remission at 3-4 months. Risk of bias was evaluated using QUIPS and quality was assessed using GRADE. PROSPERO registration: CRD42019129512. Pre-registered protocol https://osf.io/e5zup/. RESULTS: There was no evidence of an association between age and prognosis before or after adjusting for depressive 'disorder characteristics' that are associated with prognosis (symptom severity, durations of depression and anxiety, comorbid panic disorderand a history of antidepressant treatment). Difference in mean depressive symptom score at 3-4 months post-baseline per-5-year increase in age = 0(95% CI: -0.02 to 0.02). There was no evidence for a difference in prognoses for men and women at 3-4 months or 9-12 months post-baseline, but men had worse prognoses at 6-8 months (percentage difference in depressive symptoms for men compared to women: 15.08% (95% CI: 4.82 to 26.35)). However, this was largely driven by a single study that contributed data at 6-8 months and not the other time points. Further, there was little evidence for an association after adjusting for depressive 'disorder characteristics' and employment status (12.23% (-1.69 to 28.12)). Participants that were either single (percentage difference in depressive symptoms for single participants: 9.25% (95% CI: 2.78 to 16.13) or no longer married (8.02% (95% CI: 1.31 to 15.18)) had worse prognoses than those that were married, even after adjusting for depressive 'disorder characteristics' and all available confounders. CONCLUSION: Clinicians and researchers will continue to routinely record age and gender, but despite their importance for incidence and prevalence of depression, they appear to offer little information regarding prognosis. Patients that are single or no longer married may be expected to have slightly worse prognoses than those that are married. Ensuring this is recorded routinely alongside depressive 'disorder characteristics' in clinic may be important.

Aims: Self-care in heart failure (HF) is generally sub-optimal and impacts morbidity and mortality. To describe self-care prevalence and explore its relationships with symptom experience, patient needs, and health-care utilization in a Swiss hospital providing regional secondary care. Methods and results: Cross-sectional study, convenience sample of individuals with HF from four campuses of one regional Swiss hospital. Self-care was assessed via the Self-Care of Heart Failure Index (SCHFI) and the European Heart Failure Self-care Behaviour Scale (EHFScBS), symptom experience via the M.D. Anderson Symptom Inventory-HF (MDASI-HF) and needs via the Heart Failure Needs Assessment Questionnaire (HFNAQ). Healthcare utilization reflected the preceding year's hospitalization incidence. A cut-off level of ≥70% indicated adequate self-care. We analysed SCHFI, EHFScBS, MDASI-HF and HFNAQ scores' relationships with hospitalizations using Spearman's rho correlation; no prior hypotheses were stated. Sample of 310 individuals with HF (37.4% female; mean age 76.8; 55% NYHA III). Adequate self-care maintenance, management, and confidence were reported by 24%, 10%, and 61%. respectively. The sample's mean number of experienced symptoms was 12.8 (SD 4.0) and 14.0 (SD 5.8) for needs. Over the previous year, 269 hospitalizations had occurred (median: 0, IQR 1). Hospitalizations positively correlated with self-care; symptom experience with needs. Neither symptom experience nor needs correlated with hospitalizations. Conclusion: the findings indicated low self-care levels and suggest a need for increased support to maintain physiological stability, manage symptoms and prevent hospitalizations. This study is the first of its kind in Switzerland and among few studies worldwide to report on self-care, symptom experience, needs, and health-care utilization. Interventional studies are warranted considering baseline self-care capabilities, symptoms, and needs of individuals with HF.

AbstractBackgroundThis study aimed to investigate general factors associated with prognosis regardless of the type of treatment received, for adults with depression in primary care.MethodsWe searched Medline, Embase, PsycINFO and Cochrane Central (inception to 12/01/2020) for RCTs that included the most commonly used comprehensive measure of depressive and anxiety disorder symptoms and diagnoses, in primary care depression RCTs (the Revised Clinical Interview Schedule: CIS-R). Two-stage random-effects meta-analyses were conducted.ResultsTwelve (n = 6024) of thirteen eligible studies (n = 6175) provided individual patient data. There was a 31% (95%CI: 25 to 37) difference in depressive symptoms at 3–4 months per standard deviation increase in baseline depressive symptoms. Four additional factors: the duration of anxiety; duration of depression; comorbid panic disorder; and a history of antidepressant treatment were also independently associated with poorer prognosis. There was evidence that the difference in prognosis when these factors were combined could be of clinical importance. Adding these variables improved the amount of variance explained in 3–4 month depressive symptoms from 16% using depressive symptom severity alone to 27%. Risk of bias (assessed with QUIPS) was low in all studies and quality (assessed with GRADE) was high. Sensitivity analyses did not alter our conclusions.ConclusionsWhen adults seek treatment for depression clinicians should routinely assess for the duration of anxiety, duration of depression, comorbid panic disorder, and a history of antidepressant treatment alongside depressive symptom severity. This could provide clinicians and patients with useful and desired information to elucidate prognosis and aid the clinical management of depression.

To pilot test the proposed DiaPROM trial components and address uncertainties associated with conducting a full-scale randomised controlled trial (RCT) to evaluate whether such a trial is feasible. Two-arm pilot RCT. Adults aged ≥18–39 years, with minimum 1 year type 1 diabetes duration, attending outpatient follow-up. Exclusion criteria were pregnancy, severe cognitive, somatic or psychiatric conditions and impaired vision. All participants completed electronic Patient-Reported Outcome Measures (PROMs) prior to the annual diabetes consultation. Using computer-generated block-randomisation without blinding, we assigned participants in a 1:1 ratio stratified by sex to receive standard care or an intervention. Physicians reviewed diabetes distress scores (Problem Areas in Diabetes scale) and referred individuals with scores ≥30 or single item(s) ≥3 to minimum two diabetes nurse consultations where reported problems were reviewed and discussed. Recruitment and retention rates; participants perceptions about intervention components. Variance and estimated between-group differences in follow-up scores (Diabetes Distress Scale(DDS),WHO 5-Well-being Index,Perceived Competence for Diabetes Scaleandglycaemic control) and DDS correlation with baseline scores, to assist sample size calculations. We randomised 80 participants to the control or intervention arm (one participant was later excluded). 23/39 intervention arm participants qualified for additional consultations and 17 attended. 67/79 attended the 12-month follow-up (15.2% attrition); 5/17 referred to additional consultations were lost to follow-up (29.4% attrition). Participants reported PROMs as relevant (84.6%) and acceptable (97.4%) but rated the usefulness of consultations as moderate to low. Baseline mean±SD DDS score was 2.1±0.69; DDS SD was 0.71 (95% CI: 0.60 to 0.86) at follow-up; correlation between baseline and follow-up DDS scores was 0.8 (95% CI: 0.7 to 0.9). The pilot trial revealed need for intervention modifications ahead of a full-scale trial to evaluate use of PROMs in diabetes consultations. Specifically, participant acceptability and intervention implementation need further investigation.

BACKGROUND: Behavioural activation is a brief psychotherapeutic approach that seeks to change the way a person interacts with their environment. Behavioural activation is increasingly receiving attention as a potentially cost-effective intervention for depression, which may require less resources and may be easier to deliver and implement than other types of psychotherapy. OBJECTIVES: to examine the effects of behavioural activation compared with other psychological therapies for depression in adults. To examine the effects of behavioural activation compared with medication for depression in adults. To examine the effects of behavioural activation compared with treatment as usual/waiting list/placebo no treatment for depression in adults. SEARCH METHODS: We searched CCMD-CTR (all available years), CENTRAL (current issue), Ovid MEDLINE (1946 onwards), Ovid EMBASE (1980 onwards), and Ovid PsycINFO (1806 onwards) on the 17 January 2020 to identify randomised controlled trials (RCTs) of 'behavioural activation', or the main elements of behavioural activation for depression in participants with clinically diagnosed depression or subthreshold depression. We did not apply any restrictions on date, language or publication status to the searches. We searched international trials registries via the World Health Organization's trials portal (ICTRP) and ClinicalTrials.gov to identify unpublished or ongoing trials. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of behavioural activation for the treatment of depression or symptoms of depression in adults aged 18 or over. We excluded RCTs conducted in inpatient settings and with trial participants selected because of a physical comorbidity. Studies were included regardless of reported outcomes. DATA COLLECTION AND ANALYSIS: Two review authors independently screened all titles/abstracts and full-text manuscripts for inclusion. Data extraction and 'Risk of bias' assessments were also performed by two review authors in duplicate. Where necessary, we contacted study authors for more information. MAIN RESULTS: Fifty-three studies with 5495 participants were included; 51 parallel group RCTs and two cluster-RCTs. We found moderate-certainty evidence that behavioural activation had greater short-term efficacy than treatment as usual (risk ratio (RR) 1.40, 95% confidence interval (CI) 1.10 to 1.78; 7 RCTs, 1533 participants), although this difference was no longer evident in sensitivity analyses using a worst-case or intention-to-treat scenario. Compared with waiting list, behavioural activation may be more effective, but there were fewer data in this comparison and evidence was of low certainty (RR 2.14, 95% CI 0.90 to 5.09; 1 RCT, 26 participants). No evidence on treatment efficacy was available for behavioural activation versus placebo and behavioural activation versus no treatment. We found moderate-certainty evidence suggesting no evidence of a difference in short-term treatment efficacy between behavioural activation and CBT (RR 0.99, 95% CI 0.92 to 1.07; 5 RCTs, 601 participants). Fewer data were available for other comparators. No evidence of a difference in short term-efficacy was found between behavioural activation and third-wave CBT (RR 1.10, 95% CI 0.91 to 1.33; 2 RCTs, 98 participants; low certainty), and psychodynamic therapy (RR 1.21, 95% CI 0.74 to 1.99; 1 RCT,60 participants; very low certainty). Behavioural activation was more effective than humanistic therapy (RR 1.84, 95% CI 1.15 to 2.95; 2 RCTs, 46 participants; low certainty) and medication (RR 1.77, 95% CI 1.14 to 2.76; 1 RCT; 141 participants; moderate certainty), but both of these results were based on a small number of trials and participants. No evidence on treatment efficacy was available for comparisons between behavioural activation versus interpersonal, cognitive analytic, and integrative therapies. There was moderate-certainty evidence that behavioural activation might have lower treatment acceptability (based on dropout rate) than treatment as usual in the short term, although the data did not confirm a difference and results lacked precision (RR 1.64, 95% CI 0.81 to 3.31; 14 RCTs, 2518 participants). Moderate-certainty evidence did not suggest any difference in short-term acceptability between behavioural activation and waiting list (RR 1.17, 95% CI 0.70 to 1.93; 8 RCTs. 359 participants), no treatment (RR 0.97, 95% CI 0.45 to 2.09; 3 RCTs, 187 participants), medication (RR 0.52, 95% CI 0.23 to 1.16; 2 RCTs, 243 participants), or placebo (RR 0.72, 95% CI 0.31 to 1.67; 1 RCT; 96 participants; low-certainty evidence). No evidence on treatment acceptability was available comparing behavioural activation versus psychodynamic therapy. Low-certainty evidence did not show a difference in short-term treatment acceptability (dropout rate) between behavioural activation and CBT (RR 1.03, 95% CI 0.85 to 1.25; 12 RCTs, 1195 participants), third-wave CBT (RR 0.84, 95% CI 0.33 to 2.10; 3 RCTs, 147 participants); humanistic therapy (RR 1.06, 95% CI 0.20 to 5.55; 2 RCTs, 96 participants) (very low certainty), and interpersonal, cognitive analytic, and integrative therapy (RR 0.84, 95% CI 0.32 to 2.20; 4 RCTs, 123 participants). Results from medium- and long-term primary outcomes, secondary outcomes, subgroup analyses, and sensitivity analyses are summarised in the text. AUTHORS' CONCLUSIONS: This systematic review suggests that behavioural activation may be more effective than humanistic therapy, medication, and treatment as usual, and that it may be no less effective than CBT, psychodynamic therapy, or being placed on a waiting list. However, our confidence in these findings is limited due to concerns about the certainty of the evidence. We found no evidence of a difference in short-term treatment acceptability (based on dropouts) between behavioural activation and most comparison groups (CBT, humanistic therapy, waiting list, placebo, medication, no treatment or treatment as usual). Again, our confidence in all these findings is limited due to concerns about the certainty of the evidence. No data were available about the efficacy of behaioural activation compared with placebo, or about treatment acceptability comparing behavioural activation and psychodynamic therapy, interpersonal, cognitive analytic and integrative therapies. The evidence could be strengthened by better reporting and better quality RCTs of behavioural activation and by assessing working mechanisms of behavioural activation.

AIMS AND OBJECTIVES: to systematically identify, appraise and synthesise patients', residents' and nurses' experiences of fundamental nursing care for nutrition, elimination, mobility and hygiene. BACKGROUND: the evidence base for effective nursing behaviours to assist people with their fundamental care needs is sparse, hampering the development of effective interventions. Synthesising data on patients' and nurses' experiences of fundamentals of nursing care could contribute to the development of such an intervention. METHODS: Systematic review and synthesis of qualitative data from qualitative studies on patients' and nurses' experiences of fundamental nursing care behaviours addressing peoples' nutrition, elimination, mobility and hygiene needs. We appraised study quality and relevance and used a narrative approach to data synthesis, fulfilling PRISMA criteria (Appendix S2). RESULTS: We identified 22,374 papers, and 47 met our inclusion criteria. Most papers were of low quality. Sixteen papers met our quality and relevance criteria and were included for synthesis. Papers were about nutrition (2) elimination (2), mobility (5), hygiene (5) and multiple care areas (2). We found nurses and patients report that fundamental nursing care practices involve strong leadership, collaborative partnerships with patients and cohesive organisational practices aligned to nursing care objectives and actions. CONCLUSIONS: to improve fundamental care and interventions suitable for testing may require attention to leadership, patient-nurse relationships and organisational coherence plus the fundamentals of care nursing interventions themselves. RELEVANCE TO CLINICAL PRACTICE: More rigorous mixed methods research about fundamental nursing care is needed to inform nursing practice and improve patient's experience. Nursing interventions should include effective nurse leadership and nurse-patient collaboration and a focus on fundamental care by the host organisation.

BACKGROUND: Current quantitative methods for personalising psychotherapies for depression are unlikely to be able to inform clinical decision-making for hundreds of years. Novel alternative methods to generate hypotheses for prospective testing are therefore required, and we showcase mixed methods as one such approach. By exploring patients' perspectives in depth, and integrating qualitative and quantitative data at the level of the individual, we may identify new potential psychosocial predictors of psychotherapy outcomes, potentially informing the personalisation of depression treatment in a shorter timeframe. Using Morita therapy (a Japanese psychotherapy) as an exemplar, we thus explored how Morita therapy recipients' views on treatment acceptability explain their adherence and response to treatment. METHODS: the Morita trial incorporated a pilot randomised controlled trial of Morita therapy versus treatment as usual for depression, and post-treatment qualitative interviews. We recruited trial participants from general practice record searches in Devon, UK, and purposively sampled data from 16 participants for our mixed methods analysis. We developed typologies of participants' views from our qualitative themes, and integrated these with quantitative data on number of sessions attended and whether participants responded to treatment in a joint typologies and statistics display. We enriched our analysis using participant vignettes to demonstrate each typology. RESULTS: We demonstrated that (1) participants who could identify with the principles of Morita therapy typically responded to treatment, regardless of how many sessions they attended, whilst those whose orientation towards treatment was incompatible with Morita therapy did not respond to treatment, again regardless of treatment adherence and (2) participants whose personal circumstances impeded their opportunity to engage in Morita therapy attended the fewest sessions, though still benefitted from treatment if the principles resonated with them. CONCLUSIONS: We identified new potential relationships between "orientation" and outcomes, and "opportunity" and adherence, which could not have been identified using existing non-integrative methods. This mixed methods approach warrants replication in future trials and with other psychotherapies to generate hypotheses, based on typologies (or profiles) of patients for whom a treatment is more or less likely to be suitable, to be tested in prospective trials. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN17544090. Registered on 23 July 2015.

BACKGROUND: Relapse (the re-emergence of depression symptoms before full recovery) is common in depression and relapse prevention strategies are not well researched in primary care settings. Collaborative care is effective for treating acute phase depression but little is known about the use of relapse prevention strategies in collaborative care. We undertook a systematic review to identify and characterise relapse prevention strategies in the context of collaborative care. METHODS: We searched for Randomised Controlled Trials (RCTs) of collaborative care for depression. In addition to published material, we obtained provider and patient manuals from authors to provide more detail on intervention content. We reported the extent to which collaborative care interventions addressed four relapse prevention components. RESULTS: 93 RCTs were identified. 31 included a formal relapse prevention plan; 42 had proactive monitoring and follow-up after the acute phase; 39 reported strategies for optimising sustained medication adherence; and 20 of the trials reported psychological or psycho-educational treatments persisting beyond the acute phase or focussing on long-term health/relapse prevention. 30 (32.3%) did not report relapse prevention approaches. LIMITATIONS: We did not receive trial materials for approximately half of the trials, which limited our ability to identify relevant features of intervention content. CONCLUSION: Relapse is a significant risk amongst people treated for depression and interventions are needed that specifically address and minimise this risk. Given the advantages of collaborative care as a delivery system for depression care, there is scope for more consistency and increased effort to implement and evaluate relapse prevention strategies.

Morita Therapy is a Japanese psychotherapy which contrasts with established Western approaches in teaching, through behavioural experience, that symptoms are part of the natural ecology of human experience. Morita Therapy has received increasing international interest over the decades, and the first randomized controlled trial of Morita Therapy to be published outside of China has recently demonstrated the promise of the approach in treating Western patients. To respond to the resulting interest in Morita Therapy from patients and practitioners, and facilitate further Morita Therapy research, it is necessary to provide the detailed explanation of Morita Therapy which is currently rare in the West. In this article, we fill this gap with a thorough description of Morita Therapy in terms of the key principles, objectives and processes of the approach; its basis in Eastern philosophy and naturalism; its sociohistorical context and development over a wide range of formats, patient conditions, and countries. To enable Western practitioners to appreciate and capitalize on the potential value of Morita Therapy as a distinct alternative for patients, we illustrate the approach’s unique method and objective compared to Western psychotherapies, and provide recommendations for practitioners applying Morita Therapy across cultures.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: 1. To examine the effects of behavioural activation compared to all other psychological therapies for acute depression in adults. 2. To examine the effects of behavioural activation compared to all medication for acute depression in adults. 3. To examine the effects of behavioural activation compared to treatment as usual/ waiting list/ attention placebo/ psychological placebo control conditions for acute depression in adults.

BACKGROUND: Living with type 1 diabetes (T1D) is demanding, and emotional problems may impair ability for diabetes self-management. Thus, diabetes guidelines recommend regular assessment of such problems. Using patient-reported outcome measures (PROMs) to assess diabetes-related distress and psychological well-being is considered useful. It has been proposed that future work should examine the use of PROMs to support the care of individual patients and improve the quality of health services. To our knowledge, the use of PROMs has not been systematically evaluated in diabetes care services in Norway. Electronically captured PROMs can be directly incorporated into electronic patient records. Thus, the study's overall aim was to examine the feasibility and acceptability of capturing PROMs electronically on a touchscreen computer in clinical diabetes practice. METHODS: Adults with T1D age ≥ 40 years completed PROMs on a touchscreen computer at Haukeland University Hospital's diabetes outpatient clinic. We included 46 items related to diabetes-related distress, self-perceived diabetes competence, awareness of hypoglycaemia, occurrence of hyperglycaemia, hypoglycaemia and fluctuating glucose levels, routines for glucose monitoring, general well-being and health-related quality of life. Participants subsequently completed a paper-based questionnaire regarding comprehension and relevance of the PROMs, acceptance of the number of items and willingness to complete electronic PROMs annually. We wrote field notes in the outpatient clinic based on observations and comments from the invited participants. RESULTS: During spring 2017, 69 participants (50.7% men), age 40 to 74 years, were recruited. Generally, the touchscreen computer functioned well technically. Median time spent completing the PROMs was 8 min 19 s. Twenty-nine (42.0%) participants completed the PROMs without missing items, with an 81.4% average instrument completion rate. Participants reported that the PROMs were comprehensible (n = 62) and relevant (n = 46) to a large or very large degree, with an acceptable number of items (n = 51). Moreover, 54 were willing to complete PROMs annually. Participants commented that the focus on living with diabetes was valued. CONCLUSIONS: Capturing PROMs on a touchscreen computer in an outpatient clinic was technically and practically feasible. The participants found the PROMs to be relevant and acceptable with a manageable number of items, and reported willingness to complete PROMs annually.

BACKGROUND: the health service delivery framework collaborative care is an effective intervention for depression. However, uncertainties remain about how to optimise its delivery at scale. Structured case management is a core component of collaborative care; its delivery via the telephone may improve access. AIMS: to examine using meta-regression if telephone delivered case management diminishes the clinical effectiveness of collaborative care on depressive symptoms and anti-depressant use relative to face-to-face delivery methods. METHODS: Randomised controlled trials were eligible if they included collaborative care interventions for adults with depression identified using self-report measures or diagnostic interviews and reported depression outcomes. Sociodemographics, intervention characteristics, depressive symptoms, and anti-depressant use were extracted. Random effects univariable and multivariable meta-regression analyses were used to examine the moderating effect of telephone delivered case-management on outcomes. RESULTS: Ninety-four trials were identified comprising of 103 comparisons across 24, 132 participants with depression outcomes and 67 comparisons from 15,367 participants with anti-depressant use outcomes. Telephone delivered case management did not diminish the effects of collaborative care on depressive symptoms (β = -0.01, 95% CI -0.12 to 0.10; p = 0.86). Telephone delivered case management decreased anti-depressant medication use (relative risk 0.76, 95% CI 0.63 to 0.92; p = 0.005); this effect remained when assessed simultaneously alongside other study-level moderators of collaborative care. CONCLUSION: Using remote platforms such as the telephone to deliver case management may be a feasible way to implement collaborative care with no loss of effectiveness on depressive symptoms. However, adherence to anti-depressant medication may decrease when telephone case management is used.

It is common to undertake qualitative research alongside randomised controlled trials (RCTs) when evaluating complex interventions. Researchers tend to analyse these datasets one by one and then consider their findings separately within the discussion section of the final report, rarely integrating quantitative and qualitative data or findings, and missing opportunities to combine data in order to add rigour, enabling thorough and more complete analysis, provide credibility to results, and generate further important insights about the intervention under evaluation. This paper reports on a 2 day expert meeting funded by the United Kingdom Medical Research Council Hubs for Trials Methodology Research with the aims to identify current strengths and weaknesses in the integration of quantitative and qualitative methods in clinical trials, establish the next steps required to provide the trials community with guidance on the integration of mixed methods in RCTs and set-up a network of individuals, groups and organisations willing to collaborate on related methodological activity. We summarise integration techniques and go beyond previous publications by highlighting the potential value of integration using three examples that are specific to RCTs. We suggest that applying mixed methods integration techniques to data or findings from studies involving both RCTs and qualitative research can yield insights that might be useful for understanding variation in outcomes, the mechanism by which interventions have an impact, and identifying ways of tailoring therapy to patient preference and type. Given a general lack of examples and knowledge of these techniques, researchers and funders will need future guidance on how to undertake and appraise them.

OBJECTIVE: the International Learning Collaborative (ILC) is an organisation dedicated to understanding why fundamental care, the care required by all patients regardless of clinical condition, fails to be provided in healthcare systems globally. At its 11th annual meeting in 2019, nursing leaders from 11 countries, together with patient representatives, confirmed that patients' fundamental care needs are still being ignored and nurses are still afraid to 'speak up' when these care failures occur. While the ILC's efforts over the past decade have led to increased recognition of the importance of fundamental care, it is not enough. To generate practical, sustainable solutions, we need to substantially rethink fundamental care and its contribution to patient outcomes and experiences, staff well-being, safety and quality, and the economic viability of healthcare systems. KEY ARGUMENTS: We present five propositions for radically transforming fundamental care delivery:Value: fundamental care must be foundational to all caring activities, systems and institutionsTalk: fundamental care must be explicitly articulated in all caring activities, systems and institutions.Do: fundamental care must be explicitly actioned and evaluated in all caring activities, systems and institutions.Own: fundamental care must be owned by each individual who delivers care, works in a system that is responsible for care or works in an institution whose mission is to deliver care. RESEARCH: fundamental care must undergo systematic and high-quality investigations to generate the evidence needed to inform care practices and shape health systems and education curricula. CONCLUSION: for radical transformation within health systems globally, we must move beyond nursing and ensure all members of the healthcare team-educators, students, consumers, clinicians, leaders, researchers, policy-makers and politicians-value, talk, do, own and research fundamental care. It is only through coordinated, collaborative effort that we will, and must, achieve real change.

Introduction Although diabetes distress is found to be associated with decreased glycaemic control among adults with type 1 diabetes, the psychological and emotional impact of living with the condition is often not recognised and often under-reported in diabetes care. Therefore, regular assessment of diabetes distress is recommended. Assessment of diabetes distress using patient-reported outcome measures (PROMs) in clinical practice has the potential to enhance care for people with diabetes by identifying problems and improving patient-clinician communication. In this study protocol, we describe a pilot randomised controlled trial (RCT) aiming to test the feasibility of all components of an empowerment-based intervention using PROMs as dialogue support in clinical diabetes consultations, and to address the uncertainties associated with running a fully powered evaluation study. Methods and analysis We will undertake a two-Arm pilot RCT of an intervention using the Problem Areas in Diabetes (PAID) scale in clinical diabetes consultations in order to conclude whether a fully powered trial is appropriate and/or feasible. The study will also include qualitative indepth interviews with participants and healthcare providers. Our objectives are to (1) evaluate the recruitment procedures and attrition rates; (2) evaluate the performance of the randomisation procedure; (3) evaluate the participants' mean scores on the outcome measures before and after the intervention; (4) evaluate if the intervention consultations are acceptable and feasible; and (5) explore patients' and healthcare providers' experiences with the use of PAID as dialogue support and empowerment-based communication skills in clinical diabetes consultations. The quantitative data analysis includes descriptive statistics (frequencies, percentages, means, SD and CI). For the qualitative data, we will perform thematic analysis. Ethics and dissemination Ethical approval has been obtained from the Western Norway Regional Committee for Medical and Health Research Ethics (2017/1506/REC west). We will present the findings from the study phases at national and international conferences and submit manuscripts to peer-reviewed journals and popular science journals. Trial registration number NCT03471104; Pre-results.

In this article we ask our profession to consider whether something is rotten at the core of modern nursing. We will use our own experiences as patients, together with published literature, to ask questions of our profession in perpetrating what one of our colleagues recently, and with great embarrassment, referred to as ‘shitty nursing’. Our intention is most certainly not to offend any readers, for this term has been used in literature for more than one hundred years to describe bad situations, including those where events or people's behaviour are of a low standard. Our intention instead, is to challenge ourselves, the profession and you the reader by raising a measured debate which seems at present to be missing within the profession. We examine the potential idea that poor nursing care may not be the exception, but horrifyingly, may be the new normal. We are particularly concerned that patients’ fundamental care needs may be falling into an ever widening gap between assistant and registered nurses. Whilst we acknowledge the potential causes of poor nursing care, causes that are often cited by nurses themselves, we come to the conclusion that a mature profession including clinicians, educators, administrators, researchers and regulators cannot continually blame contextual factors for its failings. A mature profession with an intact contract between itself and society must shoulder some of the responsibility for its own problems. We do suggest a way forward, including a mix of reconciliation, refocus and research, underpinned by what we argue is a much needed dose of professional humility. Readers may take us to task for potentially overstating the problem, ignoring non-nursing drivers, and downplaying other significant factors. You may think that there is much in nursing to glory in. However, we make no apology for presenting our views. Our lived experiences tell us something different. As professional nurses our main aim is to ensure that our adverse experiences as patients are statistical anomalies, and our future encounters with nursing care represent all that we know to be excellent in our profession. We leave you to judge and comment.

BACKGROUND: Around 17% of people attending UK cardiac rehabilitation programmes have depression. Optimising psychological wellbeing is a rehabilitation goal, but provision of psychological care is limited. We developed and piloted an Enhanced Psychological Care (EPC) intervention embedded within cardiac rehabilitation, aiming to test key areas of uncertainty to inform the design of a definitive randomised controlled trial (RCT) and economic evaluation. METHODS: an external pilot randomised controlled trial (RCT) randomised eight cardiac rehabilitation teams (clusters) to either usual care of cardiac rehabilitation provision (UC), or EPC in addition to UC. EPC comprised mental health care coordination and patient-led behavioural activation with nurse support. Adults eligible for cardiac rehabilitation following an acute coronary syndrome and identified with new-onset depressive symptoms during an initial nurse assessment were eligible. Measures were performed at baseline and 5- and 8-month follow-ups and compared between EPC and UC. Team and participant recruitment and retention rates, and participant outcomes (clinical events, depression, anxiety, health-related quality of life, patient experiences, and resource use) were assessed. RESULTS: Eight out of twenty teams were recruited and randomised. of 614 patients screened, 55 were eligible and 29 took part (5%, 95% CI 3 to 7% of those screened), with 15 patient participants cluster randomised to EPC and 14 to UC. Nurse records revealed that 8/15 participants received the maximum number of EPC sessions offered; and 4/15 received no sessions. Seven out of fifteen EPC participants were referred to another NHS psychological service compared to none in UC. We followed up 27/29 participants at 5 months and 17/21 at 8 months. The mean difference (EPC minus UC) in depressive symptoms (Beck Depression Inventory) at follow-up (adjusting for baseline score) was 1.7 (95% CI - 3.8 to 7.3; N = 26) at 5 months and 4.4 (95% CI - 1.4 to 10.2; N = 17) at 8 months. DISCUSSION: While valued by patients and nurses, organisational and workload constraints are significant barriers to EPC implementation. There remains a need to develop and test new models of psychological care within cardiac rehabilitation. Our study offers important data to inform the design of future trials of similar interventions. TRIAL REGISTRATION: ISRCTN34701576. Registered on 29 May 2014. Funding details: UK NIHR HTA Programme (project 12/189/09).

BACKGROUND: Around 19% of people screened by UK cardiac rehabilitation programmes report having moderate or severe symptoms of depression. These individuals are at an increased risk of cardiac mortality and morbidity, reduced quality of life and increased use of health resources compared with their non-depressed counterparts. Maximising psychological health is a goal of cardiac rehabilitation, but psychological care is patchy. OBJECTIVE(S): to examine the feasibility and acceptability of embedding enhanced psychological care (EPC) within cardiac rehabilitation, we tested the feasibility of developing/implementing EPC and documented the key uncertainties associated with undertaking a definitive evaluation. DESIGN: a two-stage multimethods study; a feasibility study and a qualitative evaluation, followed by an external pilot cluster randomised controlled trial (RCT) with a nested qualitative study. SETTING: UK comprehensive cardiac rehabilitation teams. PARTICIPANTS: Adults eligible for cardiac rehabilitation following an acute coronary syndrome with new-onset depressive symptoms on initial nurse assessment. Patients who had received treatment for depression in the preceding 6 months were excluded. INTERVENTIONS: the EPC intervention comprised nurse-led mental health-care co-ordination and behavioural activation within cardiac rehabilitation. The comparator was usual cardiac rehabilitation care. MAIN OUTCOME MEASURES: Measures at baseline, and at the 5- (feasibility and pilot) and 8-month follow-ups (pilot only). Process measures related to cardiac team and patient recruitment, and participant retention. Outcomes included depressive symptoms, cardiac mortality and morbidity, anxiety, health-related quality of life and service resource use. Interviews explored participant and nurses' views and experiences. RESULTS: Between September 2014 and May 2015, five nurses from four teams recruited participants into the feasibility study. of the 203 patients screened, 30 were eligible and nine took part (the target was 20 participants). At interview, participants and nurses gave valuable insights into the EPC intervention design and delivery. Although acceptable, the EPC delivery was challenging for nurses (e.g. the ability to allocate sufficient time within existing workloads) and the intervention was modified accordingly. Between December 2014 and February 2015, 8 out of 20 teams approached agreed to participate in the pilot RCT [five were randomised to the EPC arm and three were randomised to the usual-care (UC) arm]. of the 614 patients screened, 55 were eligible and 29 took part (the target was 43 participants). At baseline, the trial arms were well matched for sex and ethnicity, although the EPC arm participants were younger, from more deprived areas and had higher depression scores than the UC participants. A total of 27 out of 29 participants were followed up at 5 months. Interviews with 18 participants (12 in the EPC arm and six in the UC arm) and seven nurses who delivered EPC identified that both groups acknowledged the importance of receiving psychological support embedded within routine cardiac rehabilitation. For those experiencing/delivering EPC, the intervention was broadly acceptable, albeit challenging to deliver within existing care. LIMITATIONS: Both the feasibility and the pilot studies encountered significant challenges in recruiting patients, which limited the power of the pilot study analyses. CONCLUSIONS: Cardiac rehabilitation nurses can be trained to deliver EPC. Although valued by both patients and nurses, organisational and workload constraints were significant barriers to implementation in participating teams, suggesting that future research may require a modified approach to intervention delivery within current service arrangements. We obtained important data informing definitive research regarding participant recruitment and retention, and optimal methods of data collection. FUTURE RESEARCH: Consideration should be given to the delivery of EPC by dedicated mental health practitioners, working closely with cardiac rehabilitation services. TRIAL REGISTRATION: Current Controlled Trials ISRCTN34701576. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 30. See the NIHR Journals Library website for further project information.

AIMS AND OBJECTIVES: to determine the effects of nursing interventions for people's nutrition, elimination, mobility and hygiene needs. BACKGROUND: Patient experience of health care is sensitive to nursing quality. A refocus on fundamental nursing care is undermined by lack of evidence of effectiveness for interventions in core areas such as elimination, nutrition, mobility and hygiene. DESIGN: Systematic review. METHODS: We searched for and included experimental studies on interventions by professionally qualified and unregistered nurses that addressed participants' nutrition, elimination, mobility and hygiene needs. We extracted data on scope, quality and results of studies followed by descriptive narrative synthesis of included study outcomes using a novel form of harvest plots. RESULTS: We included 149 studies, 35 nutrition, 56 elimination, 16 mobility, 39 hygiene and three addressing two or more areas simultaneously (67 randomised controlled trials, 32 non-randomised controlled trials and 50 uncontrolled trials). Studies into interventions on participant self-management of nutrition (n = 25), oral health (n = 26), catheter care (n = 23) and self-management of elimination (n = 21) were the most prevalent. Most studies focussed their outcomes on observational or physiological measures, with very few collecting patient-reported outcomes, such as quality of life, experience or self-reported symptoms. All but 13 studies were of low quality and at significant risk of bias. The majority of studies did not define primary outcomes, included multiple measures of identical concepts, used inappropriate analyses and did not conform to standard reporting quality criteria. CONCLUSIONS: the current evidence for fundamental nursing care interventions is sparse, of poor quality and unfit to provide evidence-based guidance to practising nurses. RELEVANCE TO CLINICAL PRACTICE: Researchers in nursing internationally should now undertake a programme of work to produce evidence for clinical practice in the fundamentals of care that is reliable, replicable and robust.

Aims and MethodA retrospective survey to explore how consultant psychiatrists, senior house officers and community psychiatric nurses prioritised referrals to four sectorised community mental health teams.ResultsReferral outcomes appeared to be comparable for patients with psychoses, sub-threshold mental health problems and personality disorders. However, differences in the outcomes were apparent for patients with a primary diagnosis of drug/alcohol misuse, as well as for patients with affective disorders and neuroses.Clinical ImplicationsIt may be necessary to establish clearer, consistent boundaries in order to consolidate services for patients with severe mental health problems.

Background in recent years there has been much emphasis on ‘research waste’ caused by poor question selection, insufficient attention to previous research results, and avoidable weakness in research design, conduct and analysis. Little attention has been paid to the effect of inadequate development of interventions before proceeding to a full clinical trial. Objective We therefore propose to enrich the development phase of the MRC Framework by adding crucial elements to improve the likelihood of success and enhance the fit with clinical practice Methods Based on existing intervention development guidance and synthesis, a comprehensive iterative intervention development approach is proposed. Examples from published reports are presented to illustrate the methodology that can be applied within each element to enhance the intervention design. Results a comprehensive iterative approach is presented by combining the elements of the MRC Framework development phase with essential elements from existing guidance including: problem identification, the systematic identification of evidence, identification or development of theory, determination of needs, the examination of current practice and context, modelling the process and expected outcomes leading to final element: the intervention design. All elements are drawn from existing models to provide intervention developers with a greater chance of producing an intervention that is well adopted, effective and fitted to the context. Conclusion This comprehensive approach of developing interventions will strengthen the internal and external validity, minimize research waste and add value to health care research. In complex interventions in health care research, flaws in the development process immediately impact the chances of success. Knowledge regarding the causal mechanisms and interactions within the intended clinical context is needed to develop interventions that fit daily practice and are beneficial for the end-user.

OBJECTIVE: to address uncertainties prior to conducting a fully powered randomised controlled trial of Morita Therapy plus treatment as usual (TAU) versus TAU alone, or to determine that such a trial is not appropriate and/or feasible. DESIGN: Pilot parallel group randomised controlled feasibility trial. SETTING AND PARTICIPANTS: Participants aged ≥18 years with Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV major depressive disorder, with or without DSM-IV anxiety disorder(s), recruited from general practice record searches in Devon, UK. INTERVENTIONS: We randomised participants on a 1:1 basis stratified by symptom severity, concealing allocation using a secure independent web-based system, to receive TAU (control) or 8-12 sessions of Morita Therapy, a Japanese psychological therapy, plus TAU (intervention). OUTCOMES: Rates of recruitment, retention and treatment adherence; variance and estimated between-group differences in follow-up scores (on the Patient Health Questionnaire 9 (PHQ-9) (depressive symptoms); Generalised Anxiety Disorder Questionnaire 7 (anxiety symptoms); Short Form 36 Health Survey Questionnaire/Work and Social Adjustment Scale (quality of life); Morita Attitudinal Scale for Arugamama (attitudes)) and their correlation with baseline scores. RESULTS: We recruited 68 participants, 5.1% (95% CI 3.4% to 6.6%) of those invited (34 control; 34 intervention); 64/68 (94%; 95% CI 88.3% to 99.7%) provided 4-month follow-up data. Participants had a mean age of 49 years and mean PHQ-9 score of 16.8; 61% were female. Twenty-four of 34 (70.6%) adhered to the minimum treatment dose. The follow-up PHQ-9 (future primary outcome measure) pooled SD was 6.4 (95% CI 5.5 to 7.8); the magnitude of correlation between baseline and follow-up PHQ-9 scores was 0.42 (95% CI 0.19 to 0.61). of the participants, 66.7% and 30.0% recovered in the intervention and control groups, respectively; 66.7% and 13.3% responded to treatment in the intervention and control groups, respectively. CONCLUSIONS: a large-scale trial of Morita Therapy would require 133 participants per group and is feasible with minor modifications to the pilot trial protocol. Morita Therapy shows promise in treating depression and may provide patients with a distinct alternative to current treatments. TRIAL REGISTRATION NUMBER: ISRCTN17544090; Pre-results.

Background: European research in nursing has been criticized as overwhelmingly descriptive, wasteful and with little relevance to clinical practice. This second triennial review follows our previous review of articles published in 2010, to determine whether the situation has changed. Objective: to identify, appraise, and synthesize reports of European nursing research published during 2013 in the top 20 nursing research journals. Methods: Systematic review with descriptive results synthesis. Results: We identified 2,220 reports, of which 254, from 19 European countries, were eligible for analysis; 215 (84.7%) were primary research, 36 (14.2%) secondary research, and three (1.2%) mixed primary and secondary. Forty-eight (18.9%) of studies were experimental: 24 (9.4%) randomized controlled trials, 11 (4.3%) experiments without randomization, and 13 (5.1%) experiments without control group. A total of 106 (41.7%) articles were observational: 85 (33.5%) qualitative research. The majority (158; 62.2%) were from outpatient and secondary care hospital settings. One hundred and sixty-five (65.0%) articles reported nursing intervention studies: 77 (30.3%) independent interventions, 77 (30.3%) interdependent, and 11 (4.3%) dependent. This represents a slight increase in experimental studies compared with our previous review (18.9% vs. 11.7%). The quality of reporting remained very poor. Linking Evidence to Action: European research in nursing remains overwhelmingly descriptive. We call on nursing researchers globally to raise the level of evidence and, therefore, the quality of care and patient outcomes. We urge them to replicate our study in their regions, diagnose reasons for the lack of appropriate research, identify solutions, and implement a deliberate, targeted, and systematic global effort to increase the number of experimental, high quality, and relevant studies into nursing interventions. We also call on journal editors to mandate an improvement in the standards of research reporting in nursing journals.

© Queen’s Printer and Controller of HMSO 2017. Background: Efforts to reduce the burden of illness and personal suffering associated with depression in older adults have focused on those with more severe depressive syndromes. Less attention has been paid to those with mild disorders/subthreshold depression, but these patients also suffer significant impairments in their quality of life and level of functioning. There is currently no clear evidence-based guidance regarding treatment for this patient group. Objectives: to establish the clinical effectiveness and cost-effectiveness of a low-intensity intervention of collaborative care for primary care older adults who screened positive for subthreshold depression. Design: a pragmatic, multicentred, two-arm, parallel, individually randomised controlled trial with a qualitative study embedded within the pilot. Randomisation occurred after informed consent and baseline measures were collected. Setting: Thirty-two general practitioner (GP) practices in the north of England. Participants: a total of 705 participants aged ≥ 75 years during the pilot phase and ≥ 65 years during the main trial with subthreshold depression. Interventions: Participants in the intervention group received a low-intensity intervention of collaborative care, which included behavioural activation delivered by a case manager for an average of six sessions over 7–8 weeks, alongside usual GP care. Control-arm participants received only usual GP care. Main outcome measures: the primary outcome measure was a self-reported measure of depression severity, the Patient Health Questionnaire-9 items PHQ-9 score at 4 months post randomisation. Secondary outcome measures included the European Quality of Life-5 Dimensions, Short Form questionnaire-12 items, Patient Health Questionnaire-15 items, Generalised Anxiety Disorder seven-item scale, Connor–Davidson Resilience Scale two-item version, a medication questionnaire and objective data. Participants were followed up for 12 months. Results: in total, 705 participants were randomised (collaborative care n = 344, usual care n = 361), with 586 participants (83%; collaborative care 76%, usual care 90%) followed up at 4 months and 519 participants (74%; collaborative care 68%, usual care 79%) followed up at 12 months. Attrition was markedly greater in the collaborative care arm. Model estimates at the primary end point of 4 months revealed a statistically significant effect in favour of collaborative care compared with usual care [mean difference 1.31 score points, 95% confidence interval (CI) 0.67 to 1.95 score points; p < 0.001]. The difference equates to a standard effect size of 0.30, for which the trial was powered. Treatment differences measured by the PHQ-9 were maintained at 12 months’ follow-up (mean difference 1.33 score points, 95% CI 0.55 to 2.10 score points; p = 0.001). Base-case cost-effectiveness analysis found that the incremental cost-effectiveness ratio was £9633 per quality-adjusted life-year (QALY). On average, participants allocated to collaborative care displayed significantly higher QALYs than those allocated to the control group (annual difference in adjusted QALYs of 0.044, 95% bias-corrected CI 0.015 to 0.072; p = 0.003). Conclusions: Collaborative care has been shown to be clinically effective and cost-effective for older adults with subthreshold depression and to reduce the proportion of people who go on to develop case-level depression at 12 months. This intervention could feasibly be delivered in the NHS at an acceptable cost–benefit ratio. Important future work would include investigating the longer-term effect of collaborative care on the CASPER population, which could be conducted by introducing an extension to follow-up, and investigating the impact of collaborative care on managing multimorbidities in people with subthreshold depression.

© Queen’s Printer and Controller of HMSO 2017. Background: Depression in older adults is common and is associated with poor quality of life, increased morbidity and early mortality, and increased health and social care use. Collaborative care, a low-intensity intervention for depression that is shown to be effective in working-age adults, has not yet been evaluated in older people with depression who are managed in UK primary care. The CollAborative care for Screen-Positive EldeRs (CASPER) plus trial fills the evidence gap identified by the most recent guidelines on depression management. Objectives: to establish the clinical effectiveness and cost-effectiveness of collaborative care for older adults with major depressive disorder in primary care. Design: a pragmatic, multicentred, two-arm, parallel, individually randomised controlled trial with embedded qualitative study. Participants were automatically randomised by computer, by the York Trials Unit Randomisation Service, on a 1:1 basis using simple unstratified randomisation after informed consent and baseline measures were collected. Blinding was not possible. Setting: Sixty-nine general practices in the north of England. Participants: a total of 485 participants aged ≥ 65 years with major depressive disorder. Interventions: a low-intensity intervention of collaborative care, including behavioural activation, delivered by a case manager for an average of six sessions over 7-8 weeks, alongside usual general practitioner (GP) care. The control arm received only usual GP care. Main outcome measures: the primary outcome measure was Patient Health Questionnaire-9 items score at 4 months post randomisation. Secondary outcome measures included depression severity and caseness at 12 and 18 months, the EuroQol-5 Dimensions, Short Form questionnaire-12 items, Patient Health Questionnaire-15 items, Generalised Anxiety Disorder-7 items, Connor-Davidson Resilience Scale-2 items, a medication questionnaire, objective data and adverse events. Participants were followed up at 12 and 18 months. Results: in total, 485 participants were randomised (collaborative care, n = 249; usual care, n = 236), with 390 participants (80%: collaborative care, 75%; usual care, 86%) followed up at 4 months, 358 participants (74%: collaborative care, 70%; usual care, 78%) followed up at 12 months and 344 participants (71%: collaborative care, 67%; usual care, 75%) followed up at 18 months. A total of 415 participants were included in primary analysis (collaborative care, n = 198; usual care, n = 217), which revealed a statistically significant effect in favour of collaborative care at the primary end point at 4 months [8.98 vs. 10.90 score points, mean difference 1.92 score points, 95% confidence interval (CI) 0.85 to 2.99 score points; p < 0.001], equivalent to a standard effect size of 0.34. However, treatment differences were not maintained in the longer term (at 12 months: 0.19 score points, 95% CI-0.92 to 1.29 score points; p = 0.741; at 18 months: < 0.01 score points, 95% CI-1.12 to 1.12 score points; p = 0.997). The study recorded details of all serious adverse events (SAEs), which consisted of ‘unscheduled hospitalisation’, ‘other medically important condition’ and ‘death’. No SAEs were related to the intervention. Collaborative care showed a small but non-significant increase in quality-adjusted life-years (QALYs) over the 18-month period, with a higher cost. Overall, the mean cost per incremental QALY for collaborative care compared with usual care was £26,016; however, for participants attending six or more sessions, collaborative care appears to represent better value for money (£9876/QALY). Limitations: Study limitations are identified at different stages: design (blinding unfeasible, potential contamination), process (relatively low overall consent rate, differential attrition/retention rates) and analysis (no baseline health-care resource cost or secondary/social care data). Conclusion: Collaborative care was effective for older people with case-level depression across a range of outcomes in the short term though the reduction in depression severity was not maintained over the longer term of 12 or 18 months. Participants who received six or more sessions of collaborative care did benefit substantially more than those who received fewer treatment sessions but this difference was not statistically significant. Future work recommendations: Recommendations for future research include investigating the longer-term effect of the intervention. Depression is a recurrent disorder and it would be useful to assess its impact on relapse and the prevention of future case-level depression.

BACKGROUND: Depression is a common, debilitating and costly disorder. The best-evidenced psychological therapy - cognitive-behavioural therapy (CBT) - is complex and costly. A simpler therapy, behavioural activation (BA), may be an effective alternative. OBJECTIVES: to determine the clinical effectiveness and cost-effectiveness of BA compared with CBT for depressed adults at 12 and 18 months' follow-up, and to investigate the processes of treatments. DESIGN: Randomised controlled, non-inferiority trial stratified by depression severity, antidepressant use and recruitment site, with embedded process evaluation; and randomisation by remote computer-generated allocation. SETTING: Three community mental health services in England. PARTICIPANTS: Adults aged ≥ 18 years with major depressive disorder (MDD) recruited from primary care and psychological therapy services. INTERVENTIONS: BA delivered by NHS junior mental health workers (MHWs); CBT by NHS psychological therapists. OUTCOMES: Primary: depression severity (as measured via the Patient Health Questionnaire-9; PHQ-9) at 12 months. Secondary: MDD status; number of depression-free days; anxiety (as measured via the Generalised Anxiety Disorder-7); health-related quality of life (as measured via the Short Form questionnaire-36 items) at 6, 12 and 18 months; and PHQ-9 at 6 and 18 months, all collected by assessors blinded to treatment allocation. Non-inferiority margin was 1.9 PHQ-9 points. We undertook intention-to-treat (ITT) and per protocol (PP) analyses. We explored cost-effectiveness by collecting direct treatment and other health- and social-care costs and calculating quality-adjusted life-years (QALYs) using the EuroQol-5 Dimensions, three-level version, at 18 months. RESULTS: We recruited 440 participants (BA, n = 221; CBT, n = 219); 175 (79%) BA and 189 (86%) CBT participants provided ITT data and 135 (61%) BA and 151 (69%) CBT participants provided PP data. At 12 months we found that BA was non-inferior to CBT {ITT: CBT 8.4 PHQ-9 points [standard deviation (SD) 7.5 PHQ-9 points], BA 8.4 PHQ-9 points (SD 7.0 PHQ-9 points), mean difference 0.1 PHQ-9 points, 95% confidence interval (CI) -1.3 to 1.5 PHQ-9 points, p = 0.89; PP: CBT 7.9 PHQ-9 points (SD 7.3 PHQ-9 points), BA 7.8 PHQ-9 points (SD 6.5 PHQ-9 points), mean difference 0.0 PHQ-9 points, 95% CI -1.5 to 1.6 PHQ-9 points, p = 0.99}. We found no differences in secondary outcomes. We found a significant difference in mean intervention costs (BA, £975; CBT, £1235; p 

Objective to explore participant views on acceptability, mechanisms of change and impact of behavioural activation (BA) delivered by junior mental health workers (MHWs) versus cognitive behavioural therapy (CBT) delivered by professional psychotherapists. Design Semistructured qualitative interviews analysed using a framework approach. Participants 36 participants with major depressive disorder purposively sampled from a randomised controlled trial of BA versus CBT (the COBRA trial). Setting Primary care psychological therapies services in Devon, Durham and Leeds, UK. Results Elements of therapy considered to be beneficial included its length and regularity, the opportunity to learn and not dwelling on the past. Homework was an important, although challenging aspect of treatment. Therapists were perceived as experts who played an important role in treatment. For some participants the most important element of therapy was having someone to talk to, but for others the specific factors associated with BA and CBT were crucial, with behavioural change considered important for participants in both treatments, and cognitive change unsurprisingly discussed more by those receiving CBT. Both therapies were considered to have a positive impact on symptoms of depression and other areas of life including feelings about themselves, self-care, work and relationships. Barriers to therapy included work, family life and emotional challenges. A subset (n=2) of BA participants commented that therapy felt too simple, and MHWs could be perceived as inexperienced. Many participants saw therapy as a learning experience, providing them with tools to take away, with work on relapse prevention essential. Conclusions Despite barriers for some participants, BA and CBT were perceived to have many benefits, to have brought about cognitive and behavioural change and to produce improvements in many domains of participants' lives. To optimise the delivery of BA, inexperienced junior MHWs should be supported through good quality training and ongoing supervision.

IMPORTANCE: There is little evidence to guide management of depressive symptoms in older people. OBJECTIVE: to evaluate whether a collaborative care intervention can reduce depressive symptoms and prevent more severe depression in older people. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted from May 24, 2011, to November 14, 2014, in 32 primary care centers in the United Kingdom among 705 participants aged 65 years or older with Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) subthreshold depression; participants were followed up for 12 months. INTERVENTIONS: Collaborative care (n=344) was coordinated by a case manager who assessed functional impairments relating to mood symptoms. Participants were offered behavioral activation and completed an average of 6 weekly sessions. The control group received usual primary care (n=361). MAIN OUTCOMES AND MEASURES: the primary outcome was self-reported depression severity at 4-month follow-up on the 9-item Patient Health Questionnaire (PHQ-9; score range, 0-27). Included among 10 prespecified secondary outcomes were the PHQ-9 score at 12-month follow-up and the proportion meeting criteria for depressive disorder (PHQ-9 score ≥10) at 4- and 12-month follow-up. RESULTS: the 705 participants were 58% female with a mean age of 77 (SD, 7.1) years. Four-month retention was 83%, with higher loss to follow-up in collaborative care (82/344 [24%]) vs usual care (37/361 [10%]). Collaborative care resulted in lower PHQ-9 scores vs usual care at 4-month follow-up (mean score with collaborative care, 5.36 vs with usual care, 6.67; mean difference, -1.31; 95% CI, -1.95 to -0.67; P 

BACKGROUND: the aim of this paper is to showcase best practice in intervention development by illustrating a systematic, iterative, person-based approach to optimising intervention acceptability and feasibility, as applied to the cross-cultural adaptation of Morita therapy for depression and anxiety. METHODS: We developed the UK Morita therapy outpatient protocol over four stages integrating literature synthesis and qualitative research. Firstly, we conducted in-depth interviews combining qualitative and cognitive interviewing techniques, utilising vignettes of Morita therapy being delivered and analysed using Framework analysis to investigate potential patients and therapists' perceptions of Morita therapy. Secondly, we developed qualitative themes into recommendations for optimising Morita therapy and synthesised Morita therapy literature in line with these to develop a draft protocol. Thirdly, we conducted repeat interviews with therapists to investigate their views of the protocol. Finally, we responded to these qualitative themes through protocol modification and tailoring our therapist training programme. RESULTS: As a consequence of literature describing Morita therapy and participants' perceptions of the approach, we developed both a therapy protocol and therapist training programme which were fit for purpose in proceeding to a UK-based Morita therapy feasibility study. As per our key qualitative findings and resulting recommendations, we structured our protocol according to the four-phased model of Morita therapy, included detailed guidance and warning points, and supported therapists in managing patients' expectations of the approach. CONCLUSIONS: Our systematic approach towards optimising intervention acceptability and feasibility prioritises the perspectives of those who will deliver and receive the intervention. Thus, we both showcase best practice in intervention development and demonstrate the application of this process to the careful cross-cultural adaptation of an intervention in which balancing both optimisation of and adherence to the approach are key. This presentation of a generalisable process in a transparent and replicable manner will be of interest to those both developing and evaluating complex interventions in the future.

OBJECTIVE: to explore patients' and nurses' views on the feasibility and acceptability of providing psychological care within cardiac rehabilitation services. DESIGN: In-depth interviews analysed thematically. PARTICIPANTS: 18 patients and 7 cardiac nurses taking part in a pilot trial (CADENCE) of an enhanced psychological care intervention delivered within cardiac rehabilitation programmes by nurses to patients with symptoms of depression. SETTING: Cardiac services based in the South West of England and the East Midlands, UK. RESULTS: Patients and nurses viewed psychological support as central to good cardiac rehabilitation. Patients' accounts highlighted the significant and immediate adverse effect a cardiac event can have on an individual's mental well-being. They also showed that patients valued nurses attending to both their mental and physical health, and felt this was essential to their overall recovery. Nurses were committed to providing psychological support, believed it benefited patients, and advocated for this support to be delivered within cardiac rehabilitation programmes rather than within a parallel healthcare service. However, nurses were time-constrained and found it challenging to provide psychological care within their existing workloads. CONCLUSIONS: Both patients and nurses highly value psychological support being delivered within cardiac rehabilitation programmes but resource constraints raise barriers to implementation. Consideration, therefore, should be given to alternative forms of delivery which do not rely solely on nurses to enable patients to receive psychological support during cardiac rehabilitation. TRIAL REGISTRATION NUMBER: ISCTRN34701576.

Shape of change, sudden gains and depression spikes were examined in an online 12-session Behavioral Activation (BA) treatment for depression. Client and therapist factors related to sudden gains were examined to investigate processes associated with outcome. Methods: Participants were postpartum Women with Major Depressive Disorder (n=42) who received online BA supported in 30-minute telephone sessions by a mental health worker. Depression symptoms were assessed at each session and number of sessions completed were recorded by the online program. Therapist records were rated for client stressful life event and therapist concrete focus. A quadratic pattern provided the best fit with the data; a cubic pattern was a poor fit. Sudden gains, but not depression spikes, predicted lower depression scores at 17-week outcome. Women who had higher baseline social functioning, did not experience a stressful life event during therapy, and completed more online modules, but not more telephone sessions, were more likely to have a sudden gain. A concrete therapist focus was associated with sudden gains. These results extend research on trajectories of change and sudden gains to an online BA treatment and to postpartum depression, and suggest important client and therapist factors associated with sudden gains.

BACKGROUND: Interventions aiming to coordinate services for the community-based dementia population vary in components, organisation and implementation. In this review we aimed to investigate the views of stakeholders on the key components of community-based interventions coordinating care in dementia. METHODS: We searched four databases from inception to June 2015; Medline, the Cochrane Library, EMBASE and PsycINFO, this was aided by a search of four grey literature databases, and backward and forward citation tracking of included papers. Title and abstract screening was followed by a full text screen by two independent reviewers, and quality was assessed using the CASP appraisal tool. We then conducted thematic synthesis on extracted data. RESULTS: a total of seven papers from five independent studies were included in the review, and encompassed the views of over 100 participants from three countries. Through thematic synthesis we identified 32 initial codes that were grouped into 5 second-order themes: (1) case manager had four associated codes and described preferences for the case manager personal and professional attributes, including a sound knowledge in dementia and availability of local services; (2) communication had five associated codes and emphasized the importance stakeholders placed on multichannel communication with service users, as well as between multidisciplinary teams and across organisations; (3) intervention had 11 associated codes which focused primarily on the practicalities of implementation such as the contact type and frequency between case managers and service users, and the importance of case manager training and service evaluation; (4) resources had five associated codes which outlined stakeholder views on the required resources for coordinating interventions and potential overlap with existing resources, as well as arising issues when available resources do not meet those required for successful implementation; and (5) support had seven associated codes that reflect the importance that was placed on the support network around the case manager and the investment of professionals involved directly in care as well as the wider professional network. CONCLUSION: the synthesis of relevant qualitative studies has shown how various stakeholder groups considered dementia care coordination interventions to be acceptable, useful and appropriate for dementia care, and have clear preferences for components, implementation methods and settings of these interventions. By incorporating stakeholders' perspectives and preferences when planning and developing coordinating interventions we may increase the likelihood of successful implementation and patient benefits.

BackgroundComputerised cognitive-behavioural therapy (cCBT) for depression has the potential to be efficient therapy but engagement is poor in primary care trials.AimsWe tested the benefits of adding telephone support to cCBT.MethodWe compared telephone-facilitated cCBT (MoodGYM) (n = 187) to minimally supported cCBT (MoodGYM) (n = 182) in a pragmatic randomised trial (trial registration: ISRCTN55310481). Outcomes were depression severity (Patient Health Questionnaire (PHQ)-9), anxiety (Generalized Anxiety Disorder Questionnaire (GAD)-7) and somatoform complaints (PHQ-15) at 4 and 12 months.ResultsUse of cCBT increased by a factor of between 1.5 and 2 with telephone facilitation. At 4 months PHQ-9 scores were 1.9 points lower (95% CI 0.5-3.3) for telephone-supported cCBT. At 12 months, the results were no longer statistically significant (0.9 PHQ-9 points, 95% CI -0.5 to 2.3). There was improvement in anxiety scores and for somatic complaints.ConclusionsTelephone facilitation of cCBT improves engagement and expedites depression improvement. The effect was small to moderate and comparable with other low-intensity psychological interventions.

BACKGROUND: Interventions aiming to coordinate services for the community-based dementia population vary in components, organisation and implementation. In this review we aimed to evaluate the effectiveness of community-based care coordinating interventions on health outcomes and investigate whether specific components of interventions influence their effects. METHODS: We searched four databases from inception to April 2017: Medline, the Cochrane Library, EMBASE and PsycINFO. This was aided by a search of four grey literature databases, and backward and forward citation tracking of included papers. Title and abstract screening was followed by a full text screen by two independent reviewers, and quality was assessed using the CASP appraisal tool. We then conducted meta-analyses and subgroup analyses. RESULTS: a total of 14 randomised controlled trials (RCTs) involving 10,372 participants were included in the review. Altogether we carried out 12 meta-analyses and 19 subgroup analyses. Meta-analyses found coordinating interventions showed a statistically significant improvement in both patient behaviour measured using the Neuropsychiatric Inventory (NPI) (mean difference (MD) = -9.5; 95% confidence interval (CI): -18.1 to -1.0; p = 0.03; number of studies (n) = 4; I2 = 88%) and caregiver burden (standardised mean difference (SMD) = -0.54; 95% CI: -1.01 to -0.07; p = 0.02; n = 5, I2 = 92%) compared to the control group. Subgroup analyses found interventions using a case manager with a nursing background showed a greater positive effect on caregiver quality of life than those that used case managers from other professional backgrounds (SMD = 0.94 versus 0.03, respectively; p 

BACKGROUND: Around 17% of people eligible for UK cardiac rehabilitation programmes following an acute coronary syndrome report moderate or severe depressive symptoms. While maximising psychological health is a core goal of cardiac rehabilitation, psychological care can be fragmented and patchy. This study tests the feasibility and acceptability of embedding enhanced psychological care, composed of two management strategies of proven effectiveness in other settings (nurse-led mental health care coordination and behavioural activation), within the cardiac rehabilitation care pathway. METHODS/DESIGN: This study tests the uncertainties associated with a large-scale evaluation by conducting an external pilot trial with a nested qualitative study. We aim to recruit and randomise eight comprehensive cardiac rehabilitation teams (clusters) to intervention (embedding enhanced psychological care into routine cardiac rehabilitation programmes) or control (routine cardiac rehabilitation programmes alone) arms. Up to 64 patients (eight per team) identified with depressive symptoms upon initial assessment by the cardiac rehabilitation team will be recruited, and study measures will be administered at baseline (before starting rehabilitation) and at 5 months and 8 months post baseline. Outcomes include depressive symptoms, cardiac mortality and morbidity, anxiety, health-related quality of life and service resource use. Trial data on cardiac team and patient recruitment, and the retention and flow of patients through treatment will be used to assess intervention feasibility and acceptability. Qualitative interviews will be undertaken to explore trial participants' and cardiac rehabilitation nurses' views and experiences of the trial methods and intervention, and to identify reasons why patients declined to take part in the trial. Outcome data will inform a sample size calculation for a definitive trial. DISCUSSION: the pilot trial and qualitative study will inform the design of a fully powered cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of the provision of enhanced psychological care within cardiac rehabilitation programmes. TRIAL REGISTRATION: ISRCTN34701576 (Registered 29 May 2014).

IMPORTANCE: Collaborative care is an intensive care model involving several health care professionals working together, typically a physician, a case manager, and a mental health professional. Meta-analyses of aggregate data have shown that collaborative care is particularly effective in people with depression and comorbid chronic physical conditions. However, only participant-level analyses can rigorously test whether the treatment effect is influenced by participant characteristics, such as chronic physical conditions. OBJECTIVE: to assess whether the effectiveness of collaborative care for depression is moderated by the presence, type, and number of chronic physical conditions. DATA SOURCES: Data were obtained from MEDLINE, EMBASE, PubMed, PsycINFO, CINAHL Complete, and Cochrane Central Register of Controlled Trials, and references from relevant systematic reviews. The search and collection of eligible studies was ongoing until May 22, 2015. STUDY SELECTION: This was an update to a previous meta-analysis. Two independent reviewers were involved in the study selection process. Randomized clinical trials that compared the effectiveness of collaborative care with usual care in adults with depression and reported measured changes in depression severity symptoms at 4 to 6 months after randomization were included in the analysis. Key search terms included depression, dysthymia, anxiety, panic, phobia, obsession, compulsion, posttraumatic, care management, case management, collaborative care, enhanced care, and managed care. DATA EXTRACTION AND SYNTHESIS: Individual participant data on baseline demographics and chronic physical conditions as well as baseline and follow-up depression severity symptoms were requested from authors of the eligible studies. One-step meta-analysis of individual participant data using appropriate mixed-effects models was performed. MAIN OUTCOMES AND MEASURES: Continuous outcomes of depression severity symptoms measured using self-reported or observer-rated measures. RESULTS: Data sets from 31 randomized clinical trials including 36 independent comparisons (N = 10 962 participants) were analyzed. Individual participant data analyses found no significant interaction effects, indicating that the presence (interaction coefficient, 0.02 [95% CI, -0.10 to 0.13]), numbers (interaction coefficient, 0.01 [95% CI, -0.01 to 0.02]), and types of chronic physical conditions do not influence the treatment effect. CONCLUSIONS AND RELEVANCE: There is evidence that collaborative care is effective for people with depression alone and also for people with depression and chronic physical conditions. Existing guidance that recommends limiting collaborative care to people with depression and physical comorbidities is not supported by this individual participant data meta-analysis.

BACKGROUND: Collaborative care is effective for depression management in the USA. There is little UK evidence on its clinical effectiveness and cost-effectiveness. OBJECTIVE: to determine the clinical effectiveness and cost-effectiveness of collaborative care compared with usual care in the management of patients with moderate to severe depression. DESIGN: Cluster randomised controlled trial. SETTING: UK primary care practices (n = 51) in three UK primary care districts. PARTICIPANTS: a total of 581 adults aged ≥ 18 years in general practice with a current International Classification of Diseases, Tenth Edition depressive episode, excluding acutely suicidal people, those with psychosis, bipolar disorder or low mood associated with bereavement, those whose primary presentation was substance abuse and those receiving psychological treatment. INTERVENTIONS: Collaborative care: 14 weeks of 6-12 telephone contacts by care managers; mental health specialist supervision, including depression education, medication management, behavioural activation, relapse prevention and primary care liaison. Usual care was general practitioner standard practice. MAIN OUTCOME MEASURES: Blinded researchers collected depression [Patient Health Questionnaire-9 (PHQ-9)], anxiety (General Anxiety Disorder-7) and quality of life (European Quality of Life-5 Dimensions three-level version), Short Form questionnaire-36 items) outcomes at 4, 12 and 36 months, satisfaction (Client Satisfaction Questionnaire-8) outcomes at 4 months and treatment and service use costs at 12 months. RESULTS: in total, 276 and 305 participants were randomised to collaborative care and usual care respectively. Collaborative care participants had a mean depression score that was 1.33 PHQ-9 points lower [n = 230; 95% confidence interval (CI) 0.35 to 2.31; p = 0.009] than that of participants in usual care at 4 months and 1.36 PHQ-9 points lower (n = 275; 95% CI 0.07 to 2.64; p = 0.04) at 12 months after adjustment for baseline depression (effect size 0.28, 95% CI 0.01 to 0.52; odds ratio for recovery 1.88, 95% CI 1.28 to 2.75; number needed to treat 6.5). Quality of mental health but not physical health was significantly better for collaborative care at 4 months but not at 12 months. There was no difference for anxiety. Participants receiving collaborative care were significantly more satisfied with treatment. Differences between groups had disappeared at 36 months. Collaborative care had a mean cost of £272.50 per participant with similar health and social care service use between collaborative care and usual care. Collaborative care offered a mean incremental gain of 0.02 (95% CI -0.02 to 0.06) quality-adjusted life-years (QALYs) over 12 months at a mean incremental cost of £270.72 (95% CI -£202.98 to £886.04) and had an estimated mean cost per QALY of £14,248, which is below current UK willingness-to-pay thresholds. Sensitivity analyses including informal care costs indicated that collaborative care is expected to be less costly and more effective. The amount of participant behavioural activation was the only effect mediator. CONCLUSIONS: Collaborative care improves depression up to 12 months after initiation of the intervention, is preferred by patients over usual care, offers health gains at a relatively low cost, is cost-effective compared with usual care and is mediated by patient activation. Supervision was by expert clinicians and of short duration and more intensive therapy may have improved outcomes. In addition, one participant requiring inpatient treatment incurred very significant costs and substantially inflated our cost per QALY estimate. Future work should test enhanced intervention content not collaborative care per se. TRIAL REGISTRATION: Current Controlled Trials ISRCTN32829227. FUNDING: This project was funded by the Medical Research Council (MRC) (G0701013) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership.

Background and purpose: a significant number of stroke survivors will not recover the use of their affected arm. A proportion will experience pain, stiffness and difficulty with basic care activities. The purpose of the review was to identify predictors of difficulty caring for the profoundly affected arm and establish the incidence and time-course of the related impairments of pain, spasticity and contracture. Method: Data sources: Databases (PubMED, MEDLINE, AMED, EMBASE, CINAHL and the Cochrane Controlled Trials Register) were searched from inception to December 2013. Additional studies were identified from citation tracking. Review methods: Independent reviewers used pre-defined criteria to identify eligible studies. Quality assessment and risk of bias were assessed using the McMasters Assessment Tool. A narrative evidence synthesis was performed. Results: Thirty-nine articles reporting 34 studies were included. No studies formally measured difficulty caring for the arm, but related impairments were common. Incidence of spasticity in those with weakness ranged from 33% to 78%, shoulder pain affected 22% to 90% and contracture was present in at least 50%. Spasticity and pain appear within 1 week of stroke, and contracture within two weeks. Impairments continued to develop over at least 3–6 months. The most frequent predictors of spasticity and contracture were weakness and reduced motor control, and the risk of pain is most commonly predicted by reduced sensation, shoulder subluxation, weakness and stroke severity. Discussion: There is no published evidence on predicting the likelihood of difficulty caring for the arm following stroke. However, the related impairments of spasticity, pain and contracture are common. Given the time-course of development, clinicians may need not only to intervene early but also be prepared to act over a longer time period. Further research is needed to examine difficulty caring for the arm and the relationship with associated impairments to enable researchers and clinicians to develop targeted interventions. © 2015 the Authors. Physiotheraphy Research International Published by John Wiley & Sons Ltd.

KEYNOTE PRESENTATIONS K1 Researching complex interventions: the need for robust approaches Peter Craig K2 Complex intervention studies: an important step in developing knowledge for practice Ingalill Rahm-Hallberg K3 Public and patient involvement in research: what, why and how? Nicky Britten K4 Mixed methods in health service research – where do we go from here? Gunilla Borglin SPEAKER PRESENTATIONS S1 Exploring complexity in systematic reviews of complex interventions Gabriele Meyer, Sascha Köpke, Jane Noyes, Jackie Chandler S2 can complex health interventions be optimised before moving to a definitive RCT? Strategies and methods currently in use Sara Levati S3 a systematic approach to develop theory based implementation interventions Anne Sales S4 Pilot studies and feasibility studies for complex interventions: an introduction Lehana Thabane, Lora Giangregorio S5 What can be done to pilot complex interventions? Nancy Feeley, Sylvie Cossette S6 Using feasibility and pilot trials to test alternative methodologies and methodological procedures prior to full scale trials Rod Taylor S7 a mixed methods feasibility study in practice Jacqueline Hill, David a Richards, Willem Kuyken S8 Non-standard experimental designs and preference designs Louise von Essen S9 Evaluation gone wild: using natural experimental approaches to evaluate complex interventions Andrew Williams S10 the stepped wedge cluster randomised trial: an opportunity to increase the quality of evaluations of service delivery and public policy interventions Karla Hemming, Richard Lilford, Alan Girling, Monica Taljaard S11 Adaptive designs in confirmatory clinical trials: opportunities in investigating complex interventions Munyaradzi Dimairo S12 Processes, contexts and outcomes in complex interventions, and the implications for evaluation Mark Petticrew S13 Processes, contexts and outcomes in complex interventions, and the implications for evaluation Janis Baird, Graham Moore S14 Qualitative evaluation alongside RCTs: what to consider to get relevant and valuable results Willem Odendaal, Salla Atkins, Elizabeth Lutge, Natalie Leon, Simon Lewin S15 Using economic evaluations to understand the value of complex interventions: when maximising health status is not sufficient Katherine Payne S16 How to arrive at an implementation plan Theo van Achterberg S17 Modelling process and outcomes in complex interventions Walter Sermeus S18 Systems modelling for improving health care Martin Pitt, Thomas Monks

BACKGROUND: Computerised cognitive behaviour therapy (cCBT) is an efficient form of therapy potentially improving access to psychological care. Indirect evidence suggests that the uptake and effectiveness of cCBT can be increased if facilitated by telephone, but this is not routinely offered in the NHS. OBJECTIVES: to compare the clinical effectiveness and cost-effectiveness of telephone-facilitated free-to-use cCBT [e.g. MoodGYM (National Institute for Mental Health Research, Australian National University, Canberra, ACT, Australia)] with minimally supported cCBT. DESIGN: This study was a multisite, pragmatic, open, two-arm, parallel-group randomised controlled trial with a concurrent economic evaluation. SETTING: Participants were recruited from GP practices in Bristol, Manchester, Sheffield, Hull and the north-east of England. PARTICIPANTS: Potential participants were eligible to participate in the trial if they were adults with depression scoring ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9). INTERVENTIONS: Participants were randomised using a computer-generated random number sequence to receive minimally supported cCBT or telephone-facilitated cCBT. Participants continued with usual general practitioner care. MAIN OUTCOME MEASURES: the primary outcome was self-reported symptoms of depression, as assessed by the PHQ-9 at 4 months post randomisation. SECONDARY OUTCOMES: Secondary outcomes were depression at 12 months and anxiety, somatoform complaints, health utility (as assessed by the European Quality of Life-5 Dimensions questionnaire) and resource use at 4 and 12 months. RESULTS: Clinical effectiveness: 182 participants were randomised to minimally supported cCBT and 187 participants to telephone-facilitated cCBT. There was a difference in the severity of depression at 4 and 12 months, with lower levels in the telephone-facilitated group. The odds of no longer being depressed (defined as a PHQ-9 score of

BACKGROUND: Computerised cognitive behaviour therapy (cCBT) has been developed as an efficient form of therapy delivery with the potential to enhance access to psychological care. Independent research is needed which examines both the clinical effectiveness and cost-effectiveness of cCBT over the short and longer term. OBJECTIVES: to compare the clinical effectiveness and cost-effectiveness of cCBT as an adjunct to usual general practitioner (GP) care against usual GP care alone, for a free-to-use cCBT program (MoodGYM; National Institute for Mental Health Research, Australian National University, Canberra, Australia) and a commercial pay-to-use cCBT program (Beating the Blues(®); Ultrasis, London, UK) for adults with depression, and to determine the acceptability of cCBT and the experiences of users. DESIGN: a pragmatic, multicentre, three-armed, parallel, randomised controlled trial (RCT) with concurrent economic and qualitative evaluations. Simple randomisation was used. Participants and researchers were not blind to treatment allocation. SETTING: Primary care in England. PARTICIPANTS: Adults with depression who scored ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9). INTERVENTIONS: Participants who were randomised to either of the two intervention groups received cCBT (Beating the Blues or MoodGYM) in addition to usual GP care. Participants who were randomised to the control group were offered usual GP care. MAIN OUTCOME MEASURES: the primary outcome was depression at 4 months (PHQ-9). Secondary outcomes were depression at 12 and 24 months; measures of mental health and health-related quality of life at 4, 12 and 24 months; treatment preference; and the acceptability of cCBT and experiences of users. RESULTS: Clinical effectiveness: 210 patients were randomised to Beating the Blues, 242 patients were randomised to MoodGYM and 239 patients were randomised to usual GP care (total 691). There was no difference in the primary outcome (depression measured at 4 months) either between Beating the Blues and usual GP care [odds ratio (OR) 1.19, 95% confidence interval (CI) 0.75 to 1.88] or between MoodGYM and usual GP care (OR 0.98, 95% CI 0.62 to 1.56). There was no overall difference across all time points for either intervention compared with usual GP care in a mixed model (Beating the Blues versus usual GP care, p = 0.96; and MoodGYM versus usual GP care, p = 0.11). However, a small but statistically significant difference between MoodGYM and usual GP care at 12 months was found (OR 0.56, 95% CI 0.34 to 0.93). Free-to-use cCBT (MoodGYM) was not inferior to pay-to-use cCBT (Beating the Blues) (OR 0.91, 90% CI 0.62 to 1.34; p = 0.69). There were no consistent benefits of either intervention when secondary outcomes were examined. There were no serious adverse events thought likely to be related to the trial intervention. Despite the provision of regular technical telephone support, there was low uptake of the cCBT programs. Cost-effectiveness: cost-effectiveness analyses suggest that neither Beating the Blues nor MoodGYM appeared cost-effective compared with usual GP care alone. Qualitative evaluation: participants were often demotivated to access the computer programs, by reason of depression. Some expressed the view that a greater level of therapeutic input would be needed to promote engagement. CONCLUSIONS: the benefits that have previously been observed in developer-led trials were not found in this large pragmatic RCT. The benefits of cCBT when added to routine primary care were minimal, and uptake of this mode of therapy was relatively low. There remains a clinical and economic need for effective low-intensity psychological treatments for depression with improved patient engagement. TRIAL REGISTRATION: This trial is registered as ISRCTN91947481. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme.

STUDY QUESTION: How effective is supported computerised cognitive behaviour therapy (cCBT) as an adjunct to usual primary care for adults with depression? METHODS: This was a pragmatic, multicentre, three arm, parallel randomised controlled trial with simple randomisation. Treatment allocation was not blinded. Participants were adults with symptoms of depression (score ≥ 10 on nine item patient health questionnaire, PHQ-9) who were randomised to receive a commercially produced cCBT programme ("Beating the Blues") or a free to use cCBT programme (MoodGYM) in addition to usual GP care. Participants were supported and encouraged to complete the programme via weekly telephone calls. Control participants were offered usual GP care, with no constraints on the range of treatments that could be accessed. The primary outcome was severity of depression assessed with the PHQ-9 at four months. Secondary outcomes included health related quality of life (measured by SF-36) and psychological wellbeing (measured by CORE-OM) at four, 12, and 24 months and depression at 12 and 24 months. STUDY ANSWER AND LIMITATIONS: Participants offered commercial or free to use cCBT experienced no additional improvement in depression compared with usual GP care at four months (odds ratio 1.19 (95% confidence interval 0.75 to 1.88) for Beating the Blues v usual GP care; 0.98 (0.62 to 1.56) for MoodGYM v usual GP care). There was no evidence of an overall difference between either programme compared with usual GP care (0.99 (0.57 to 1.70) and 0.68 (0.42 to 1.10), respectively) at any time point. Commercially provided cCBT conferred no additional benefit over free to use cCBT or usual GP care at any follow-up point. Uptake and use of cCBT was low, despite regular telephone support. Nearly a quarter of participants (24%) had dropped out by four months. The study did not have enough power to detect small differences so these cannot be ruled out. Findings cannot be generalised to cCBT offered with a much higher level of guidance and support. WHAT THIS STUDY ADDS: Supported cCBT does not substantially improve depression outcomes compared with usual GP care alone. In this study, neither a commercially available nor free to use computerised CBT intervention was superior to usual GP care. FUNDING, COMPETING INTERESTS, DATA SHARING: Commissioned and funded by the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project No 06/43/05). The authors have no competing interests. Requests for patient level data will be considered by the REEACT trial management groupTrial registration Current Controlled Trials ISRCTN91947481.

BACKGROUND: the ESTEEM trial was a cluster randomised controlled trial that compared two telephone triage management systems (general practitioner (GP) or a nurse supported by computer decision support software) with usual care, in response to a request for same-day consultation in general practice. AIM: to investigate associations between trial patients' demographic, health, and lifestyle characteristics, and their reported experiences of care. SETTING: Recruitment of 20�
990 patients occurred between May 2011 and December 2012 in 42 GP practices in England (13 GP triage, 15 nurse triage, 14 usual care). METHOD: Patients reported their experiences via a postal questionnaire issued 4�
weeks after their initial request for a same-day consultation. Overall satisfaction, ease of accessing medical help/advice, and convenience of care were analysed using linear hierarchical modelling. RESULTS: Questionnaires were returned by 12�
132 patients (58%). Older patients reported increased overall satisfaction compared with patients aged 25-59�
years, but patients aged 16-24�
years reported lower satisfaction. Compared with white patients, patients from ethnic minorities reported lower satisfaction in all three arms, although to a lesser degree in the GP triage arm. Patients from ethnic minorities reported higher satisfaction in the GP triage than in usual care, whereas white patients reported higher satisfaction with usual care. Patients unable to take time away from work or who could only do so with difficulty reported lower satisfaction across all three trial arms. CONCLUSIONS: Patient characteristics, such as age, ethnicity and ability to attend their practice during work hours, were associated with their experiences of care following a same-day consultation request in general practice. Telephone triage did not increase satisfaction among patients who were unable to attend their practice during working hours. TRIAL REGISTRATION NUMBER: ISCRTN20687662.

BACKGROUND: Telephone triage represents one strategy to manage demand for face-to-face GP appointments in primary care. However, limited evidence exists of the challenges GP practices face in implementing telephone triage. We conducted a qualitative process evaluation alongside a UK-based cluster randomised trial (ESTEEM) which compared the impact of GP-led and nurse-led telephone triage with usual care on primary care workload, cost, patient experience, and safety for patients requesting a same-day GP consultation. The aim of the process study was to provide insights into the observed effects of the ESTEEM trial from the perspectives of staff and patients, and to specify the circumstances under which triage is likely to be successfully implemented. Here we report perspectives of staff. METHODS: the intervention comprised implementation of either GP-led or nurse-led telephone triage for a period of 2-3 months. A qualitative evaluation was conducted using staff interviews recruited from eight general practices (4 GP triage, 4 Nurse triage) in the UK, implementing triage as part of the ESTEEM trial. Qualitative interviews were undertaken with 44 staff members in GP triage and nurse triage practices (16 GPs, 8 nurses, 7 practice managers, 13 administrative staff). RESULTS: Staff reported diverse experiences and perceptions regarding the implementation of telephone triage, its effects on workload, and on the benefits of triage. Such diversity were explained by the different ways triage was organised, the staffing models used to support triage, how the introduction of triage was communicated across practice staff, and by how staff roles were reconfigured as a result of implementing triage. CONCLUSION: the findings from the process evaluation offer insight into the range of ways GP practices participating in ESTEEM implemented telephone triage, and the circumstances under which telephone triage can be successfully implemented beyond the context of a clinical trial. Staff experiences and perceptions of telephone triage are shaped by the way practices communicate with staff, prepare for and sustain the changes required to implement triage effectively, as well as by existing practice culture, and staff and patient behaviour arising in response to the changes made. TRIAL REGISTRATION: Current Controlled Trials ISRCTN20687662. Registered 28 May 2009.

BACKGROUND: Current health and social care systems are providing suboptimal and fragmented care to the growing dementia population. Interventions aiming to coordinate care services for individuals with dementia and their families are already widely used; however, the structure and implementation of these interventions vary. This mixed studies review aims to investigate the key components of effective community-based interventions that focus on coordinating care in dementia. METHODS: We will search MEDLINE, Cochrane Library, Embase and PsycINFO databases for studies of any design that look at community-based interventions that aim to coordinate dementia care through the allocation of a specified professional responsible for provision of care. Health Management Information Consortium (HMIC), Social Policy and Practice (SPP), ProQuest and International Clinical Trials Registry Platform (ICTRP) databases will be searched for grey literature. Outcomes of interest are health outcome measures that relate to the individual with dementia and/or informal caregiver, measures of resource use or process measures. Two independent reviewers will screen identified papers and extract data from eligible studies. Evidence synthesis will take place in three stages, and methods will be largely dependent on the data available. A sequential review design will be used where the qualitative evidence will be synthesised first, focusing on stakeholder's subjective views of key components. This will drive forward the quantitative stage which will identify key components of effective interventions. The final stage of the review will merge the two strands of evidence through a narrative synthesis. DISCUSSION: the results from this review will be used to develop a model for a community-based intervention coordinating care in dementia. Furthermore, the findings will help guide future work on intervention development of health and social care services for dementia. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015024618.

Objective: the main objective of this study was to report the feasibility of delivering online cognitive-behavioral therapy (iCBT) treatments for anxiety and depression in a national public mental health service. Methods: a prospective noncontrolled cohort study was conducted of all patients who began assessment or treatment at the MindSpot Clinic from January through December 2013. Clinic services were used by a representative cross-section of the Australian population. Mean age at assessment was 36.4613.0 years, and age range was 18-86 years. Patients completed one of four online courses over eight weeks, during which they received weekly support from a therapist via telephone or secure e-mail. Primary outcome measures were the nine-item Patient Health Questionnaire (PHQ-9) and the seven-item Generalized Anxiety Disorder scale (GAD-7) administered at posttreatment and three months posttreatment. Results: a total of 10,293 adults who self-identified as having problems with anxiety or depression commenced assessment, and 7,172 completed the assessment and were eligible for analysis. of these, 2,049 enrolled in a course and 1,471 completed the course, for a course completion rate of 71.8%. Moderate to large noncontrolled effect sizes (Cohen's d=.67-1.66, 95% confidence interval=.08-2.07) were found from assessment to three-month follow-up. At posttreatment and follow-up, reliable recovery ranged from 46.7% to 51.1%, and deterioration ranged from 1.9% to 3.8%. Mean total therapist time per patient was 111.8661.6 minutes. Conclusions: the MindSpot Clinic produced treatment outcomes that were comparable to results from published clinical trials of iCBT. This model of service delivery represents an innovative method of providing accessible, low-cost, effective, and acceptable mental health services to many people who currently are not receiving care.

Background in stepped care models patients typically start with a low-intensity evidence-based treatment. Progress is monitored systematically and those patients who do not respond adequately step up to a subsequent treatment of higher intensity. Despite the fact that many guidelines have endorsed this stepped care principle it is not clear if stepped care really delivers similar or better patient outcomes against lower costs compared with other systems. We performed a systematic review and meta-Analysis of all randomized trials on stepped care for depression. Method We carried out a comprehensive literature search. Selection of studies, evaluation of study quality and extraction of data were performed independently by two authors. Results a total of 14 studies were included and 10 were used in the meta-Analyses (4580 patients). All studies used screening to identify possible patients and care as usual as a comparator. Study quality was relatively high. Stepped care had a moderate effect on depression (pooled 6-month between-group effect size Cohen's d was 0.34; 95% confidence interval 0.20-0.48). The stepped care interventions varied greatly in number and duration of treatment steps, treatments offered, professionals involved, and criteria to step up. Conclusions There is currently only limited evidence to suggest that stepped care should be the dominant model of treatment organization. Evidence on (cost-) effectiveness compared with high-intensity psychological therapy alone, as well as with matched care, is required.

INTRODUCTION: in Australia there is an overwhelming need to provide effective treatment to patients presenting to the Emergency Department (ED) in mental health crisis. We adapted Improving Access to Psychological Therapies service model (IAPT) from the National Health Service (NHS) method for the large scale delivery of psychological therapies throughout the United Kingdom to an Australian ED setting. This telephone-based low intensity therapy was provided to people presenting in crisis to the EDs with combinations of anxiety, depression, substance use, and suicidal thinking. METHODS: This uncontrolled study utilised session-by-session, before-and-after measures of anxiety and depression via Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorder-7 (GAD-7). RESULTS: of 347 eligible post-crisis ED referred patients, 291 (83.9%) engaged with the IAPT team. Most patients (65%) had attended the ED previously on an average of 3.9 (SD = 6.0) occasions. Two hundred and forty one patients received an average of 4.1 (SD = 2.3) contacts of low-intensity psychological therapies including 1.2 (SD = 1.7) community outreach visits between 20th Oct 2011 and 31st Dec 2012. Treated patients reported clinically significant improvements in anxiety, depression and suicidal ideation. Uncontrolled effect sizes were moderate for anxiety (0.6) and depression (0.6). DISCUSSION: the Australian ED IAPT program demonstrated that the UK IAPT program could be adapted for emergency mental health patients and be associated with similar clinical benefits as the original program. FUNDING: the Flinders Medical Centre IAPT program received Emergency Department project funding from the Australian Commonwealth Government through the Council of Australian Governments (COAG) and the South Australian Government initiative, Every Patient Every Service (EPES).

BACKGROUND: Telephone triage is proposed as a method of managing increasing demand for primary care. Previous studies have involved small samples in limited settings, and focused on nurse roles. Evidence is limited regarding the impact on primary care workload, costs, and patient safety and experience when triage is used to manage patients requesting same-day consultations in general practice. OBJECTIVES: in comparison with usual care (UC), to assess the impact of GP-led telephone triage (GPT) and nurse-led computer-supported telephone triage (NT) on primary care workload and cost, patient experience of care, and patient safety and health status for patients requesting same-day consultations in general practice. DESIGN: Pragmatic cluster randomised controlled trial, incorporating economic evaluation and qualitative process evaluation. SETTING: General practices (n = 42) in four regions of England, UK (Devon, Bristol/Somerset, Warwickshire/Coventry, Norfolk/Suffolk). PARTICIPANTS: Patients requesting same-day consultations. INTERVENTIONS: Practices were randomised to GPT, NT or UC. Data collection was not blinded; however, analysis was conducted by a statistician blinded to practice allocation. MAIN OUTCOME MEASURES: Primary - primary care contacts [general practice, out-of-hours primary care, accident and emergency (A&E) and walk-in centre attendances] in the 28 days following the index consultation request. Secondary - resource use and costs, patient safety (deaths and emergency hospital admissions within 7 days of index request, and A&E attendance within 28 days), health status and experience of care. RESULTS: of 20,990 eligible randomised patients (UC n = 7283; GPT n = 6695; NT n = 7012), primary outcome data were analysed for 16,211 patients (UC n = 5572; GPT n = 5171; NT n = 5468). Compared with UC, GPT and NT increased primary outcome contacts (over 28-day follow-up) by 33% [rate ratio (RR) 1.33, 95% confidence interval (CI) 1.30 to 1.36] and 48% (RR 1.48, 95% CI 1.44 to 1.52), respectively. Compared with GPT, NT was associated with a marginal increase in primary outcome contacts by 4% (RR 1.04, 95% CI 1.01 to 1.08). Triage was associated with a redistribution of primary care contacts. Although GPT, compared with UC, increased the rate of overall GP contacts (face to face and telephone) over the 28 days by 38% (RR 1.38, 95% CI 1.28 to 1.50), GP face-to-face contacts were reduced by 39% (RR 0.61, 95% CI 0.54 to 0.69). NT reduced the rate of overall GP contacts by 16% (RR 0.84, 95% CI 0.78 to 0.91) and GP face-to-face contacts by 20% (RR 0.80, 95% CI 0.71 to 0.90), whereas nurse contacts increased. The increased rate of primary care contacts in triage arms is largely attributable to increased telephone contacts. Estimated overall patient-clinician contact time on the index day increased in triage (GPT = 10.3 minutes; NT = 14.8 minutes; UC = 9.6 minutes), although patterns of clinician use varied between arms. Taking account of both the pattern and duration of primary outcome contacts, overall costs over the 28-day follow-up were similar in all three arms (approximately £75 per patient). Triage appeared safe, and no differences in patient health status were observed. NT was somewhat less acceptable to patients than GPT or UC. The process evaluation identified the complexity associated with introducing triage but found no consistency across practices about what works and what does not work when implementing it. CONCLUSIONS: Introducing GPT or NT was associated with a redistribution of primary care workload for patients requesting same-day consultations, and at similar cost to UC. Although triage seemed to be safe, investigation of the circumstances of a larger number of deaths or admissions after triage might be warranted, and monitoring of these events is necessary as triage is implemented. TRIAL REGISTRATION: Current Controlled Trials ISRCTN20687662. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 13. See the NIHR Journals Library website for further project information.

There is growing evidence that Behavioural Activation is an effective treatment for older adults with depression. However, there is a lack of detail given in studies about any adaptations made to interventions or efforts made to remove treatment barriers. Factors such as co-morbid physical health problems, cognitive impairment and problems with social support suggest there may be specific treatment considerations when developing interventions for this group. This article aims to describe adaptations made to a general adult Behavioural Activation manual using literature on treatment factors for older adults as an organizational framework. This information may be of use to mental health workers delivering behavioural interventions to older adults with depression and documents the initial phase of developing a complex intervention.

Background: Depression is a common, disabling condition for which psychological treatments are recommended. Behavioural activation has attracted increased interest in recent years. It has been over 5 years since our meta-analyses summarised the evidence supporting and this systematic review updates those findings and examines moderators of treatment effect. Method: Randomised trials of behavioural activation for depression versus controls or anti-depressant medication were identified using electronic database searches, previous reviews and reference lists. Data on symptom level and study level moderators were extracted and analysed using meta-analysis, sub-group analysis and meta-regression respectively. Results: Twenty six randomised controlled trials including 1524 subjects were included in this meta-analysis. A random effects meta-analysis of symptom level post treatment showed behavioural activation to be superior to controls (SMD - 0.74 CI -0.91 to -0.56, k = 25, N = 1088) and medication (SMD -0.42 CI -0.83 to-0.00, k = 4, N = 283). Study quality was low in the majority of studies and follow- up time periods short. There was no indication of publication bias and subgroup analysis showed limited association between moderators and effect size. Conclusions: the results in this meta-analysis support and strengthen the evidence base indicating Behavioural Activation is an effective treatment for depression. Further high quality research with longer term follow-up is needed to strengthen the evidence base. © 2014 Ekers et al.

BACKGROUND: Collaborative care is a complex intervention based on chronic disease management models and is effective in the management of depression. However, there is still uncertainty about which components of collaborative care are effective. We used meta-regression to identify factors in collaborative care associated with improvement in patient outcomes (depressive symptoms) and the process of care (use of anti-depressant medication). METHODS AND FINDINGS: Systematic review with meta-regression. The Cochrane Collaboration Depression, Anxiety and Neurosis Group trials registers were searched from inception to 9th February 2012. An update was run in the CENTRAL trials database on 29th December 2013. Inclusion criteria were: randomised controlled trials of collaborative care for adults ≥18 years with a primary diagnosis of depression or mixed anxiety and depressive disorder. Random effects meta-regression was used to estimate regression coefficients with 95% confidence intervals (CIs) between study level covariates and depressive symptoms and relative risk (95% CI) and anti-depressant use. The association between anti-depressant use and improvement in depression was also explored. Seventy four trials were identified (85 comparisons, across 21,345 participants). Collaborative care that included psychological interventions predicted improvement in depression (β coefficient -0.11, 95% CI -0.20 to -0.01, p = 0.03). Systematic identification of patients (relative risk 1.43, 95% CI 1.12 to 1.81, p = 0.004) and the presence of a chronic physical condition (relative risk 1.32, 95% CI 1.05 to 1.65, p = 0.02) predicted use of anti-depressant medication. CONCLUSION: Trials of collaborative care that included psychological treatment, with or without anti-depressant medication, appeared to improve depression more than those without psychological treatment. Trials that used systematic methods to identify patients with depression and also trials that included patients with a chronic physical condition reported improved use of anti-depressant medication. However, these findings are limited by the observational nature of meta-regression, incomplete data reporting, and the use of study aggregates.

BACKGROUND: Cognitive behaviour therapy (CBT) is an effective treatment for depression. However, CBT is a complex therapy that requires highly trained and qualified practitioners, and its scalability is therefore limited by the costs of training and employing sufficient therapists to meet demand. Behavioural activation (BA) is a psychological treatment for depression that may be an effective alternative to CBT and, because it is simpler, might also be delivered by less highly trained and specialised mental health workers. METHODS/DESIGN: COBRA is a two-arm, non-inferiority, patient-level randomised controlled trial, including clinical, economic, and process evaluations comparing CBT delivered by highly trained professional therapists to BA delivered by junior professional or para-professional mental health workers to establish whether the clinical effectiveness of BA is non-inferior to CBT and if BA is cost effective compared to CBT. Four hundred and forty patients with major depressive disorder will be recruited through screening in primary care. We will analyse for non-inferiority in per-protocol and intention-to-treat populations. Our primary outcome will be severity of depression symptoms (Patient Health Questionnaire-9) at 12 months follow-up. Secondary outcomes will be clinically significant change and severity of depression at 18 months, and anxiety (General Anxiety Disorder-7 questionnaire) and health-related quality of life (Short-Form Health Survey-36) at 12 and 18 months. Our economic evaluation will take the United Kingdom National Health Service/Personal Social Services perspective to include costs of the interventions, health and social care services used, plus productivity losses. Cost-effectiveness will explored in terms of quality-adjusted life years using the EuroQol-5D measure of health-related quality of life. DISCUSSION: the clinical and economic outcomes of this trial will provide the evidence to help policy makers, clinicians and guideline developers decide on the merits of including BA as a first-line treatment of depression. TRIAL REGISTRATION: Current Controlled Trials ISRCTN27473954.

BACKGROUND: Collaborative care is an effective treatment for the management of depression but evidence on its cost-effectiveness in the UK is lacking. AIMS: to assess the cost-effectiveness of collaborative care in a UK primary care setting. METHODS: an economic evaluation alongside a multi-centre cluster randomised controlled trial comparing collaborative care with usual primary care for adults with depression (n = 581). Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICER) were calculated over a 12-month follow-up, from the perspective of the UK National Health Service and Personal Social Services (i.e. Third Party Payer). Sensitivity analyses are reported, and uncertainty is presented using the cost-effectiveness acceptability curve (CEAC) and the cost-effectiveness plane. RESULTS: the collaborative care intervention had a mean cost of £272.50 per participant. Health and social care service use, excluding collaborative care, indicated a similar profile of resource use between collaborative care and usual care participants. Collaborative care offered a mean incremental gain of 0.02 (95% CI: -0.02, 0.06) quality-adjusted life-years over 12 months, at a mean incremental cost of £270.72 (95% CI: -202.98, 886.04), and resulted in an estimated mean cost per QALY of £14,248. Where costs associated with informal care are considered in sensitivity analyses collaborative care is expected to be less costly and more effective, thereby dominating treatment as usual. CONCLUSION: Collaborative care offers health gains at a relatively low cost, and is cost-effective compared with usual care against a decision-maker willingness to pay threshold of £20,000 per QALY gained. Results here support the commissioning of collaborative care in a UK primary care setting.

BACKGROUND: Stepped care is recommended and implemented as a means to organise depression treatment. Compared with alternative systems, it is assumed to achieve equivalent clinical effects and greater efficiency. However, no trials have examined these assumptions. A fully powered trial of stepped care compared with intensive psychological therapy is required but a number of methodological and procedural uncertainties associated with the conduct of a large trial need to be addressed first. METHODS/DESIGN: STEPS (Developing stepped care treatment for depression) is a mixed methods study to address uncertainties associated with a large-scale evaluation of stepped care compared with high-intensity psychological therapy alone for the treatment of depression. We will conduct a pilot randomised controlled trial with an embedded process study. Quantitative trial data on recruitment, retention and the pathway of patients through treatment will be used to assess feasibility. Outcome data on the effects of stepped care compared with high-intensity therapy alone will inform a sample size calculation for a definitive trial. Qualitative interviews will be undertaken to explore what people think of our trial methods and procedures and the stepped care intervention. A minimum of 60 patients with Major Depressive Disorder will be recruited from an Improving Access to Psychological Therapies service and randomly allocated to receive stepped care or intensive psychological therapy alone. All treatments will be delivered at clinic facilities within the University of Exeter. Quantitative patient-related data on depressive symptoms, worry and anxiety and quality of life will be collected at baseline and 6 months. The pilot trial and interviews will be undertaken concurrently. Quantitative and qualitative data will be analysed separately and then integrated. DISCUSSION: the outcomes of this study will inform the design of a fully powered randomised controlled trial to evaluate the effectiveness and efficiency of stepped care. Qualitative data on stepped care will be of immediate interest to patients, clinicians, service managers, policy makers and guideline developers. A more informed understanding of the feasibility of a large trial will be obtained than would be possible from a purely quantitative (or qualitative) design. TRIAL REGISTRATION: Current Controlled Trials ISRCTN66346646 registered on 2 July 2014.

Background: Collaborative care (CC) is an organisational framework which facilitates the delivery of a mental health intervention to patients by case managers in collaboration with more senior health professionals (supervisors and GPs), and is effective for the management of depression in primary care. However, there remains limited evidence on how to successfully implement this collaborative approach in UK primary care. This study aimed to explore to what extent CC impacts on professional working relationships, and if CC for depression could be implemented as routine in the primary care setting.
Methods: This qualitative study explored perspectives of the 6 case managers (CMs), 5 supervisors (trial research team members) and 15 general practitioners (GPs) from practices participating in a randomised controlled trial of CC for depression. Interviews were transcribed verbatim and data was analysed using a two-step approach using an initial thematic analysis, and a secondary analysis using the Normalisation Process Theory concepts of coherence, cognitive participation, collective action and reflexive monitoring with respect to the implementation of CC in primary care.
Results: Supervisors and CMs demonstrated coherence in their understanding of CC, and consequently reported good levels of cognitive participation and collective action regarding delivering and supervising the intervention. GPs interviewed showed limited understanding of the CC framework, and reported limited collaboration with CMs: barriers to collaboration were identified. All participants identified the potential or experienced benefits of a collaborative approach to depression management and were able to discuss ways in which collaboration can be facilitated.
Conclusion: Primary care professionals in this study valued the potential for collaboration, but GPs’ understanding of CC and organisational barriers hindered opportunities for communication. Further work is needed to address these organisational barriers in order to facilitate collaboration around individual patients with depression, including shared IT systems, facilitating opportunities for informal discussion and building in formal collaboration into the CC framework.
Trial registration: ISRCTN32829227 30/9/2008.

Background. Despite the high prevalence of postnatal depression (PND), few women seek help. Internet interventions
may overcome many of the barriers to PND treatment use. We report a phase II evaluation of a 12-session, modular,
guided Internet behavioural activation (BA) treatment modified to address postnatal-specific concerns [Netmums
Helping with Depression (NetmumsHWD)].
Method. To assess feasibility, we measured recruitment and attrition to the trial and examined telephone session support
and treatment adherence. We investigated sociodemographic and psychological predictors of treatment adherence.
Effectiveness outcomes were estimated with the Edinburgh Postnatal Depression Scale (EPDS), Generalized Anxiety
Disorder-7, Work and Social Adjustment Scale, Postnatal Bonding Questionnaire, and Social Provisions Scale.
Results. A total of 249 women were recruited via a UK parenting site, Netmums.com. A total of 83 women meeting
DSM-IV criteria for major depressive disorder were randomized to NetmumsHWD (n=41) or treatment-as-usual
(TAU; n=42). of the 83 women, 71 (86%) completed the EPDS at post-treatment, and 71% (59/83) at the 6-month
follow-up. Women completed an average of eight out of 12 telephone support sessions and five out of 12 modules.
Working women and those with less support completed fewer modules. There was a large effect size favouring
women who received NetmumsHWD on depression, work and social impairment, and anxiety scores at post-treatment
compared with women in the TAU group, and a large effect size on depression at 6 months post-treatment. There were
small effect sizes for postnatal bonding and perceived social support.
Conclusions. A supported, modular, Internet BA programme can be feasibly delivered to postpartum women, offering
promise to improve depression, anxiety and functioning.

BackgroundDespite the high prevalence of postnatal depression (PND), few women seek help. Internet interventions may overcome many of the barriers to PND treatment use. We report a phase II evaluation of a 12-session, modular, guided Internet behavioural activation (BA) treatment modified to address postnatal-specific concerns [Netmums Helping with Depression (NetmumsHWD)].MethodTo assess feasibility, we measured recruitment and attrition to the trial and examined telephone session support and treatment adherence. We investigated sociodemographic and psychological predictors of treatment adherence. Effectiveness outcomes were estimated with the Edinburgh Postnatal Depression Scale (EPDS), Generalized Anxiety Disorder-7, Work and Social Adjustment Scale, Postnatal Bonding Questionnaire, and Social Provisions Scale.ResultsA total of 249 women were recruited via a UK parenting site, Netmums.com. A total of 83 women meeting DSM-IV criteria for major depressive disorder were randomized to NetmumsHWD (n = 41) or treatment-as-usual (TAU; n = 42). of the 83 women, 71 (86%) completed the EPDS at post-treatment, and 71% (59/83) at the 6-month follow-up. Women completed an average of eight out of 12 telephone support sessions and five out of 12 modules. Working women and those with less support completed fewer modules. There was a large effect size favouring women who received NetmumsHWD on depression, work and social impairment, and anxiety scores at post-treatment compared with women in the TAU group, and a large effect size on depression at 6 months post-treatment. There were small effect sizes for postnatal bonding and perceived social support.ConclusionsA supported, modular, Internet BA programme can be feasibly delivered to postpartum women, offering promise to improve depression, anxiety and functioning.

Sudden gains have been linked to improved outcomes in cognitive behaviour therapy for depression. The relationship between sudden gains and outcome is less clear in other treatment modalities, including interpersonal psychotherapy and supportive expressive therapy, which may indicate different mechanisms of change between treatment modalities. The current study examined sudden gains in adults meeting diagnostic criteria for depression ( N=40) offered up to 12 sessions of behavioural activation treatment. Sudden gains were found in 42.5% of the sample. Sudden gains occurred early (median pre-gain session 2) and were related to outcome: those who experienced a sudden gain had significantly lower post-treatment scores on the PHQ-9. Furthermore, the proportion meeting the reliable and clinically significant change criteria at end of treatment was higher in the sudden gain group. These findings highlight the importance of understanding the mechanisms by which sudden gains relate to therapy outcome in behavioural activation. © 2014 Elsevier Ltd.

Background

Increased life expectancy has resulted in a greater provision of informal care within the community for patients with chronic physical health conditions. Informal carers are at greater risk of poor mental health, with one in three informal carers of stroke survivors experiencing depression. However, currently no psychological treatments tailored to the unique needs of depressed informal carers of stroke survivors exist. Furthermore, informal carers of stroke survivors experience a number of barriers to attending traditional face-to-face psychological services, such as lack of time and the demands of the caring role. The increased flexibility associated with supported cognitive behavioral therapy self-help (CBTsh), such as the ability for support to be provided by telephone, email, or face-to-face, alongside shorter support sessions, may help overcome such barriers to access. CBTsh, tailored to depressed informal carers of stroke survivors may represent an effective and acceptable solution.
Methods

This study is a Phase II (feasibility) randomized controlled trial (RCT) following guidance in the MRC Complex Interventions Research Methods Framework. We will randomize a sample of depressed informal carers of stroke survivors to receive CBT self-help supported by mental health paraprofessionals, or treatment-as-usual. Consistent with the objectives of assessing the feasibility of trial design and procedures for a potential larger scale trial we will measure the following outcomes: a) feasibility of patient recruitment (recruitment and refusal rates); (b) feasibility and acceptability of data collection procedures; (c) levels of attrition; (d) likely intervention effect size; (e) variability in number, length and frequency of support sessions estimated to bring about recovery; and (f) acceptability of the intervention. Additionally, we will collect data on the diagnosis of depression, symptoms of depression and anxiety, functional impairment, carer burden, quality of life, and stroke survivor mobility skill, self-care and functional ability, measured at four and six months post-randomization.
Discussion

This study will provide important information for the feasibility and design of a Phase III (effectiveness) trial in the future. If the intervention is identified to be feasible, effective, and acceptable, a written CBTsh intervention for informal carers of stroke survivors, supported by mental health paraprofessionals, could represent a cost-effective model of care.

Trial registration: Current Controlled Trials ISRCTN63590486.

Background: the 'cohort multiple Randomised Controlled Trial' (cmRCT) design has been proposed as a potential solution to poor recruitment into clinical trials. The design randomly selects participants eligible for experimental treatments from a pre-enrolled cohort of patients, recruiting participants to multiple trials from a single cohort. Controls remain unaware of their participation in specific trials. Methods: We undertook a mixed methods study to determine the ethical acceptability, the proportion of patients in a routine service consenting to cohort participation, the proportion of these who would consent to being hypothetically randomly selected to receive new treatments, and the views of clinicians on the acceptability of the design. We submitted our cmRCT design for ethical review and recruited participants from people with anxiety and depression attending a community mental health service of twenty-one clinicians. We recorded the proportion of patients who were offered participation in the DiReCT study and the proportion that consented to researcher contact, medical record sharing, and who accepted to be randomly allocated to active treatment procedures in future hypothetical unspecified clinical trials. We used a thematic framework analysis to analyse clinician interviews. Results: We obtained a favourable ethical opinion from the UK Health Research Authority. Clinicians approached 131/752 (17%) potentially eligible participants for consent. of these 131, 84 (64%) initially consented to be contacted by a researcher and all but one consented to being randomised into future trials. We confirmed consent for 71 (54%) of participants approached by clinicians, of whom 69 (53%) consented to being randomised into hypothetical future trials, 9% (69/752) of all potentially eligible patients. The interviewed clinicians described issues impacting on their ability to recruit participants in terms of clinical concerns for patient wellbeing, work pressure, their views of both general research and the specific DiReCT study, and how they viewed patients' responses to being offered participation in the study. Conclusions: the cmRCT system offers the potential to improve the recruitment into clinical trials and is acceptable ethically and to many patients. Overcoming the multiple factors driving the difficulties clinicians experience in patient recruitment is likely to require the application of significant implementation science-informed effort.

Background: Reviews of nursing research have suggested that most is descriptive; with no more than 15% providing strong evidence for practice. No studies have examined this from the perspective of nursing research conducted in Europe.

Objective: the aim of this study was to review reports of European clinical nursing research in the top 20 nursing journals in 2010 to establish a baseline of nursing research activity in the year immediately prior to the launch of a European Science Foundation network to increase the proportion of intervention research in Europe.

Methods: We identified eligible reports that were then data-extracted by two independent reviewers. Disagreements were resolved through pair discussion and independent arbitration. We appraised and synthesized topics, methods, and the extent to which studies were programmatic. We synthesized data as proportions of study reports meeting our a priori categorization criteria.

Results: We identified 1995 published reports and included 223 from 21 European countries, of which 193 (86.6%) reported studies of primary research only, 30 (13.5%) secondary research, and three (1.4%) a mix of primary and secondary. Methodological description was often poor, misleading, or even absent. One hundred (44.8%) articles reported observational studies, 87 (39.0%) qualitative studies. We found 26 (11.7%) articles reporting experimental studies, 10 (4.5%) of which were randomized controlled trials. We found 29 (13.0%) reports located within a larger program of research. Seventy-six (34.1%) articles reported studies of nursing interventions.

Linking Evidence to Action: European research in nursing reported in the leading nursing journals remains descriptive and poorly described. Only a third of research reports concerned nursing interventions, and a tiny proportion were part of a programmatic endeavor. Researchers in nursing must become better educated and skilled in developing, testing, evaluating, and reporting complex nursing interventions. Editors of nursing journals should insist on systematic reporting of research designs and methods in published articles

OBJECTIVE: to compare the clinical effectiveness of collaborative care with usual care in the management of patients with moderate to severe depression. DESIGN: Cluster randomised controlled trial. SETTING: 51 primary care practices in three primary care districts in the United Kingdom. PARTICIPANTS: 581 adults aged 18 years and older who met ICD-10 (international classification of diseases, 10th revision) criteria for a depressive episode on the revised Clinical Interview Schedule. We excluded acutely suicidal patients and those with psychosis, or with type I or type II bipolar disorder; patients whose low mood was associated with bereavement or whose primary presenting problem was alcohol or drug abuse; and patients receiving psychological treatment for their depression by specialist mental health services. We identified potentially eligible participants by searching computerised case records in general practices for patients with depression. INTERVENTIONS: Collaborative care, including depression education, drug management, behavioural activation, relapse prevention, and primary care liaison, was delivered by care managers. Collaborative care involved six to 12 contacts with participants over 14 weeks, supervised by mental health specialists. Usual care was family doctors' standard clinical practice. MAIN OUTCOME MEASURES: Depression symptoms (patient health questionnaire 9; PHQ-9), anxiety (generalised anxiety disorder 7; GAD-7), and quality of life (short form 36 questionnaire; SF-36) at four and 12 months; satisfaction with service quality (client satisfaction questionnaire; CSQ-8) at four months. RESULTS: 276 participants were allocated to collaborative care and 305 allocated to usual care. At four months, mean depression score was 11.1 (standard deviation 7.3) for the collaborative care group and 12.7 (6.8) for the usual care group. After adjustment for baseline depression, mean depression score was 1.33 PHQ-9 points lower (95% confidence interval 0.35 to 2.31, P=0.009) in participants receiving collaborative care than in those receiving usual care at four months, and 1.36 points lower (0.07 to 2.64, P=0.04) at 12 months. Quality of mental health but not physical health was significantly better for collaborative care than for usual care at four months, but not 12 months. Anxiety did not differ between groups. Participants receiving collaborative care were significantly more satisfied with treatment than those receiving usual care. The number needed to treat for one patient to drop below the accepted diagnostic threshold for depression on the PHQ-9 was 8.4 immediately after treatment, and 6.5 at 12 months. CONCLUSIONS: Collaborative care has persistent positive effects up to 12 months after initiation of the intervention and is preferred by patients over usual care. TRIAL REGISTRATION NUMBER: ISRCTN32829227.

Objective to assess how initial severity of depression affects the benefit derived from low intensity interventions for depression. Design Meta-analysis of individual patient data from 16 datasets comparing low intensity interventions with usual care. Setting Primary care and community settings. Participants 2470 patients with depression. Interventions Low intensity interventions for depression (such as guided self help by means of written materials and limited professional support, and internet delivered interventions). Main outcome measures Depression outcomes (measured with the Beck Depression Inventory or Center for Epidemiologic Studies Depression Scale), and the effect of initial depression severity on the effects of low intensity interventions. Results Although patients were referred for low intensity interventions, many had moderate to severe depression at baseline. We found a significant interaction between baseline severity and treatment effect (coefficient -0.1 (95% CI -0.19 to -0.002)), suggesting that patients who are more severely depressed at baseline demonstrate larger treatment effects than those who are less severely depressed. However, the magnitude of the interaction (equivalent to an additional drop of around one point on the Beck Depression Inventory for a one standard deviation increase in initial severity) was small and may not be clinically significant. Conclusions the data suggest that patients with more severe depression at baseline show at least as much clinical benefit from low intensity interventions as less severely depressed patients and could usefully be offered these interventions as part of a stepped care model.

BACKGROUND: Despite the high prevalence of postnatal depression (PND), few women seek help. The internet may increase timely access to treatment. We report a randomized controlled trial of a minimal intervention internet Behavioral Activation (iBA) treatment modified to address postnatal specific concerns (Postnatal-iBA). METHODS: Women (n=910) recruited via a popular UK parenting site, Netmums.com, scoring above 12 on the Edinburgh Postnatal Depression Scale (EPDS) were randomly assigned to receive either Postnatal-iBA delivered or treatment-as-usual (TAU). We investigated the feasibility (recruitment, trial and treatment adherence) and effectiveness (depression status EPDS >12) of the intervention. RESULTS: Recruitment was excellent; 1261 women, 961 of whom met inclusion criteria, signed up to the trial within two 2-week recruitment periods. Thirty-eight percent (343/910) of women completed the 15-week outcome assessment. of those who completed 15-week assessment, fewer exceeded the depression cutoff in the Postnatal-iBA group (n=66/181) compared to TAU (n=91/162). Assuming all non-respondents remained depressed, the Postnatal-iBA effect was reduced. LIMITATIONS: the study suffered from high attrition and future trials need to consider strategies for improving outcome completion. Some women reported struggles "keeping up" with the treatment. CONCLUSIONS: a minimal support, widely accessible internet Behavioral Activation program for PND is feasible to deliver to community populations when embedded within popular parenting sites. For women who provide outcome data, postnatal-iBA offers promise as an effective treatment for PND. The addition of support may reduce women's struggles to keep pace with the treatment.

We describe a modelling toolkit that was developed with the aim of assisting those responsible for introducing stepped care systems to local mental health services in the UK. The toolkit was pre-populated with real patient flow data collected from four sites that piloted the stepped care system design. Two analytical models were developed and coded as part of the toolkit to provide insights concerning workload, patient throughput, and changes in waiting times and waiting list size. An interface was built to allow users to specify their own stepped care system and input their own estimates or data of service demands and capacities at different steps. Despite the challenges and limitations, the use of modelling to inform the design of new service configurations is an important step in the right direction and we would recommend this as a reasonable way forward. © 2013 Operational Research Society Ltd.

We provide a meta-analysis of the empirical literature concerning role breadth, defined as the degree to which employees consider organizational citizenship behavior (OCB) to be an inherent part of their job. Results based on a combined sample size of 9,222 showed: (a) Confucian Asians consider OCB as part of their job to a greater extent than do their Anglo counterparts; (b) affiliative kinds of OCB (e.g. helping, conscientiousness, and courtesy) are more likely to be considered part of one's job than are change-oriented OCB (e.g. voice, taking charge, and initiative); and (c) OCB-inclusive role breadth correlates strongly with OCB (rc =. 43). The implications of these findings for human resources practice, such as competency modeling, employee selection and training, organizational rewards, and employee-employer/supervisor relations, are discussed. © 2013 Wiley Periodicals, Inc.

BACKGROUND: Improved life expectancy is resulting in increased outpatient treatment of people with chronic physical health conditions and reliance on the provision of informal care in the community. However, informal care is also associated with increased risk of experiencing common mental health difficulties such as depression and anxiety. Currently there is a lack of evidence-based treatments for such difficulties, resulting in poor health outcomes for both the informal carer and care recipient. METHODS/DESIGN: Electronic databases will be systemically searched for randomised controlled trials examining the effectiveness of psychological interventions targeted at treating depression or anxiety experienced by informal carers of patients with chronic physical health conditions. Database searches will be supplemented by contact with experts, reference and citation checking and grey literature. Both published and unpublished research in English language will be reviewed with no limitations on year or source. Individual, group and patient-carer dyad focused interventions will be eligible. Primary outcomes of interest will be validated self-report or clinician administered measures of depression or anxiety. If data allows a meta-analysis will examine: (1) the overall effectiveness of psychological interventions in relation to outcomes of depression or anxiety; (2) intervention components associated with effectiveness. DISCUSSION: This review will provide evidence on the effectiveness of psychological interventions for depression and anxiety experienced by informal carers of patients with chronic physical health conditions. In addition, it will examine intervention components associated with effectiveness. Results will inform the design and development of a psychological intervention for carers of people with chronic physical health conditions experiencing depression and anxiety. PROSPERO registration number: CRD42012003114.

Background: There is a need for a generic, short, and easy-to-use assessment measure for common presentations of psychological distress in UK primary care mental health settings. This paper sets out the development of the CORE-10 in response to this need. Method: Items were drawn from the CORE-OM and 10 items were selected according to a combination of usefulness, coverage of item clusters, and statistical procedures. Three CORE-OM datasets were employed in the development phase: (1) a primary care sample, (2) a sample from an MRC platform trial of enhanced collaborative care of depression in primary care, and (3) a general population sample derived from the Office of National Statistics Psychiatric Morbidity Follow-up survey. A fourth dataset comprising a sample from an occupational health setting was used to evaluate the CORE-10 in its standalone format. Results: the internal reliability (alpha) of the CORE-10 was.90 and the score for the CORE-10 correlated with the CORE-OM at.94 in a clinical sample and.92 in a non-clinical sample. The clinical cut-off score for general psychological distress was 11.0 with a reliable change index (90% CI) of 6. For depression, the cut-off score for the CORE-10 was 13 and yielded sensitivity and specificity values of.92 (CI=.83-1.0) and 0.72 (CI=.60-.83) respectively. Conclusion: the CORE-10 is an acceptable and feasible instrument that has good psychometric properties and is practical to use with people presenting with common mental health problems in primary care settings. © 2013 Copyright British Association for Counselling and Psychotherapy.

BACKGROUND: Recent years have seen an increase in primary care workload, especially following the introduction of a new General Medical Services contract in 2004. Telephone triage and telephone consultation with patients seeking health care represent initiatives aimed at improving access to care. Some evidence suggests that such approaches may be feasible but conclusions regarding GP workload, cost, and patients' experience of care, safety, and health status are equivocal. The ESTEEM trial aims to assess the clinical- and cost-effectiveness of nurse-led computer-supported telephone triage and GP-led telephone triage, compared to usual care, for patients requesting same-day consultations in general practice. METHODS/DESIGN: ESTEEM is a pragmatic, multi-centre cluster randomised clinical trial with patients randomised at practice level to usual care, computer decision-supported nurse triage, or GP-led triage. Following triage of 350-550 patients per practice we anticipate estimating and comparing total primary care workload (volume and time), the economic cost to the NHS, and patient experience of care, safety, and health status in the 4-week period following the index same-day consultation request across the three trial conditions.We will recruit all patients seeking a non-emergency same-day appointment in primary care. Patients aged 12.0-15.9 years and temporary residents will be excluded from the study.The primary outcome is the number of healthcare contacts taking place in the 4-week period following (and including) the index same-day consultation request. A range of secondary outcomes will be examined including patient flow, primary care NHS resource use, patients' experience of care, safety, and health status.The estimated sample size required is 3,751 patients (11,253 total) in each of the three trial conditions, to detect a mean difference of 0.36 consultations per patient in the four week follow-up period between either intervention group and usual care 90% power, 5% alpha, and an estimated intracluster correlation coefficient ICC of 0.05. The primary analysis will be based on the intention-to-treat principle and take the form of a random effects regression analysis taking account of the hierarchical nature of the study design. Statistical models will allow for adjustment for practice level minimisation variables and patient-level baseline covariates shown to differ at baseline. TRIAL REGISTRATION: Current Controlled Trials ISCRTN20687662.

The design and implementation of new configurations of mental health services to meet
local needs is a challenging problem. In the UK, services for common mental health
disorders such as anxiety and depression are an example of a system running near or at
capacity, in that it is extremely rare for the queue size for any given mode of treatment to
fall to zero. In this paper we describe a mathematical model that can be applied in such
circumstances. The model provides a simple way of estimating the mean and variance of
the number of patients that would be treated within a given period of time given a
particular configuration of services as defined by the number of appointments allocated to
different modes of treatment and the referral patterns to and between different modes of
treatment.
The model has been used by service planners to explore the impact of different options
on throughput, clinical outcomes, queue sizes and waiting times. We also discuss the
potential for using the model in conjunction with optimisation techniques to inform
service design and its applicability to other contexts.

The current study draws on attachment theory (Bowlby, 1982) to examine how attachment (a relationship-based trait disposition), and the interaction between attachment and emotion regulation, relate to LMX quality. Data were collected from subordinates and supervisors in a variety of work settings. Attachment anxiety and attachment avoidance negatively predicted LMX quality. Moderator effects were found between attachment and emotion regulation. © 2012 Elsevier Inc.

BACKGROUND: Common mental health problems, such as depression and anxiety, are estimated to affect up to 15% of the UK population at any one time, and health care systems worldwide need to implement interventions to reduce the impact and burden of these conditions. Collaborative care is a complex intervention based on chronic disease management models that may be effective in the management of these common mental health problems. OBJECTIVES: to assess the effectiveness of collaborative care for patients with depression or anxiety. SEARCH METHODS: We searched the following databases to February 2012: the Cochrane Collaboration Depression, Anxiety and Neurosis Group (CCDAN) trials registers (CCDANCTR-References and CCDANCTR-Studies) which include relevant randomised controlled trials (RCTs) from MEDLINE (1950 to present), EMBASE (1974 to present), PsycINFO (1967 to present) and the Cochrane Central Register of Controlled Trials (CENTRAL, all years); the World Health Organization (WHO) trials portal (ICTRP); ClinicalTrials.gov; and CINAHL (to November 2010 only). We screened the reference lists of reports of all included studies and published systematic reviews for reports of additional studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) of collaborative care for participants of all ages with depression or anxiety. DATA COLLECTION AND ANALYSIS: Two independent researchers extracted data using a standardised data extraction sheet. Two independent researchers made 'Risk of bias' assessments using criteria from the Cochrane Collaboration. We combined continuous measures of outcome using standardised mean differences (SMDs) with 95% confidence intervals (CIs). We combined dichotomous measures using risk ratios (RRs) with 95% CIs. Sensitivity analyses tested the robustness of the results. MAIN RESULTS: We included seventy-nine RCTs (including 90 relevant comparisons) involving 24,308 participants in the review. Studies varied in terms of risk of bias.The results of primary analyses demonstrated significantly greater improvement in depression outcomes for adults with depression treated with the collaborative care model in the short-term (SMD -0.34, 95% CI -0.41 to -0.27; RR 1.32, 95% CI 1.22 to 1.43), medium-term (SMD -0.28, 95% CI -0.41 to -0.15; RR 1.31, 95% CI 1.17 to 1.48), and long-term (SMD -0.35, 95% CI -0.46 to -0.24; RR 1.29, 95% CI 1.18 to 1.41). However, these significant benefits were not demonstrated into the very long-term (RR 1.12, 95% CI 0.98 to 1.27).The results also demonstrated significantly greater improvement in anxiety outcomes for adults with anxiety treated with the collaborative care model in the short-term (SMD -0.30, 95% CI -0.44 to -0.17; RR 1.50, 95% CI 1.21 to 1.87), medium-term (SMD -0.33, 95% CI -0.47 to -0.19; RR 1.41, 95% CI 1.18 to 1.69), and long-term (SMD -0.20, 95% CI -0.34 to -0.06; RR 1.26, 95% CI 1.11 to 1.42). No comparisons examined the effects of the intervention on anxiety outcomes in the very long-term.There was evidence of benefit in secondary outcomes including medication use, mental health quality of life, and patient satisfaction, although there was less evidence of benefit in physical quality of life. AUTHORS' CONCLUSIONS: Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Objectives. Computerized cognitive behavioural therapy (cCBT) for depression has a growing evidence base, and is recommended as a treatment choice for depression in recent National Institute for Health and Clinical Excellence (NICE, 2009) guidelines to health services in England and Wales. cCBT programs are designed to translate the evidence-based tasks and techniques of CBT into an accessible, multimedia format, but it is less clear whether they also translate critical common factors of therapy, which may be necessary for engagement and associated with therapeutic outcomes. This study investigates whether and to what extent three widely used cCBT programs for depression incorporate and convey key features that serve to establish, develop, and maintain a therapeutic alliance with program users. Design. This study adopted a qualitative approach to develop a thematic framework of alliance features specific to cCBT. Method. Three online cCBT programs designed to treat mild-to-moderate depression were investigated for alliance-related themes and sub-themes. Results. The analysis revealed substantial evidence of therapeutic alliance features across the sample of cCBT programs, the prevalence and quality of which varied across relational stages. Conclusions. cCBT programs build on traditional self-help tools, offering unique relational features. Findings raise theoretical implications, in addition to guidance for future cCBT program development and service provision. ©2012 the British Psychological Society.

Background
In the United Kingdom, clinical guidelines recommend that services for depression and anxiety should be structured around a stepped care model, where patients receive treatment at different 'steps,' with the intensity of treatment (i.e. the amount and type) increasing at each step if they fail to benefit at previous steps. There are very limited data available on the implementation of this model, particularly on the intensity of psychological treatment at each step. Our objective was to describe patient pathways through stepped care services and the impact of this on patient flow and management.
Methods
We recorded service design features of four National Health Service sites implementing stepped care (e.g. the types of treatments available and their links with other treatments), together with the actual treatments received by individual patients and their transitions between different treatment steps. We computed the proportions of patients accessing, receiving, and transiting between the various steps and mapped these proportions visually to illustrate patient movement.
Results
We collected throughput data on 7,698 patients referred. Patient pathways were highly complex and very variable within and between sites. The ratio of low (e.g. self-help) to high-intensity (e.g. cognitive behaviour therapy) treatments delivered varied between sites from 22:1, through 2.1:1, 1.4:1 to 0.5:1. The numbers of patients allocated directly to high-intensity treatment varied from 3% to 45%. Rates of stepping up from low-intensity treatment to high-intensity treatment were less than 10%.
Conclusions
When services attempt to implement the recommendation for stepped care in the National Institute for Health and Clinical Excellence guidelines, there were significant differences in implementation and consequent high levels of variation in patient pathways. Evaluations driven by the principles of implementation science (such as targeted planning, defined implementation strategies, and clear activity specification around service organisation) are required to improve evidence on the most effective, efficient, and acceptable stepped care systems.

Objective: to introduce stepped care as a method of organizing the delivery of treatments, and to consider the factors necessary for implementation.
Method: Stepped care is described within the context of strategies such as collaborative care that aim to increase access to mental health care through the improved coordination of care between primary and specialist mental health services. Results from the implementation of stepped care in the United Kingdom and elsewhere are used to highlight the factors required for introducing stepped care into routine services. Issues to address when implementing high-volume services for common mental health problems are derived from this experience.
Results: Stepped care sits within the continuum of organizational systems, from situations where responsibility rests almost entirely with primary care clinicians to systems where all patients are managed by specialists for the entire duration of their treatment. Its core principles of delivering low-burden treatments first, followed by careful patient progress monitoring to step patients up to more intensive treatment, are easy to articulate but lead to considerable implementation diversity when services attempt to work in this manner. Services need to ensure they have specific staff competency training, including skills in delivering evidence-based treatments, access to telephony, and smart patient management informatics systems.
Conclusions: Stepped care can provide the delivery system for supported selfmanagement. To be successful, health systems need high levels of clinical outcome data and appropriately trained workers. Further attention is required to ensure equity of access and to reduce patient attrition in these systems.

Background
Depression accounts for the greatest burden of disease among all mental health problems, and is expected to become the second-highest amongst all general health problems by 2020. By the age of 75, 1 in 7 older people meet formal diagnostic criteria for depression. Efforts to ameliorate the burden of illness and personal suffering associated with depression in older people have focussed on those with more severe depressive syndromes. Less attention has been paid to those with mild disorders/sub-threshold depressive syndromes but these patients also suffer impairments in their quality of life and level of functioning.
Methods
The CASPER study has been designed to assemble an epidemiological cohort of people over 75 years of age (the CASPER cohort), from which we will identify those eligible to participate in a trial of collaborative care for sub-threshold depression (the CASPER trial). We aim to undertake a pragmatic randomised controlled multi-centre trial evaluating the effectiveness and cost-effectiveness of collaborative care; a low intensity psychological intervention in addition to usual general practitioner care versus usual general practitioner care alone. General practitioners from practices based in the North of England will be asked to identify potentially eligible patients over the age of 75 years. Patients will be sent a letter inviting them to participate in the study. We aim to recruit approximately 540 participants for the CASPER trial. A diagnostic interview will be carried out to ascertain trial eligibility with the major depressive episode module of the Mini International Neuropsychiatric Interview (M.I.N.I.), eligible participants randomised to either the intervention or usual care. The primary outcome will be measured with the Patient Health Questionnaire-9 (PHQ-9) and additional quality of life measures will be collected. Data will be collected at baseline, 4 and 12 months for both trial and cohort participants.

BACKGROUND: Behavioural activation appears as effective as cognitive-behaviour therapy (CBT) in the treatment of depression. If equally effective, then behavioural activation may be the preferred treatment option because it may be suitable for delivery by therapists with less training. This is the first randomised controlled trial to look at this possibility. AIMS: to examine whether generic mental health workers can deliver effective behavioural activation as a step-three high-intensity intervention. METHOD: a randomised controlled trial (ISRCTN27045243) comparing behavioural activation (n=24) with treatment as usual (n=23) in primary care. RESULTS: Intention-to-treat analyses indicated a difference in favour of behavioural activation of -15.79 (95% CI -24.55 to -7.02) on the Beck Depression Inventory-II and Work and Social Adjustment Scale (mean difference -11.12, 95% CI -17.53 to -4.70). CONCLUSIONS: Effective behavioural activation appears suitable for delivery by generic mental health professionals without previous experience as therapists. Large-scale trial comparisons with an active comparator (CBT) are needed.

In this Editorial we urge researchers in nursing to increase the volume of translational research. by embracing new complex interventions research methods thinking. We introduce readers to a multi-state strategy, supported by eight European research funding bodies, which aims to develop an international nursing research faculty. This faculty will be equipped to design, plan and implement programmatic, mixed methods and complex interventions research in nursing. The aim of this strategy – the REFLECTION Research Network Programme – is to inculcate ‘complex intervention thinking’ in both experienced and the next generation of researchers in nursing.

Behavioural activation by non-specialists appears effective in the treatment of depression. We examined incremental cost effectiveness of behavioural activation (n = 24) v. treatment as usual (n = 23) in a randomised controlled trial. Intention to treat analyses indicated a quality-adjusted life-year (QALY)
difference in favour of behavioural activation of 0.20 (95% CI 0.01–0.39, P = 0.042), incremental cost-effectiveness ratio of £5756 per QALY and a 97% probability that behavioural
activation is more cost-effective at a threshold value of £20 000. Results are promising for dissemination of behavioural activation but require replication in a larger study.

The recently published guidelines for the practice of outpatient Morita therapy indicate the importance of therapists evaluating the outcomes of their treatment. However, there has been no consensus among Morita therapy researchers on the domains which should be measured and the instruments required. The primary objective of the current study was to identify outcome domains which could be measured to determine the clinical effectiveness of Morita therapy in a range of clinical settings. A formal evidenced-based method of developing consensus using structured group interactions – the ‘constituency approach’ – was used to help participants come to an agreement on suitable outcome domains for measuring the effectiveness of Morita therapy. Twelve participants developed consensus on four areas of measurement: (1) attitude in terms of (a) the relationship with self, (b) affective, cognitive, and physical symptoms, and (c) arugamama and toraware; (2) action in terms of (a) frequency and duration of behaviours associated with constructive action, (b) the desire for life, and (c) the achievement of patient-centred goals; (3) symptoms of mental distress; and (4) satisfaction with, and quality of, life. This consensus process developed a conceptual map of the outcome domains required to assess the effectiveness of Morita therapy. Two tasks to be undertaken in the future are: (a) to identify a standard set of measures which can be used by all Morita therapists in their work, and (b) to gain agreement among members of the Morita therapy community to use these measures in their routine work.

Improving access to psychological treatments for common
mental disorders is a priority in a number of countries
worldwide. We consider the evidence presented by Harris
et al on the Australian Better Access initiative, and discuss
the challenges of delivering such intitiatives and evaluating
their impact.

BACKGROUND: Although the PHQ-9 is widely used in primary care, little is known about its performance in quantifying improvement. The original validation study of the PHQ-9 defined clinically significant change as a post-treatment score of ≤9 combined with improvement of 50%, but it is unclear how this relates to other theoretically informed methods of defining successful outcome. We compared a range of definitions of clinically significant change (original definition, asymptomatic criterion, reliable and clinically significant change criteria a, b and c) in a clinical trial of a community-level depression intervention. METHOD: Randomised Control Trial of collaborative care for depression. Levels of agreement were calculated between the standard definition, other definitions, and gold-standard diagnostic interview. RESULTS: the standard definition showed good agreement (kappa>0.60) with the other definitions and had moderate, though acceptable, agreement with the diagnostic interview (kappa=0.58). The standard definition corresponded closely to reliable and clinically significant change criterion c, the recommended method of quantifying improvement when clinical and non-clinical distributions overlap. LIMITATIONS: the absence of follow-up data meant that an asymptomatic criterion rather than remission or recovery criteria were used. CONCLUSION: the close agreement between the standard definition and reliable and clinically significant change criterion c provides some support for the standard definition of improvement. However, it may be preferable to use a reliable change index rather than 50% improvement. Remission status, based on the asymptomatic range and a lower PHQ-9 score, may provide a useful additional category of clinical change.

A recent meta-analysis by Benish, Imel, and Wampold (2008, Clinical Psychology Review, 28, 746-758) concluded that all bona fide treatments are equally effective in posttraumatic stress disorder (PTSD). In contrast, seven other meta-analyses or systematic reviews concluded that there is good evidence that trauma-focused psychological treatments (trauma-focused cognitive behavior therapy and eye movement desensitization and reprocessing) are effective in PTSD; but that treatments that do not focus on the patients' trauma memories or their meanings are either less effective or not yet sufficiently studied. International treatment guidelines therefore recommend trauma-focused psychological treatments as first-line treatments for PTSD. We examine possible reasons for the discrepant conclusions and argue that (1) the selection procedure of the available evidence used in Benish et al.'s (2008)meta-analysis introduces bias, and (2) the analysis and conclusions fail to take into account the need to demonstrate that treatments for PTSD are more effective than natural recovery. Furthermore, significant increases in effect sizes of trauma-focused cognitive behavior therapies over the past two decades contradict the conclusion that content of treatment does not matter. To advance understanding of the optimal treatment for PTSD, we recommend further research into the active mechanisms of therapeutic change, including treatment elements commonly considered to be non-specific. We also recommend transparency in reporting exclusions in meta-analyses and suggest that bona fide treatments should be defined on empirical and theoretical grounds rather than by judgments of the investigators' intent.

How are people's social policy attitudes related to their affective reactions to the social groups affected by those policies? from a threat-based perspective, specific emotions toward a group-above and beyond general prejudice toward that group-should predict attitudes toward a policy affecting the group. To test this, 128 participants reported their support for four social policies, their general and specific affective reactions to each affected group, and the threats ostensibly posed by that group. Although general prejudice failed to predict each policy attitude after controlling for the specific emotions, specific emotions did indeed significantly predict each policy attitude after controlling for general prejudice. Moreover, these specific emotions tended to mediate predicted relationships between perceived threats and policy attitudes. In all, these results highlight the benefits of assessing specific intergroup emotions as they relate to political arenas. © 2009 Elsevier Inc. All rights reserved.

BACKGROUND: in the UK, bibliotherapy schemes have become a widespread source of support for people with common mental health disorders such as depression. However, the current evidence suggests that bibliotherapy schemes that are offered without guidance are not effective. It may be possible to improve the effectiveness of self-help books by incorporating into them some of the "common factors" that operate in personal therapeutic encounters, for example therapist responsiveness. AIM: the aim was to test whether and to what extent authors have incorporated common factors into self-help books. METHOD: a model of how common factors might be incorporated into CBT-based self-help books was developed and a sample of three books were examined against the model criteria. RESULTS: the sampled self-help books were found to have common factors to a greater or lesser extent, but some types of common factors were more prevalent than others. Factors addressing the development and maintenance of the therapeutic alliance were less often apparent. CONCLUSIONS: Self-help books have the potential to provide a valuable service to people with depression, but further work is necessary to develop them. It is suggested that future generations of self-help books should pay explicit attention to the use of common factors, in particular developing and investigating how factors such as flexibility, responsiveness and alliance-rupture repair can be woven into the text.

Background: There is a considerable evidence base for 'collaborative care' as a method to improve quality of care for depression, but an acknowledged gap between efficacy and implementation. This study utilises the Normalisation Process Model (NPM) to inform the process of implementation of collaborative care in both a future full-scale trial, and the wider health economy.Methods: Application of the NPM to qualitative data collected in both focus groups and one-to-one interviews before and after an exploratory randomised controlled trial of a collaborative model of care for depression.Results: Findings are presented as they relate to the four factors of the NPM (interactional workability, relational integration, skill-set workability, and contextual integration) and a number of necessary tasks are identified. Using the model, it was possible to observe that predictions about necessary work to implement collaborative care that could be made from analysis of the pre-trial data relating to the four different factors of the NPM were indeed borne out in the post-trial data. However, additional insights were gained from the post-trial interview participants who, unlike those interviewed before the trial, had direct experience of a novel intervention. The professional freedom enjoyed by more senior mental health workers may work both for and against normalisation of collaborative care as those who wish to adopt new ways of working have the freedom to change their practice but are not obliged to do so.Conclusions: the NPM provides a useful structure for both guiding and analysing the process by which an intervention is optimized for testing in a larger scale trial or for subsequent full-scale implementation. © 2010 Gask et al; licensee BioMed Central Ltd.

BACKGROUND: Comprising of both organisational and patient level components, collaborative care is a potentially powerful intervention for improving depression treatment in UK primary Care. However, as previous models have been developed and evaluated in the United States, it is necessary to establish the effect of collaborative care in the UK in order to determine whether this innovative treatment model can replicate benefits for patients outside the US. This Phase III trial was preceded by a Phase II patient level RCT, following the MRC Complex Intervention Framework. METHODS/DESIGN: a multi-centre controlled trial with cluster-randomised allocation of GP practices. GP practices will be randomised to usual care control or to "collaborative care" - a combination of case manager coordinated support and brief psychological treatment, enhanced specialist and GP communication. The primary outcome will be symptoms of depression as assessed by the PHQ-9. DISCUSSION: If collaborative care is demonstrated to be effective we will have evidence to enable the NHS to substantially improve the organisation of depressed patients in primary care, and to assist primary care providers to deliver a model of enhanced depression care which is both effective and acceptable to patients.

Objectives: to provide an overview of methods to identify postnatal depression (PND) in primary care and to assess their validity, acceptability, clinical effectiveness and cost-effectiveness, to model estimates of cost, to assess whether any method meets UK National Screening Committee (NSC) criteria and to identify areas for future research. Data sources: Searches of 20 electronic databases (including MEDLINE, CINAHL, PsycINFO, EMBASE, CENTRAL, DARE and CDSR), forward citation searching, personal communication with authors and searching of reference lists. Review methods: a generalised linear mixed model approach to the bivariate meta-analysis was undertaken for the validation review with quality assessment using QUADAS. Within the acceptability review, a textual narrative approach was employed to synthesise qualitative and quantitative research evidence. For the clinical and cost-effectiveness reviews methods outlined by the Centre for Reviews and Dissemination and the Cochrane Collaboration were followed. Probabilistic models were developed to estimate the costs associated with different identification strategies. Results: the Edinburgh Postnatal Depression Scale (EPDS) was the most frequently explored instrument across all of the reviews. In terms of test performance, postnatally the EPDS performed reasonably well: sensitivity ranged from 0.60 (specificity 0.97) to 0.96 (specificity 0.45) for major depression only; from 0.31 (specificity 0.99) to 0.91 (specificity 0.67) for major or minor depression; and from 0.38 (specificity 0.99) to 0.86 (specificity 0.87) for any psychiatric disorder. Evidence from the acceptability review indicated that, in the majority of studies, the EPDS was acceptable to women and health-care professionals when women were forewarned of the process, when the EPDS was administered in the home, with due attention to training, with empathetic skills of the health visitor and due consideration to positive responses to question 10 about self-harm. Suggestive evidence from the clinical effectiveness review indicated that use of the EPDS, compared with usual care, may lead to reductions in the number of women with depression scores above a threshold. In the absence of existing cost-effectiveness studies of PND identification strategies, a decision-analytic model was developed. The results of the base-case analysis suggested that use of formal identification strategies did not appear to represent value for money, based on conventional thresholds of cost-effectiveness used in the NHS. However, the scenarios considered demonstrated that this conclusion was primarily driven by the costs of false positives assumed in the base-case model. Conclusions: in light of the results of our evidence synthesis and decision modelling we revisited the examination of PND screening against five of the NSC criteria. We found that the accepted criteria for a PND screening programme were not currently met. The evidence suggested that there is a simple, safe, precise and validated screening test, in principle a suitable cut-off level could be defined and that the test is acceptable to the population. Evidence surrounding clinical and cost-effectiveness of methods to identify PND is lacking. Further research should aim to identify the optimal identification strategy, in terms of key psychometric properties for postnatal populations. In particular, research comparing the performance of the Whooley and help questions, the EPDS and a generic depression measure would be informative. It would also be informative to identify the natural history of PND over time and to identify the clinical effectiveness of the most valid and acceptable method to identify PND. Further research within a randomised controlled trial would provide robust estimates of the clinical effectiveness. © 2009 Queen's Printer and Controller of HMSO. All rights reserved.

OBJECTIVES: to provide an overview of methods to identify postnatal depression (PND) in primary care and to assess their validity, acceptability, clinical effectiveness and cost-effectiveness, to model estimates of cost, to assess whether any method meets UK National Screening Committee (NSC) criteria and to identify areas for future research. DATA SOURCES: Searches of 20 electronic databases (including MEDLINE, CINAHL, PsycINFO, EMBASE, CENTRAL, DARE and CDSR), forward citation searching, personal communication with authors and searching of reference lists. REVIEW METHODS: a generalised linear mixed model approach to the bivariate meta-analysis was undertaken for the validation review with quality assessment using QUADAS. Within the acceptability review, a textual narrative approach was employed to synthesise qualitative and quantitative research evidence. For the clinical and cost-effectiveness reviews methods outlined by the Centre for Reviews and Dissemination and the Cochrane Collaboration were followed. Probabilistic models were developed to estimate the costs associated with different identification strategies. RESULTS: the Edinburgh Postnatal Depression Scale (EPDS) was the most frequently explored instrument across all of the reviews. In terms of test performance, postnatally the EPDS performed reasonably well: sensitivity ranged from 0.60 (specificity 0.97) to 0.96 (specificity 0.45) for major depression only; from 0.31 (specificity 0.99) to 0.91 (specificity 0.67) for major or minor depression; and from 0.38 (specificity 0.99) to 0.86 (specificity 0.87) for any psychiatric disorder. Evidence from the acceptability review indicated that, in the majority of studies, the EPDS was acceptable to women and health-care professionals when women were forewarned of the process, when the EPDS was administered in the home, with due attention to training, with empathetic skills of the health visitor and due consideration to positive responses to question 10 about self-harm. Suggestive evidence from the clinical effectiveness review indicated that use of the EPDS, compared with usual care, may lead to reductions in the number of women with depression scores above a threshold. In the absence of existing cost-effectiveness studies of PND identification strategies, a decision-analytic model was developed. The results of the base-case analysis suggested that use of formal identification strategies did not appear to represent value for money, based on conventional thresholds of cost-effectiveness used in the NHS. However, the scenarios considered demonstrated that this conclusion was primarily driven by the costs of false positives assumed in the base-case model. CONCLUSIONS: in light of the results of our evidence synthesis and decision modelling we revisited the examination of PND screening against five of the NSC criteria. We found that the accepted criteria for a PND screening programme were not currently met. The evidence suggested that there is a simple, safe, precise and validated screening test, in principle a suitable cut-off level could be defined and that the test is acceptable to the population. Evidence surrounding clinical and cost-effectiveness of methods to identify PND is lacking. Further research should aim to identify the optimal identification strategy, in terms of key psychometric properties for postnatal populations. In particular, research comparing the performance of the Whooley and help questions, the EPDS and a generic depression measure would be informative. It would also be informative to identify the natural history of PND over time and to identify the clinical effectiveness of the most valid and acceptable method to identify postnatal depression. Further research within a randomised controlled trial would provide robust estimates of the clinical effectiveness.

To provide an overview of methods to identify postnatal depression (PND) in primary care and to assess their validity, acceptability, clinical effectiveness and cost-effectiveness, to model estimates of cost, to assess whether any method meets UK National Screening Committee (NSC) criteria and to identify areas for future research. Searches of 20 electronic databases (including MEDLINE, CINAHL, PsycINFO, EMBASE, CENTRAL, DARE and CDSR), forward citation searching, personal communication with authors and searching of reference lists. A generalised linear mixed model approach to the bivariate meta-analysis was undertaken for the validation review with quality assessment using QUADAS. Within the acceptability review, a textual narrative approach was employed to synthesise qualitative and quantitative research evidence. For the clinical and cost-effectiveness reviews methods outlined by the Centre for Reviews and Dissemination and the Cochrane Collaboration were followed. Probabilistic models were developed to estimate the costs associated with different identification strategies. The Edinburgh Postnatal Depression Scale (EPDS) was the most frequently explored instrument across all of the reviews. In terms of test performance, postnatally the EPDS performed reasonably well: sensitivity ranged from 0.60 (specificity 0.97) to 0.96 (specificity 0.45) for major depression only; from 0.31 (specificity 0.99) to 0.91 (specificity 0.67) for major or minor depression; and from 0.38 (specificity 0.99) to 0.86 (specificity 0.87) for any psychiatric disorder. Evidence from the acceptability review indicated that, in the majority of studies, the EPDS was acceptable to women and health-care professionals when women were forewarned of the process, when the EPDS was administered in the home, with due attention to training, with empathetic skills of the health visitor and due consideration to positive responses to question 10 about self-harm. Suggestive evidence from the clinical effectiveness review indicated that use of the EPDS, compared with usual care, may lead to reductions in the number of women with depression scores above a threshold. In the absence of existing cost-effectiveness studies of PND identification strategies, a decision-analytic model was developed. The results of the base-case analysis suggested that use of formal identification strategies did not appear to represent value for money, based on conventional thresholds of cost-effectiveness used in the NHS. However, the scenarios considered demonstrated that this conclusion was primarily driven by the costs of false positives assumed in the base-case model. In light of the results of our evidence synthesis and decision modelling we revisited the examination of PND screening against five of the NSC criteria. We found that the accepted criteria for a PND screening programme were not currently met. The evidence suggested that there is a simple, safe, precise and validated screening test, in principle a suitable cut-off level could be defined and that the test is acceptable to the population. Evidence surrounding clinical and cost-effectiveness of methods to identify PND is lacking. Further research should aim to identify the optimal identification strategy, in terms of key psychometric properties for postnatal populations. In particular, research comparing the performance of the Whooley and help questions, the EPDS and a generic depression measure would be informative. It would also be informative to identify the natural history of PND over time and to identify the clinical effectiveness of the most valid and acceptable method to identify postnatal depression. Further research within a randomised controlled trial would provide robust estimates of the clinical effectiveness.

The randomised controlled trial (RCT) is at the heart of the evidence-based medicine movement and by implication should also be central to evidence-based nursing. One objection to RCTs in nursing science is that nursing is too complex an activity to be subjected to a carefully controlled experimental paradigm. We suggest that this argument is false and use examples from complex interventions research in nursing and experimental laboratory methods to demonstrate that RCTs can bring much needed clarity to the search for nursing knowledge. © 2008 Elsevier Ltd. All rights reserved.

BACKGROUND: Collaborative care is an effective intervention for depression which includes both organizational and patient-level intervention components. The effect in the UK is unknown, as is whether cluster- or patient-randomization would be the most appropriate design for a Phase III clinical trial. METHOD: We undertook a Phase II patient-level randomized controlled trial in primary care, nested within a cluster-randomized trial. Depressed participants were randomized to 'collaborative care' - case manager-coordinated medication support and brief psychological treatment, enhanced specialist and GP communication - or a usual care control. The primary outcome was symptoms of depression (PHQ-9). RESULTS: We recruited 114 participants, 41 to the intervention group, 38 to the patient randomized control group and 35 to the cluster-randomized control group. For the intervention compared to the cluster control the PHQ-9 effect size was 0.63 (95% CI 0.18-1.07). There was evidence of substantial contamination between intervention and patient-randomized control participants with less difference between the intervention group and patient-randomized control group (-2.99, 95% CI -7.56 to 1.58, p=0.186) than between the intervention and cluster-randomized control group (-4.64, 95% CI -7.93 to -1.35, p=0.008). The intra-class correlation coefficient for our primary outcome was 0.06 (95% CI 0.00-0.32). CONCLUSIONS: Collaborative care is a potentially powerful organizational intervention for improving depression treatment in UK primary care, the effect of which is probably partly mediated through the organizational aspects of the intervention. A large Phase III cluster-randomized trial is required to provide the most methodologically accurate test of these initial encouraging findings.

BACKGROUND: Current guidelines for the management of depression suggest the use of guided self-help for patients with mild to moderate disorders. However, there is little consensus concerning the optimal form and delivery of this intervention. To develop acceptable and effective interventions, a phased process has been proposed, using a modelling phase to examine and develop an intervention prior to preliminary testing in an exploratory trial. This paper (a) describes the modelling phase used to develop a guided self-help intervention for depression in primary care and (b) reports data from an exploratory randomised trial of the intervention. METHODS: a guided self-help intervention was developed following a modelling phase which involved a systematic review, meta synthesis and a consensus process. The intervention was then tested in an exploratory randomised controlled trial by examining (a) fidelity using analysis of taped guided self-help sessions (b) acceptability to patients and professionals through qualitative interviews (c) effectiveness through estimation of the intervention effect size. RESULTS: Fifty eight patients were recruited to the exploratory trial. Seven professionals and nine patients were interviewed, and 22 tapes of sessions analysed for fidelity. Generally, fidelity to the intervention protocol was high, and the professionals delivered the majority of the specific components (with the exception of the use of feedback). Acceptability to both professionals and patients was also high. The effect size of the intervention on outcomes was small, and in line with previous analyses showing the modest effect of guided self-help in primary care. However, the sample size was small and confidence intervals around the effectiveness estimate were wide. CONCLUSION: the general principles of the modelling phase adopted in this study are designed to draw on a range of evidence, potentially providing an intervention that is evidence-based, patient-centred and acceptable to professionals. However, the pilot outcome data did not suggest that the intervention developed was particularly effective. The advantages and disadvantages of the general methods used in the modelling phase are discussed, and possible reasons for the failure to demonstrate a larger effect in this particular case are outlined.

Access to psychological therapies for people presenting with common mental health problems within the United Kingdom has tended to be poor and limited by the quality of local services. This is especially the case for people presenting to their general practitioner within primary care who historically have been faced with the unacceptable choice of either only medication or referral to psychological interventions but with the proviso of long waiting times, frequently in excess of 12 months. Recent progress around the development of evidence based clinical guidelines within the UK, has meant that psychological therapies have been recommended as both highly effective, relatively safe and economically viable for a wide range of common mental health problems, particularly anxiety and depression. At the same time the significant costs to individuals and Society in terms of the adverse consequences of poor mental health on well-being, capacity to work and the economic impacts on both the health system generally and more specifically the exchequer, in the form of incapacity benefits and payments, has become more widely appreciated. This paper describes the rationale behind and the implementation of a national programme of government investment, Improving Access to Psychological Therapies, within England, to provide a choice of well-resourced, evidence based psychological therapies to those individuals in primary care who experience common mental health problems, and to support generally their recovery and functioning within employment and Society.

BACKGROUND: Web-based technologies are increasingly being used to create modes of online learning for nurses but their effect has not been assessed in nurse education. OBJECTIVES: Assess whether participation in face-to-face discussion seminars or online asynchronous discussion groups had different effects on educational attainment in a web-based course. DESIGN: Non-randomised or quasi-experimental design with two groups-students choosing to have face-to-face discussion seminars and students choosing to have online discussions. SETTING: the Core Methods module of a postgraduate research methods course. PARTICIPANTS: all 114 students participating in the first 2 yr during which the course teaching material was delivered online. OUTCOME: Assignment mark for Core Methods course module. METHODS: Background details of the students, their choices of modules and assignment marks were collected as part of the routine course administration. Students' online activities were identified using the student tracking facility within WebCT. Regression models were fitted to explore the association between available explanatory variables and assignment mark. RESULTS: Students choosing online discussions had a higher Core Methods assignment mark (mean 60.8/100) than students choosing face-to-face discussions (54.4); the difference was statistically significant (t=3.13, df=102, p=0.002), although this ignores confounding variables. Among online discussion students, assignment mark was significantly correlated with the numbers of discussion messages read (Kendall's tau(b)=0.22, p=0.050) and posted (Kendall's tau(b)=0.27, p=0.017); among face-to-face discussion students, it was significantly associated with the number of non-discussion hits in WebCT (Kendall's tau(b)=0.19, p=0.036). In regression analysis, choice of discussion method, whether an M.Phil./Ph.D. student, number of non-discussion hits in WebCT, number of online discussion messages read and number posted were associated with assignment mark at the 5% level of significance when taken singly; in combination, only whether an M.Phil./Ph.D. student (p=0.024) and number of non-discussion hits (p=0.045) retained significance. CONCLUSIONS: This study demonstrates that a research methods course can be delivered to postgraduate healthcare students at least as successfully by an entirely online method in which students participate in online discussion as by a blended method in which students accessing web-based teaching material attend face-to-face seminar discussions. Increased online activity was associated with higher assignment marks. The study highlights new opportunities for educational research that arise from the use of virtual learning environments that routinely record the activities of learners and tutors.

Objective: to determine which variables predict stress (psychological distress) in pre-registration midwifery students. Design: a cross-sectional survey, using a range of self-report measures bound together in a 'questionnaire pack'. Setting: the study reported here is taken from a wider investigation into stress among nursing and midwifery students, undertaken in the nursing and midwifery department of a large university in Northern England. Participants: 120 pre-registration midwifery students pursuing one of three diploma programmes: 'standard', 'enhanced' and 'short'. Measurements: multivariate logistic regression was used as the analytical technique. The variables used in the analyses undertaken were all derived from formal and study-specific, self-report measures included in the questionnaire pack. 'Stress' (whether a participant was psychologically distressed or not) was obtained via the General Health Questionnaire. Potential predictors of stress were collected from two formal measures (the Student Nurse Stress Index and the Coping Inventory for Stressful Situations) and from questions in the questionnaire pack designed to elicit demographic data and data of specific interest to nurse and midwife educators. Findings: 102 questionnaire packs (85%) were returned. The prevalence of stress among participants was over 40%. A series of logistic regression analyses resulted in five competing regression models. Through a systematic selection process, two of these models were chosen for discussion. These models suggested that the key predictors of psychological distress in the population studied were self-report of stress levels, the type of midwifery programme being pursued, the use of 'task-oriented' coping and, possibly, whether or not a student smokes cigarettes. Key conclusions and implications for practice: despite the prevalence rate of 40%, the prevalence of stress among midwifery students is generally no better or worse than that of other students or of qualified health-care professionals. Those involved in midwifery education need to know how to manage student stress effectively. This can be achieved by ensuring that personal teachers (continue to) play a key role in supporting students, especially when students self-report high levels of stress. Incorporating formal stress-management training into pre-registration midwifery programmes may also be useful. Sound knowledge of the issues associated with student stress during curriculum design, however, may ultimately prove to be the most effective way of managing student stress. In a discipline such as midwifery, these issues are as divergent as the politics of midwifery, the processes used in recruitment and selection, the role of women in society, and the nature, quality and quantity of the learning experiences and the assessment strategies used. © 2006 Elsevier Ltd. All rights reserved.

BACKGROUND: the relative efficacy of different psychological treatments for chronic post-traumatic stress disorder (PTSD) is unclear. AIMS: to determine the efficacy of specific psychological treatments for chronic PTSD. METHOD: in a systematic review of randomised controlled trials, eligible studies were assessed against methodological quality criteria and data were extracted and analysed. RESULTS: Thirty-eight randomised controlled trials were included in the meta-analysis. Trauma-focused cognitive-behavioural therapy (TFCBT), eye movement desensitisation and reprocessing (EMDR), stress management and group cognitive-behavioural therapy improved PTSD symptoms more than waiting-list or usual care. There was inconclusive evidence regarding other therapies. There was no evidence of a difference in efficacy between TFCBT and EMDR but there was some evidence that TFCBT and EMDR were superior to stress management and other therapies, and that stress management was superior to other therapies. CONCLUSIONS: the first-line psychological treatment for PTSD should be trauma-focused (TFCBT or EMDR).

When people observe competitions, they are often drawn to figures that are seen as disadvantaged or unlikely to prevail. The present research tested the scope and limits of people's support for underdogs. The first two studies demonstrated, in the context of Olympic matches (Study 1) and the Israeli-Palestinian conflict (Study 2), that observers' support for a competitor increased when framing it as an underdog. The final two studies explored mechanisms underlying support for underdogs. Study 3 showed that participants attributed more effort to a team when they believed it to be an underdog, and perceptions of effort mediated liking. In Study 4, participants reading a hypothetical sporting event supported a team with a low probability of success and labeled it an underdog unless it had greater resources than an opponent, suggesting that low expectations by themselves do not engender support if positive outcomes are not seen as deserved. © 2007 by the Society for Personality and Social Psychology, Inc.

Background: Those working in psychiatric units care for some of the most vulnerable and needy patients within health services, and suffer some of the highest levels of job dissatisfaction and burnout within healthcare workforce. Poor staff morale is bad for patient care and is economically wasteful. The same level of evidence of effectiveness and efficiency should be considered in workforce planning as is required in patient care. This has hitherto not occurred. Aim: to examine the impact and cost effectiveness of strategies to improve staff morale and reduce "burnout" amongst staff working in psychiatric units. Methods: We conducted a systematic review of robust evaluations of strategies designed to improve psychological wellbeing or the working experience of staff working in psychiatric units. We searched the following databases: EMBASE; MEDLINE; PsycINFO; CINAHL; Sociological Abstracts; HMIC; Management and Marketing Abstracts; Management Contents and Inside Conferences (all to 2004), and sought the following outcomes: Psychological wellbeing; Job satisfaction; staff burnout and stress; staff sickness and turnover; Direct and indirect costs. The following designs were included: Randomised Controlled Trails (RCTs); Controlled Clinical Trials (CCTs); Controlled Before and after studies (CBAs); and interrupted time series (ITSs). We conducted a narrative overview of key design features, endpoints and results. Results: We identified eight evaluations of strategies to improve staff morale (3 RCTs; 3 CCTs and 2 CBAs). Educational interventions designed to enhance the skill and competency of staff were the most commonly evaluated, and showed positive impact on at least one outcome of interest. Psycho-social interventions that sought out members of staff who were experiencing emotional problems and offered work-based support and enhanced social support networks were positive in US healthcare settings, but had been incompletely implemented and evaluated in UK settings. Organisational interventions, such as a shift to continuous care and primary nursing also showed a potential to be effective in reducing sickness rates and improving job satisfaction. Conclusions: There is substantial opportunity to design and implement interventions to improve the working experience of staff in psychiatric units. There is an onus to evaluate the longer term impact and cost effectiveness of these strategies. Unfortunately strategies are currently being implemented in the absence of any prospective evaluation. Declaration of interest: the authors have no conflict of interest. © Shadowfax Publishing and Taylor & Francis.

BACKGROUND: Depression is common in primary care but is suboptimally managed. Collaborative care, that is, structured care involving a greater role of nonmedical specialists to augment primary care, has emerged as a potentially effective candidate intervention to improve quality of primary care and patient outcomes. METHODS: to quantify the short-term and longer-term effectiveness of collaborative care compared with standard care and to understand mechanisms of action by exploring between-study heterogeneity, we conducted a systematic review of randomized controlled trials that compared collaborative care with usual primary care in patients with depression. We searched MEDLINE (from the beginning of 1966), EMBASE (from the beginning of 1980), CINAHL (from the beginning of 1980), PsycINFO (from the beginning of 1980), the Cochrane Library (from the beginning of 1966), and DARE (Database of Abstracts of Reviews of Effectiveness) (from the beginning of 1985) databases from study inception to February 6, 2006. RESULTS: We found 37 randomized studies including 12 355 patients with depression receiving primary care. Random effects meta-analysis showed that depression outcomes were improved at 6 months (standardized mean difference, 0.25; 95% confidence interval, 0.18-0.32), and evidence of longer-term benefit was found for up to 5 years (standardized mean difference, 0.15; 95% confidence interval, 0.001-0.31). When exploring determinants of effectiveness, effect size was directly related to medication compliance and to the professional background and method of supervision of case managers. The addition of brief psychotherapy did not substantially improve outcome, nor did increased numbers of sessions. Cumulative meta-analysis showed that sufficient evidence had emerged by 2000 to demonstrate the statistically significant benefit of collaborative care. CONCLUSIONS: Collaborative care is more effective than standard care in improving depression outcomes in the short and longer terms. Future research needs to address the implementation of collaborative care, particularly in settings other than the United States.

In the UK, recent guidelines on the treatment of depression and anxiety recommend CBT-based self-help materials as one important component of services. However, despite being based on specific CBT techniques or "empirically grounded interventions", early optimism has been dented by data from recent studies that have cast doubt on the effectiveness of the current generation of these materials. As a consequence, it may be necessary to consider that other factors may contribute to the overall magnitude of CBT effects. Indeed, it is logically inconsistent to argue that specific factors are pre-eminent in CBT whilst maintaining that delivery via therapists is more likely to be effective than self-help. The contribution of "common factors" that operate in personal therapeutic encounters, for example, therapist responsiveness and the patient-therapist alliance, may be one possible overlooked reason for the reduced effectiveness of self-help materials. The development of the next generation of self-help materials, therefore, may benefit from the testing of materials that combine common and specific factors, including specific measurement of the strength of common factors and their relationship to clinical outcomes. We discuss a model of such common factors and suggest how they could be incorporated into the next generation of CBT based self-help materials. © 2006 British Association for Behavioural and Cognitive Psychotherapies.

AIM: This paper reports the development, piloting and validation of a tool to measure attitudes for use with nursing staff working in acute mental health care units. BACKGROUND: the quality of care provided for service users in acute mental health care has come under both scrutiny and severe criticism. The attitudes of staff working in these environments have been cited as a contributory factor in poor care. No measure of attitudes specific to acute mental health has been reported. METHODS: a 64-question measure was constructed and distributed to a sample of qualified and unqualified nurses drawn from seven mental health care units in the North of England. Exploratory factor analysis and a number of other statistical tests were performed to validate the questionnaire. RESULTS: Preliminary analysis reduced the original 64 questions to 37. Five components were retained, accounting for 42% of the variance, and the five rotated factors were identified. The resultant 'Attitudes Towards Acute Mental Health Scale' (ATAMHS) achieved good internal reliability, with a Cronbach's alpha of 0.72. CONCLUSION: the construction and validation of the ATAMHS measure will enable improved understanding of the attitudes of nursing staff working in acute mental health care settings to occur. This measure is available for use in a clinical area of nursing in which attitude change is of fundamental importance for future development of care.

Background: Most people in contemporary western society die of the chronic diseases of old age. Whilst palliative care is appropriate for elderly patients with chronic, non-malignant disease, few of these patients access such care compared with cancer patients. Objective referral criteria based on accurate estimation of survival may facilitate more timely referral of non-cancer patients most appropriate for specialist palliative care. Objective: to identify tools and predictor variables that might aid clinicians estimate survival and assess palliative status in non-cancer patients aged 65 years and older. Methods: Systematic review and quality assessment using criteria modified from the literature. Results: 11 studies that evaluated prognoses in hospitalised and community-based older adults with non-malignant disease were identified. Key generic predictors of survival were increased dependency of activities of daily living, presence of comorbidities, poor nutritional status and weight loss, and abnormal vital signs and laboratory values. Disease-specific predictors of survival were identified for dementia, chronic obstructive pulmonary disorder and congestive heart failure. No study evaluated the relationship between survival and palliative status. Conclusion: Prognostic models that attempt to estimate survival of ≤6 months in non-cancer patients have generally poor discrimination, reflecting the unpredictable nature of most non-malignant disease. However, a number of generic and disease-specific predictor variables were identified that may help clinicians identify older, non-cancer patients with poor prognoses and palliative care needs. Simple, well-validated prognostic models that provide clinicians with objective measures of palliative status in non-cancer patients are needed. Additionally, research that evaluates the effect of general and specialist palliative care on psychosocial outcomes in non-cancer patients and their carers is needed. © the Author 2005. Published by Oxford University Press on behalf of the British Geriatrics Society.

AIM: This paper reports a study to evaluate the impact of an innovative 18-day educational intervention for acute ward-based mental healthcare nursing staff on documented quality of nursing care and on service user views of that care. BACKGROUND: There are grave concerns internationally about the quality of inpatient mental health care for people with acute psychiatric problems. It is claimed that specialist educational courses are needed to improve these services. However, whilst such courses may lead to positive learning outcomes for participants, the impact on the actual care of service users is unknown. METHOD: an uncontrolled before-and-after evaluation of three acute mental health wards from different United Kingdom National Health Service trusts was carried out. Quality of nursing care was evaluated by extracting documentary evidence from service user records, assessed by two independent researchers according to predefined quality criteria. The views of a purposive sample of mental health service users, currently receiving services from the three designated wards, were ascertained by semi-structured interview. RESULTS: Both documentary evidence and service user views revealed some important baseline deficiencies in the quality of care offered at the study sites. Following the educational intervention, statistically significant improvements were observed in the quality of care planning, initial assessments and the provision of therapeutic care. No statistically significant changes were observed in the quality of risk assessments, medication management or external agency involvement. CONCLUSIONS: Education can have an impact on nursing care but may not be sufficient alone to change mental healthcare practices on acute inpatient wards in the radical manner demanded by policymakers and service user lobby groups. Educational interventions need to be implemented in conjunction with organizational changes that are specifically designed to maximize the opportunities presented by a newly skilled and positive workforce.

AIM: This paper reports a study to ascertain the views of acute ward-based mental health nursing staff on the delivery, content and personal impact of an innovative 18-day, whole team educational intervention in acute mental health care. BACKGROUND: There are grave concerns internationally about the quality of inpatient mental health care for people with acute psychiatric problems. Educational courses are needed to improve these services. However, existing schemes are often selective, hard to access and limited to developing highly specialist skills for senior nurses. They have also been criticized for making no difference to clinical practice. There is little evidence to guide the development of these or alternative team-based courses. METHOD: Qualitative data were collected over a 6-week period using 12 focus group interviews and individual questionnaires. RESULTS: Four themes were identified. The joint education of nursing staff from different organizations was welcomed and reduced feelings of ward isolation. Mixing qualified and unqualified staff was not regarded positively. In terms of course content and learning themes, unqualified staff were more likely to report positive learning outcomes for knowledge, skills, attitude, morale and personal development; qualified nurses were more likely to indicate positive outcomes in anonymized data from questionnaires than from focus groups. Both groups reported little chance of knowledge implementation without changes in the organization of care. CONCLUSION: Whilst it may be desirable to educate whole nursing teams, more benefit might be gained from shared education between several organizations and separating the education of qualified and unqualified staff before combining these groups in team education. Participants remained pessimistic about their chances of implementing new knowledge and skills in current acute inpatient mental health environments.

BACKGROUND: There are significant barriers to accessing effective psychological therapy in primary care resulting from a lack of suitably trained therapists to meet current demand. More efficient service delivery using minimal interventions (such as bibliotherapy) provided by paraprofessional therapists may be one method of overcoming these problems, and is the subject of attention in the UK and elsewhere. A randomized trial was conducted to test the clinical effectiveness of this model. Assistant psychologists delivered a guided self-help intervention to patients with anxiety and depression who were currently waiting for psychological therapy. METHOD: a total of 114 patients were randomized either to guided self-help or a waiting-list control group. All patients were followed up 3 months later, prior to starting conventional psychological therapy. Measures included self-reported adherence to the intervention, anxiety and depressive symptoms, social functioning and patient satisfaction. RESULTS: Adherence to the guided self-help intervention was acceptable and patients reported satisfaction with the intervention. However, there were no statistically significant differences between groups in anxiety and depression symptoms at 3 months. CONCLUSIONS: the results demonstrate that this model of guided self-help did not provide additional benefit to patients on a waiting list for psychological therapy. The results are considered in the context of possible internal and external validity threats, and compared with previous trials of minimal interventions. The implications of the results for the design of future minimal interventions are considered.

Modern versions of Computer Assisted Qualitative Data Analysis Software ( CAQDAS) are enabling the analysis of audio sound files instead of relying solely on text-based analysis. Along with other developments in computer technologies such as the proliferation of digital recording devices and the potential for using streamed media in online academic publication, this innovation is increasing the possibilities of systematically using media-rich, naturalistic data in place of transcribed 'de-naturalised' forms. This paper reports on a project assessing online learning materials that used Atlas. ti software to analyse sound files, and it describes the problems faced in gathering, analysing and using this data for report writing. It concludes that there are still serious barriers to the full and effective integration of audio data into qualitative research: the absence of 'industry standard' recording technology, the underdevelopment of audio interfaces in Atlas. ti ( as a key CAQDAS package), and the conventional approach to data use in many online publication formats all place serious restrictions on the integrated use of this data. Nonetheless, it is argued here that there are clear benefits in pushing for resolutions to these problems as the use of this naturalistic data through digital formats may help qualitative researchers to overcome some long-standing methodological issues: in particular, the ability to overcome the reliance on data transcription rather than 'natural' data, and the possibility of implementing research reports that facilitate a more transparent use of 'reusable' data, are both real possibilities when using these digital technologies, which could substantially change the shape of qualitative research practice.

This paper reports an audit of Mental Health Trusts in North West England. The aim of the study was to investigate recruitment of community psychiatric nurses (CPNs), and to explore the experiences of the professionals trying to recruit nursing staff. A telephone survey was carried out in Autumn 2003 of five Mental Health (MH) Trusts in North West England. Telephone interviews with Human Resources staff and senior managers were set up although some conversations took place by E-mail. Content analysis of the notes of the telephone and e-mail conversations was carried out. It was hard to establish a true picture of nurse vacancies initially because it was difficult to find the appropriate person to speak to. It became apparent that recruitment and vacancies were recorded in terms of a person or post rather than hours. Managers admitted than posts were often filled with part-time staff. Using nursing hours as a measure of staffing levels rather than counting individuals gives a more accurate picture of staffing levels but such data was not available. In addition, it was reported that a post unfilled for more than three months stops being counted as a vacancy. It was reported that the amount being spent on temporary or "bank" nurses has increased sharply in the past five years, which strongly suggests that there are not currently enough permanent nurses in post. In addition, an increase in international recruitment was reported and managers reported that recruitment to CPN posts was often at the expense of inpatient units. This study confirms the perception amongst Mental Health Trust Managers of a shortage of Psychiatric Nurses. The paper describes the difficulties in obtaining accurate vacancy data, and the perceived difficulties in recruitment of nursing staff. We suggest that current arrangements of care for people with mental health problems delivered by CPNs may not be sustainable. © 2004 LIBRAPHARM LIMITED.

Objective: to assess the relative effects on consultation workload and costs of off-site triage by NHS Direct for patients requesting same day appointments compared with usual on-site nurse telephone triage in general practice. Design: Cluster randomised controlled trial. Setting Three primary care sites in York, England. Participants 4703 patients: 2452 with practice based triage, 2251 with NHS Direct triage. All consecutive patients making requests for same day appointments during study weeks were eligible for the trial. Main outcome measures Type of consultation after request for same day appointment (telephone, appointment, or visit); time taken for consultation; service use during the month after same day contact; costs of same day, follow up, and emergency care. Results: Patients in the NHS Direct group were less likely to have their call resolved by a nurse and were more likely to have an appointment with a general practitioner. Mean total time per patient in the NHS Direct group was 7.62 minutes longer than in the practice based group. Costs were greater in the NHS Direct group-£2.88 (95% confidence interval £0.88 to £4.87) per patient triaged-as a result of the difference between the groups in proportions of patients at each final point of contact after triage. Conclusions: External management of requests for same day appointments by nurse telephone triage through NHS Direct is possible but comes at a higher cost than practice nurse delivered triage in primary care. If NHS Direct could achieve the same proportions of consultation types as practice based triage, costs would be comparable.

Self-help programmes are increasingly advocated as a means of managing mental health problems. This qualitative study explored patients' understandings of the use of a UK primary care-based self-help clinic (facilitated by a nurse). As part of a wider evaluation of the clinic, in-depth interviews were conducted with a purposive sub-sample of clinic users. Data indicate that people understand their problem as one of having lost an ability to cope, and that the ethos underlying the clinic is well matched to restore a sense of coping, by motivating patients to re-establish and retain control over their everyday lives. However, some patients experienced a sense of dissonance between prior expectations and actual use of the self-help clinic. Without prior familiarity with self-help, engaging the patient as the mechanism of change may be difficult. Some patients expected formal counselling and were influenced in this by their previous experience of services and discussions with the GP at the point of referral. It takes time and active engagement with self-help materials before patients become aware that they are a crucial mechanism of change. Patients may benefit from information and a referral process, which emphasises the centrality of self-efficacy and the patient as 'change agent' prior to referral.

Background. Nurse telephone triage is a popular way of managing workload in primary care and has been shown to be as safe as general practitioner (GP)-delivered alternatives. No studies have tested a routine method of assessing the quality of decision-making by triage nurses in primary care. Aims. The aim of this paper is to describe a study to evaluate accuracy and utility of audiotaping telephone consultations to assess the quality of decisions made by practice nurses triaging same day appointment requests in routine practice. Method. An observational study was carried out using external assessment by GPs and nurse practitioners of triage quality in 218 audiotaped nurse telephone triage consultations. Results. There were high levels of agreement between triage nurses and assessors on identifying the presenting problem. However, there were only moderate levels of agreement between GPs and nurse assessors both on level of information sought (kappa = 0.434) and appropriateness of outcome (kappa = 0.614). Assessors rated information-gathering as poor in 19.3% of calls (95% confidence interval 14.6 to 25.0), and seven (3.2%) consultations were rated as potentially dangerous (95% confidence interval 1.6 to 6.5). A 1% sample of all consultations would have a probability of 0.48 of identifying unsafe consultations and 0.99 probability of identifying consultations with poor information-gathering. Conclusions. External assessment of triage quality may be of only moderate accuracy and reliability. Nonetheless, considerable information can be gleaned from assessing audiotapes to assess consultation quality. Even where nurses are generally highly skilled and competent, a 1% review of triage consultations would be sufficient to identify their information-gathering learning needs in relation to patients' presenting problems. Audio-taped consultations could be an important part of clinical governance strategies.

The ability of psychological treatment services to deliver effective and accessible mental healthcare, as demanded by the National Service Framework for mental health, is compromised by the traditional configuration of psychological therapy services, powerful gatekeeping by these services and the difficulties which exist in engaging primary care in mental healthcare. Although a number of service models have been suggested, most address access from the perspective of secondary care service providers. In particular, self-help, a powerful ideology and a clinically effective health technology, is given insufficient prominence in psychological therapy services. Self-help is often only considered for mild problems or as an adjunct to therapy, and it is assumed that mental health professionals with traditional therapeutic skills are needed to support self-help. Following a review of access and self-help in psychological therapies, the present authors propose criteria against which services could be designed in order to fully utilise self-help as a powerful health technology in psychological therapies. Accompanying these criteria is a research framework drawn from recent work on access and illness self-management that can be used to evaluate the performance of services attempting to improve access to psychological therapies.

BACKGROUND: Agoraphobia is a common and disabling mental health disorder. Substantial evidence supports the use of cognitive behaviour therapy (CBT), in particular the intervention termed exposure therapy, as the treatment of choice. However, although the evidence base for cognitive-behaviour therapy is extensive, the service delivery evidence base is poor, and alternative ways of delivering therapy are required if mental health services are to achieve standards set out by the National Service Framework in the United Kingdom. AIM: the study had two aims: (1) to develop a self-help manual, which could be facilitated by a nurse trained in CBT, for clients suffering from agoraphobia and (2) to pilot the self-help manual and evaluate its effectiveness. METHOD: the self-help manual was piloted with experienced nurses trained in CBT on three clinical sites for 10 weekly sessions of 30 minutes duration. A range of clinical outcome measures was administered by an independent assessor before and after treatment and at 1-month follow-up. RESULTS: a total of 18 clients completed treatment and results showed improvement on all clinical measures; improvement was maintained at 1-month follow-up. Importantly, 89% of clients were clinically significantly improved at post-treatment assessment. Clients were satisfied with their treatment and the self-help manual, and therapists found facilitated self-help an acceptable way to deliver treatment. CONCLUSION: Nurses can deliver effective support to patients using a self-help manual for agoraphobia. Although the results are promising, further work is required with larger numbers, longer follow-up and economic evaluation under controlled conditions. The work could also be adapted to different psychological conditions. Variation in the amount of specialist educational training is necessary to determine how many nurses are needed to support patients using self-help.

BACKGROUND: Nurses usually provide care for people with personality disorders on a day-to-day basis. Consequently, it is important to establish how effective nursing interventions are for those with personality disorders, both in terms of general management and more specific therapeutic approaches. These are also issues of current political and professional debate. The crucial question, however, for planners, providers and commissioners of services is, What research evidence is there about effectiveness? There is also a need to determine what further research is necessary to evaluate programmes for managing or modifying behaviours. AIM: the aim of this paper is to report on a systematic review of the literature on the effectiveness of nursing interventions in people with personality disorders, whether delivered by nurses alone or in combination with other health care professionals. METHOD: the review was conducted according to the United Kingdom National Health Service Centre for Reviews and Dissemination guidelines. Literature was identified from electronic database searching, footnote chasing, hand searching of journals and contact with authors of studies. Narrative synthesis was undertaken in relation to study design, participants, and type of intervention. FINDINGS: Eighteen separate studies were included in the review: four randomized controlled trials, four non-randomized controlled trials, seven before-and-after studies and three case studies. CONCLUSIONS: There is a weak evidence-base for what constitutes effective nursing intervention with people with personality disorders. There is stronger evidence from mixed disciplines intervention studies than from nursing only intervention studies. Studies of interventions based on psychological approaches show greater improvements in outcomes than nursing management studies.

Psychological therapy is widespread in primary care, but demand often exceeds supply. Innovative self-help approaches may overcome some problems associated with access to therapists. The feasibility, acceptability, efficiency, and effectiveness of a fast-access mental health self-help clinic were examined in a pilot study. The therapist saw 159 patients in 16 months, and on average required only one hour per patient. Generally, patients who used the clinic were satisfied. They reported similar levels of distress at baseline as patients in traditional psychological therapy services, and comparable outcomes. The self-help clinic approach should be evaluated formally within a randomised controlled trial.

Background: Common mental health problems account for up to 40% of all general practitioner (GP) consultations. Patients have limited access to evidence-based psychological therapies. Cognitive behavioural therapy self-help strategies offer one potential solution. Aim: to determine differences in clinical outcome, patient satisfaction and costs, between a cognitive behavioural-based self-help package facilitated by practice nurses compared to ordinary care by GPs for mild to moderate anxiety and depression. Design of study: Randomised controlled trial. Setting: Seventeen primary healthcare teams. Method: Patients presenting to their GP with mild to moderate anxiety and/or depression were recruited to the study and randomised to receive either a self-help intervention facilitated by practice nurses or ordinary care. The self-help intervention consisted of up to three appointments: two 1 week apart and a third 3 months later. There were no restrictions on ordinary care. Results: Intention-to-treat analysis showed that patients treated with practice nurse-supported cognitive behavioural therapy self-help attained similar clinical outcomes for similar costs and were more satisfied than patients treated by GPs with ordinary care. On-treatment analysis showed patients receiving the facilitated cognitive behavioural therapy self-help were more likely to be below clinical threshold at 1 month compared to the ordinary care group (odds ratio [OR] = 3.65, 95% confidence interval [CI] = 1.87 to 4.37). This difference was less well marked at 3 months (OR = 1.36, 95% CI= 0.52 to 3.56). Conclusion: Facilitated cognitive behavioural self-help may provide a short-term cost-effective clinical benefit for patients with mild to moderate anxiety and depression. This has the potential to help primary care provide a choice of effective psychological as well as pharmacological treatments for mental health problems.

BACKGROUND: Common mental health problems account for up to 40% of all general practitioner (GP) consultations. Patients have limited access to evidence-based psychological therapies. Cognitive behavioural therapy self-help strategies offer one potential solution. AIM: to determine differences in clinical outcome, patient satisfaction and costs, between a cognitive behavioural-based self-help package facilitated by practice nurses compared to ordinary care by GPs for mild to moderate anxiety and depression. DESIGN OF STUDY: Randomised controlled trial. SETTING: Seventeen primary healthcare teams. METHOD: Patients presenting to their GP with mild to moderate anxiety and/or depression were recruited to the study and randomised to receive either a self-help intervention facilitated by practice nurses or ordinary care. The self-help intervention consisted of up to three appointments: two 1 week apart and a third 3 months later. There were no restrictions on ordinary care. RESULTS: Intention-to-treat analysis showed that patients treated with practice nurse-supported cognitive behavioural therapy self-help attained similar clinical outcomes for similar costs and were more satisfied than patients treated by GPs with ordinary care. On-treatment analysis showed patients receiving the facilitated cognitive behavioural therapy self-help were more likely to be below clinical threshold at 1 month compared to the ordinary care group (odds ratio [OR] = 3.65, 95% confidence interval [CI] = 1.87 to 4.37). This difference was less well marked at 3 months (OR = 1.36, 95% CI = 0.52 to 3.56). CONCLUSION: Facilitated cognitive behavioural self-help may provide a short-term cost-effective clinical benefit for patients with mild to moderate anxiety and depression. This has the potential to help primary care provide a choice of effective psychological as well as pharmacological treatments for mental health problems.

Objective: to compare the workloads of general practitioners and nurses and costs of patient care for nurse telephone triage and standard management of requests for same day appointments in routine primary care. Design: Multiple interrupted time series using sequential introduction of experimental triage system in different sites with repeated measures taken one week in every month for 12 months. Setting: Three primary care sites in York. Participants: 4685 patients: 1233 in standard management, 3452 in the triage system. All patients requesting same day appointments during study weeks were included in the trial. Main outcome measures: Type of consultation (telephone, appointment, or visit), time taken for consultation, presenting complaints, use of services during the month after same day contact, and costs of drugs and same day, follow up, and emergency care. Results: the triage system reduced appointments with general practitioner by 29-44%. Compared with standard management, the triage system had a relative risk (95% confidence interval) of 0.85 (0.72 to 1.00) for home visits, 2.41 (2.08 to 2.80) for telephone care, and 3.79 (3.21 to 4.48) for nurse care. Mean overall time in the triage system was 1.70 minutes longer, but mean general practitioner time was reduced by 2.45 minutes. Routine appointments and nursing time increased, as did out of hours and accident and emergency attendance. Costs did not differ significantly between standard management and triage: mean difference £1.48 more per patient for triage (95% confidence interval -0.19 to 3.15). Conclusions: Triage reduced the number of same day appointments with general practitioners but resulted in busier routine surgeries, increased nursing time, and a small but significant increase in out of hours and accident and emergency attendance. Consequently, triage does not reduce overall costs per patient for managing same day appointments.

The PHASE research programme is an NHS-Executive funded, randomized controlled trial of assisted self-help for common mental disorders, delivered by practice nurses in primary care. The self-help guide - Managing anxiety and depression: a self-help guide published by the Mental Health Foundation - is conceptualized as a ‘health technology’ where the nurse's role is to educate patients how to get the best out of the technology, supervise its safe delivery and monitor its continued use by patients so that they can use it independently with little reliance on nurses or other health professionals. Twenty-three nurses were trained on one of five, 3-day courses to deliver PHASE. As the final task during the training course, nurses were asked to describe what they would say to a patient when delivering PHASE. From these data a qualitative thematic contentanalysis was used to develop a coding framework which showed that nurses were able to articulate a sophisticated health technology rationale, including relevant psychological models and the principle of an evidence base. This study demonstrates that it is possible to equip primary care nurses with both a highly developed understanding and the knowledge to deliver self-help mental health care. Training nurses using this model moves us away from traditional mental health training courses that have attempted to produce ‘watered down’ versions of specialist practitioners to a more appropriate skills and cultural ‘health technology’ fit for delivering primary mental health care. © 2002, Arnold. All rights reserved.

Historically, there have been many attempts to develop interventions to support the carers of people with dementia. To date the evidence of effectiveness has been limited. However, the success of psychosocial interventions for carers of people with schizophrenia has suggested the possibility of utilizing this approach. A systematic review was undertaken to assess the evidence of effectiveness for psychosocial interventions with carers of people with dementia. Thirty controlled trials that evaluated a psychosocial approach were identified. The overall methodological quality of these studies was poor, particularly with regard to sample size, and methods of random allocation. Individualized interventions that utilized problem solving and behaviour management demonstrated the best evidence of effectiveness. This approach is also closest to the effective model of psychosocial interventions currently in use with other severe and enduring illnesses. This suggests that there is scope for developing interventions, based more specifically on this model, for supporting the carers of people with dementia.

This special edition of Behavioural and Cognitive Psychotherapy is dedicated as a tribute to Isaac Marks, who retires this year from his post as Professor of Experimental Psychopathology at the Institute of Psychiatry, London. All the contributors to this edition are
colleagues who have been greatly influenced by Isaac during their careers. Their papers were written without Isaac knowing of our plans and we were even cheeky enough to ask Isaac to write a paper himself, reflecting on his 40 years involvement in the development of behavioural and cognitive psychotherapies. All the papers, including the one by Isaac himself, illustrate some of the areas where
he has made a major contribution to behavioural and cognitive psychotherapies during the last 40 years.Two papers, by Hand and by Rowa, Antony and Swinson, detail the huge advances made in the treatment of the severe and disabling disorders of agoraphobia and OCD, identifying Isaac's enormous contribution. The papers also confirm the international scope of Isaac's influence. These authors
remind us not to forget the relative modernity of effective psychological treatments for these disorders and how dramatic a change there has been in prognosis and clinical outcomes.

Anxiety and depression are prevalent in primary care; however, current treatments differ in their availability, cost-effectiveness, and acceptability to patients. Self-help treatments (such as manual-based bibliotherapy) may be an appropriate intervention for some patients. The aim of this research was to determine the clinical and cost-effectiveness of self-help treatments for anxiety and depression in primary care by conducting a systematic review of randomised and non-randomised trials of self-help interventions for patients with anxiety and depression in primary care, from electronic database searches, correspondence with authors, and limited handsearching. Eight studies were identified, examining written interventions based mostly on behavioural principles. Although the majority of trials reported some significant advantages in outcome associated with self-help treatments, the number of included studies was limited and a number of methodological limitations were identified. There were no data concerning long-term clinical benefits or cost-effectiveness. In conclusion, self-help treatments may have the potential to improve the overall cost-effectiveness of mental health service provision. However, the available evidence is limited in quantity and quality and more rigorous trials are required to provide more reliable estimates of the clinical and cost-effectiveness of these treatments.

In this article, the authors describe the changes required to introduce a nurse telephone triage system into a large primary care practice in York. 'Whole systems' changes were necessary in that not one element of the primary healthcare team (PHCT) system has remained unaffected. The introduction of nurse triage has changed working practices, professional working relationships and job satisfaction. Far from being just a workload management solution, it has fundamentally altered the way that nurses, doctors and reception staff work together and with patients.

Objective: to examine how community psychiatric nurses (CPNs) in a nurse-led system for dealing with referrals to community mental health teams (CMHTs) from primary care prioritized referrals. Design: a retrospective survey of patients' assessment records. Setting: Four CMHTs in Salford which provide specialist mental health care for the adult population (16-65 age group). Participants: a cohort of 874 patients referred by GPs and seen by CPNs for initial assessment. Measures: Referral outcome, demographic characteristics, general ICD-10 diagnosis and the Health of the Nation Outcome Scales. Results: Access to support appeared to be restricted to patients with diagnosable disorders, as opposed to sub-threshold problems of living. Three main factors were identified which explained how patients were prioritized: diagnosis; previous history; and the severity of their presenting problems. Conclusion: the findings suggested that providing a single gateway to the CMHT may help to clarify the referral process and help to manage the demand for care at the primary care/CMHT interface. © 2000 Harcourt Publishers Ltd.

The fundamental role of primary health care teams (PHCT) is to deliver effective services to the local population. Demands on the PHCT have increased since the early 1990s and, with the advent of Primary Care Groups (PCGs), will continue to do so in a primary health care led National Health Service (NHS). Rapid changes, however, raise questions about the feasibility and delivery of new services with skill mix and the distribution of workload within the PHCT being key issues. This paper reviews the literature on workload in primary care, attitudes to delegation, inter-professional relationships and teamworking and concludes that in order to deliver the vision of a primary care led NHS, meet the health care needs of users, address the inevitable anxieties of general practitioners and bring forth the professional aspirations of nurses and other health care professionals, more equitable and less hierarchical models of multi-professional teamworking in primary care will be most successful. © 2000 Elsevier Science Ltd. All rights reserved.

OBJECTIVES: to investigate the relative importance of personal and social variables on post-trauma symptom recovery. DESIGN: Prospective survey of armed robbery victims. METHODS: Fifty-one consecutive armed robbery victims were assessed immediately and at 1 month post-raid for post-traumatic stress. One month post-raid, crisis support, causal attribution and coping were also measured. Thirty-one of the sample were assessed for symptoms 6 months after the raid. RESULTS: Both the main and follow-up samples had high levels of post-traumatic stress symptoms immediately after the raid which reduced significantly 1 month later and, for the follow-up subsample, further still 6 months later. Higher levels of symptoms at 1 month and poor crisis support were associated with higher levels of symptoms at follow-up. CONCLUSIONS: Purposeful coping, symptom severity and social support effect post-trauma recovery.

BACKGROUND: General psychiatrists have recently been encouraged to provide treatment to heroin addicts, including in-patient detoxification. No comparison has previously been made of specialist versus general psychiatric in-patient care. METHOD: During a randomised study of cue exposure, 186 opiate addicts were also randomised to either specialist in-patient (DDU; n = 115) or general psychiatric (GEN; n = 71) wards in the same hospital. RESULTS: from pre-treatment (post-randomisation) onwards, patient outcomes differed across the two in-patient settings. of the original randomised sample, significantly more DDU than GEN subjects accepted their randomisation (100 v. 77%), were subsequently admitted (60 v. 42%), and completed in-patient detoxification (45 v. 18%). of patients admitted, more DDU than GEN patients completed detoxification (75 v. 43%). During seven-month follow-up, of those 43 patients who reached the end of treatment, significantly more ex-DDU than ex-GEN subjects were opiate-free. CONCLUSIONS: from pre-treatment onwards, significant differences in process and outcome were found after allocation to treatment on either DDU or GEN. Further randomised studies are required to replicate and explain these findings.

Post-traumatic stress disorder (PTSD) is increasingly becoming recognised as a serious mental health problem (Department of Health, 1991). Psychological treatments for PTSD remain in their infancy, though limited research has demonstrated the efficacy of behavioural and cognitive-behavioural interventions.

The relative values of imaginal and real-life exposure exercises were tested in this study by randomizing 14 patients who met DSM-III-R criteria for PTSD at least 6 months after the initiating trauma to one of two groups. Group 1 (n=7) had four, weekly, hour-long sessions of imaginal exposure followed by four, weekly, hour-long sessions of live exposure. Group 2 (n=7) had the reverse order of four live exposure sessions followed by four imaginal exposure sessions. Both groups improved significantly on both PTSD-specific measures and measures of general health post-treatment, and significantly further on 7 out of 12 measures at follow up 12 months post-treatment. Clinical improvement was in the order of 65-80% reduction in target symptoms. On one measure only (problem 2 - phobic avoidance), live exposure yielded more improvement than imaginal exposure whether given first or second. The importance of both live and imaginal exposure to all relevant cues, behavioral and cognitive, is discussed, together with the value of self-exposure homework for patients with PTSD. © 1994 Plenum Publishing Corporation.

Given the high relapse rate of opiate addicts following detoxification, it is pertinent to identify whether any subjective variables mediate outcome, since these may then be targets of treatment. The present study assessed personality, cue-elicited craving, outcome expectancies for drug use, and self-efficacy for resisting drug use, in 43 opiate addicts receiving inpatient detoxification in either a specialist drug-dependence unit or a behavioral/general psychiatric ward, within the context of a randomised, controlled-treatment trial. Subjects were followed-up at between 1 and 3 months and again at 6 months after discharge. Frequency of drug use was not predicted by any of the subjective variables at the first follow-up; but at 6 months, subjects with lower self-efficacy and higher positive outcome expectancies were found to be using less often. Latency to first lapse was greater in subjects with higher anxiety and neuroticism scores. Precipitants to the first lapse were identified, but none of the predicted relationships between subjective variables and circumstances of lapse emerged. It is suggested that greater awareness of personal vulnerability may promote effective coping strategies.

In health care training, professional examinations of competence test trainees' knowledge rather than their actual contribution to the improvement of patients' health. Clinical training programmes have the ultimate aim of improving patients' health, but rarely measure their success in attaining it. This paper provides an analysis of the results of clinical outcome for 2,032 patients treated during eight consecutive English National Board 650 courses, in which 68 nurse behaviour therapist trainees were trained at the Maudsley Hospital from 1978-91. The outcome of 668 patients treated in three recent courses (1987-91) is compared with that of 1,384 patients treated in five earlier courses (1978-86). Measures and diagnostic categories were similar over the whole study period. The trainees in 1987-91 achieved a similar health gain for most of their patients as did their counterparts in 1979-86, but this was achieved over a shorter time spent with each patient, and with greater effect in patients diagnosed as obsessive ruminators. These efficiency gains seem to reflect the incorporation into recent training of treatment advances in anxiety disorders.

A controlled trial studied whether cue exposure prevented relapse in opiate addiction. Subjects were randomly allocated to one of two inpatient treatment settings: a drug dependence unit with a special 10 week program and 4 weeks in a behavioural/general treatment unit without such a program. In each setting, following drug-withdrawal, subjects had either cue exposure for at least six sessions over 3 weeks, or a control condition. Subjects were followed up twice, at about 6 weeks and 6 months post-treatment. 186 subjects were randomly allocated; 69 were assessed post-detoxification, and of these 43 completed cue exposure or control treatments. Cue exposure and control subjects did not differ in cue reactivity. This was evaluated post-treatment for cue exposure subjects and at a comparable time point for controls. All groups showed a significant decrement in cue-elicited craving, withdrawal responses and negative mood. Cue exposure and control subjects did not differ at either of the two follow up interviews.

Four cases of PTSD, and their treatment, are described. Symptoms responded differently to two beavioural approaches. In-vivo exposure was effective for phobic anxiety while imaginal exposure improved dysphoria and some phobic symptoms. Audio-taped imaginal exposure may be important as part of treatment.

A severe phobia of snakes was treated by exposure in imagination, no in vivo exposure taking place. Imaginal exposure homework was given with the aid of audio-tapes of the treatment sessions. After treatment, in a behavioural test, the client experienced rapid habituation of anxiety to handling a live snake. The total amount of time taken for the treatment was similar to the time taken in treating other small animal phobics by in vivo exposure alone. It is suggested that for specific phobics the use of imaginal rehearsal prior to in vivo exposure may optimise the conditions under which in vivo exposure takes places and require no more of the therapist's time than the usual in vivo methods. © 1988, British Association for Behavioural and Cognitive Psychotherapies. All rights reserved.