Title: Improving the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway (PATHWAY)
Funder: Department of Health and Social Care

Abstract: Patient and public involvement (PPI) Dr Williamson, an INVOLVE member (2004-2012) and NIHR Research Design Service North West PPI adviser, will lead all PPI components. A service user advisory group will meet quarterly, providing input to all work streams. A service-user co-applicant will act as a conduit between the research team and the advisory group. A detailed within-project evaluation of the PPI components will help refine our approach and add to the evidence-base for public involvement in research. Aims and objectives Our primary aim is to improve access to more effective psychological interventions for the range of heart disease patients attending cardiac rehabilitation (CR) services. Specific objectives are to: (1) Conduct a pilot randomised controlled trial of a group metacognitive intervention (Group-MCT) for patients with depression and/or anxiety. (2) Establish evidence of the effectiveness/cost-effectiveness of Group-MCT in a full-scale randomised controlled trial (3) Produce a rigorous, well-specified Group-MCT package (4) Develop a home-based metacognitive intervention (Home-MCT) for patients with depression and/or anxiety (5) Establish the feasibility and acceptability of integrating Home-MCT into the CR pathway in a feasibility randomised controlled trial (6) Establish provisional evidence of the effectiveness/cost-effectiveness of Home-MCT (7) Develop a protocol/manual for Home-MCT to inform a full-scale randomised controlled trial Background and rationale Depression/anxiety are highly prevalent in people with heart disease, causing immense human and economic burden. Available pharmacological and psychological interventions have limited efficacy and the needs of these patients are not being met in CR services despite emphasis in key NHS policy; the Department of Health s (2010) Cardiac Rehabilitation Commissioning Pack specifies a seven-stage care pathway in which psychological assessment and support are advocated throughout. We will integrate two metacognitive interventions for patients with depression and/or anxiety into the CR pathway: a group intervention and a home-based intervention. This will provide choice to patients and is consistent with NHS guidance which recommends a menu-based approach to widen uptake and participation in CR. The programme will lead to better informed and integrated care with the potential to improve psychological, physical and economic outcomes for heart disease patients. Research plan The programme comprises three work streams: Work stream 1 (WS1) is a pilot trial of Group-MCT for patients with depression and/or anxiety. Work stream 2 (WS2) is a full-scale randomised controlled trial to evaluate the effectiveness and cost-effectiveness of Group-MCT plus usual care compared to usual care alone. Work stream 3 (WS3) will develop Home-MCT for patients with depression and/or anxiety and evaluate the acceptability and feasibility of integrating the intervention into the CR pathway in a feasibility trial. Dissemination and projected outputs We will engage with healthcare planners, practitioners and policy makers regionally and nationally including NHS England Strategic Clinical Networks and Senate - Greater Manchester, Lancashire and South Cumbria, NHS Improvement Body and the British Association of Cardiovascular Prevention and Rehabilitation to ensure maximum uptake of programme outputs. A dissemination and impact plan will be developed at study outset and overseen by a dissemination group which meets six-monthly. A programme website will provide up-to-date information in an accessible format. A full and summary final report will be made available in paper and online versions. We will present findings at cardiovascular, psychological therapies and public involvement conferences as well as local conferences and forums. Projected outputs include two user-informed psychological interventions for depression and anxiety (Group-MCT and Home-MCT); evidence of the effectiveness and cost-effectiveness of Group-MCT; a rigorous, well-specified Group-MCT package; evidence of the acceptability/feasibility of Home-MCT; preliminary evidence of the effectiveness/cost-effectiveness of Home-MCT; a manual/protocol for Home-MCT to inform a full-scale randomised controlled trial. Expertise and experience of the team Our team comprises members with expertise in clinical psychology, cardiology, statistics, health economics, qualitative evaluation, PPI and NHS management. We have a history of successful collaboration on previous research. The team has expertise in all areas necessary for programme success as evidenced in our track record of externally-funded research, psychological treatment manuals in widespread NHS use, over 1000 publications, and recommendation of our research and treatments in national and international guidelines for mental health and physical health conditions. Management and governance A steering committee, meeting six-monthly, will oversee the programme. An executive committee comprising all applicants and the programme manager will meet bimonthly. Multicentre ethics approval and local governance permissions will be obtained and the programme will be conducted within NHS and professional ethical guidelines. Manchester Academic Health Sciences Clinical Trials Co-Ordination Unit (MAHSC-CTU) will have responsibility for data management and on-site monitoring. Participants will provide written informed consent. Data will be held securely and anonymously. Justification of costs The majority of funding requested is for research staff, the time commitment of co-applicants and MAHSC-CTU involvement. Additional costs are detailed in the finance section.

Lay abstract: Cardiac rehabilitation (CR) services aim to improve heart disease patients health and quality of life, and reduce the risk of further cardiac events. Approximately 69,000 patients attend CR annually in the UK across 372 CR programmes. Depression and anxiety (distress) are common among CR patients: 37% of patents have significant anxiety and/or depressive symptoms. Distressed patients are at greater risk of death, further cardiac events and poorer quality of life than those without distress and they use more healthcare, leading to greater NHS costs. Therefore, distress is an important problem for both people with heart disease and the NHS. Available drug and psychological treatments have only small effects on distress and quality of life, and no effects on physical health. Furthermore, the needs of people with heart disease who have depression and anxiety are not being met by the NHS despite the treatment of emotional distress being emphasised in key NHS policy. Therefore, it is essential that more effective treatments for depression and anxiety are integrated into CR services. Extensive evidence shows that a particular style of thinking dominated by rumination (dwelling on the past) and worry maintains emotional distress. A psychological intervention (metacognitive therapy) that reduces this style of thinking alleviates depression and anxiety in mental health settings. We aim to integrate two versions of this intervention into CR services: a group intervention and a home-based intervention. This will provide choice to patients and is consistent with NHS policy which recommends a menu-based approach to widen uptake and participation in CR. The programme will lead to better informed and integrated care with the potential to improve psychological and physical wellbeing as well as reduce NHS costs. The programme has three work streams which will be undertaken at four NHS trusts. In work stream 1, we will conduct a pilot trial of the group intervention and in work stream 2 we will undertake a full-scale trial to evaluate whether adding the group intervention to standard CR is more effective at alleviating anxiety and depression than standard CR alone. In work stream 3, we will develop the home-based intervention and then evaluate how feasible it is to integrate the intervention into existing CR services and whether the intervention is acceptable to patients. There will be a service user group which will advise the research team and the programme will be undertaken in consultation with patients and relevant health professionals. The research team will build on its proven track record of developing effective psychological interventions for depression and anxiety in mental and physical health settings and integrating these into NHS services.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: CARDIOVASCULAR;MENTAL HEALTH