A third of heart disease patients attending cardiac rehabilitation also suffer from depression or anxiety, yet the psychological support they receive often fails to help them. This matters because standard treatments—medication and conventional talking therapies—have limited effectiveness for this group, and NHS cardiac rehabilitation services rarely deliver the kind of psychological care that works. The research team has developed a different approach called metacognitive therapy, which trains patients to change how they react to anxious or depressed thoughts rather than challenging the thoughts themselves. They will test a group version of this therapy in a pilot trial, then a full-scale trial, and also develop a home-based version for patients who cannot attend group sessions. If successful, the programme would give heart patients a genuine choice between two evidence-based psychological interventions integrated directly into their cardiac rehabilitation pathway. That could improve not only their mental health but also their physical recovery and quality of life, while potentially reducing NHS costs by cutting repeat hospital visits and long-term medication use.
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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
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