Abstract

BackgroundAround 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.MethodsAn 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.ResultsEight 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.DiscussionWhile 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 registrationISRCTN34701576. Registered on 29 May 2014.Funding details: UK NIHR HTA Programme (project 12/189/09).

Highlights

  • Around 17% of people attending United Kingdom (UK) cardiac rehabilitation programmes have depression

  • To improve access to evidence-based psychological treatment for depression among people attending cardiac rehabilitation, we developed and conducted a preliminary evaluation of a complex intervention (Enhanced Psychological Care or ‘EPC’) for delivery by cardiac rehabilitation nurses alongside routine cardiac rehabilitation

  • Teams were randomised (five to EPC and three to usual care (UC)), with one team withdrawing from the EPC arm immediately post randomisation

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Summary

Objectives

Our aim was to pilot the methods and procedures required to undertake a fully powered evaluation of the clinical effectiveness and cost-effectiveness of implementing EPC for patients with new-onset depressive symptoms using cardiac rehabilitation compared with treatment as usual [22]. Settings and study population We aimed to recruit and randomise eight cardiac rehabilitation teams

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