Feasibility and acceptability of an enhanced psychological care intervention within cardiac rehabilitation services for patients with new-onset depressive symptoms compared to treatment as usual

The CADENCE study aims to develop and assess the feasibility and acceptability of an enhanced psychological care (EPC) intervention within cardiac rehabilitation services for patients with new-onset depressive symptoms, compared to treatment as usual.

The project is a collaboration between the University of Exeter, the University of Bristol, and the Royal Devon & Exeter NHS Foundation Trust. It is funded by the National Institute for Health Research (NIHR), Health Technology Assessment (HTA) funding stream. The Royal Devon and Exeter NHS Foundation Trust is acting as Sponsor.

A favourable ethical opinion has been obtained from the NRES Committee South West – Exeter (reference: 14/SW/0139). The study has ISRCTN registration (reference: 34701576) and[WC1]  has been adopted by the UK Comprehensive Research Network (UKCRN ID: 17105.

The study will consist of two phases – a feasibility study and a pilot cluster randomised controlled trial (RCT). A mixed methods approach will be used to assess the feasibility and acceptability of the EPC intervention to NHS cardiac rehabilitation nurses and to patients who experience depressive symptoms following an acute cardiac event. This will include documenting ‘process information’ (e.g. patient flow through cardiac rehabilitation services and numbers of patients eligible for and recruited into the study), describing the socio-demographic characteristics of participating patients, conducting in-depth interviews with cardiac rehabilitation nurses and patients, and observing the delivery of EPC within participating cardiac rehabilitation services.

In the feasibility study, the research team will develop, pilot and evaluate the EPC intervention, and test out the proposed pilot RCT methods with three cardiac rehabilitation teams in Devon and 20 patients. All nurses will be trained to deliver EPC to patients with depressive symptoms who are referred to their cardiac rehabilitation programme. The EPC intervention will consist of two evidence-based non-drug components: behavioural activation and mental health care coordination.

In the pilot RCT, a further eight cardiac rehabilitation teams across the South West of England will be recruited and randomised to deliver to patients who are experiencing depressive symptoms either the EPC intervention or standard psychological care (‘treatment as usual’) within their cardiac rehabilitation programme.

Core research team

Professor John Campbell – Professor of General Practice & Primary Care, UEMS – Chief Investigator

Dr Suzanne Richards – Senior Lecturer, UEMS – Overall Scientific Lead

Mrs Antoinette Davey - UEMS, Research Fellow (Quantitative)

Ms Rachel Winder – UEMS, Research Fellow (Qualitative)

Ms Julie Chudley – UEMS, Study Administrator

Dr Fiona Warren – UEMS, Lecturer in Medical Statistics

 

Co-investigators

Dr Manish Gandhi – Consultant Cardiologist, Royal Devon & Exeter NHS Foundation Trust (Principal Investigator)

Ms Rebecca Chawner – Cardiology Nurse Specialist, Royal Devon & Exeter NHS Foundation Trust

Professor Chris Dickens – Professor of Psychological Medicine, UEMS

Professor David Richards – Professor of Mental Health Services Research, UEMS

Professor Willem Kuyken – Professor of Clinical Psychology, Mood Disorders Centre, University of Exeter

Dr Katrina Turner – Senior Lecturer in Primary Health Care, University of Bristol (Qualitative Lead)

Dr David Kessler – Consultant Senior Lecturer, University of Bristol

Professor Rod Taylor – Professor of Health Services Research, UEMS

Professor Rob Anderson – Associate Professor, Health Economics and Evaluation, UEMS

Dr Obi Ukoumunne – Senior Lecturer in Medical Statistics, UEMS

Dr Andy Gibson – Research Fellow in Patient and Public Involvement, UEMS

 

Study sites:

Feasibility phase (July 2014 to March 2015) – Royal Devon and Exeter NHS Foundation Trust and Northern Devon Healthcare NHS Trust

Pilot trial phase (June 2015 to July 2016) – South Devon Health Care NHS Foundation Trust, Taunton and Somerset NHS Foundation Trust, Somerset Partnership NHS Foundation Trust, Yeovil District Hospital NHS Foundation Trust, Royal Cornwall Hospitals NHS Trust, Weston Area Health NHS Trust, University Hopsitals Bristol NHS Foundation Trust, and University Hopsitals Coventry and Warwickshire NHS Trust.

 

Study dates: April 2014 to July 2016

 

Funding: £448,288 – National Institute for Health Research (NIHR), Health Technology Assessment (HTA) funding stream

 

Location:

University of Exeter Medical School (Primary Care), Smeall Building, St Luke’s Campus, Exeter, EX1 2LU

Tel: 01392 722742

Fax: 01392 722894

Contact: Dr Suzanne Richards