Assessing the effectiveness of enhanced psychological care for patients with depressive symptoms attending cardiac rehabilitation compared with treatment as usual (CADENCE): study protocol for a pilot cluster randomised controlled trial.

Antoinette Davey,John Campbell,Obioha C Ukoumunne,Suzanne H Richards,Christine Wright,Rod S Taylor,Chris Dickens,Andrew Gibson,David Kessler,Luke Knight,Rachel Winder,David A Richards,Rob Anderson,Katrina Turner,Willem Kuyken,Fiona Warren,Manish Gandhi

doi:10.1186/s13063-016-1184-9

Abstract

BackgroundAround 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/DesignThis 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.DiscussionThe 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 registrationISRCTN34701576 (Registered 29 May 2014)Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1184-9) contains supplementary material, which is available to authorized users.

Highlights

Around 17 % of people eligible for UK cardiac rehabilitation programmes following an acute coronary syndrome report moderate or severe depressive symptoms
Qualitative and observational data, considered along with findings arising from discussions with lay representatives, identified the need to reduce the intensity of the Behavioural Activation (BA) component of the enhanced psychological care intervention (EPC) delivered by cardiac rehabilitation (CR) nurses operating within the context of routine care
The EPC intervention to be delivered in the pilot study will retain the nurse acting as a mental health care coordinator, using clearly defined clinical decisionmaking points and applying evidence-based referral pathways, with the BA component delivered as a participant-led BA intervention, actively supported by the CR nurse

Summary

Introduction

Around 17 % of people eligible for UK cardiac rehabilitation programmes following an acute coronary syndrome report moderate or severe depressive symptoms. Prevalence of depression and associated outcomes for patients with acute coronary syndromes Major depression is common among people with coronary heart disease. Rates of depression have been shown to be elevated in individuals following coronary artery bypass grafting [2], patients with unstable angina [3] and patients with chronic heart failure [4]. These rates greatly exceed those seen in the UK general population (2.6 % [5]), suggesting that the associations between coronary disease and depression may be causal (direct or indirect). Mechanisms underpinning the association between depressive symptoms and poor cardiovascular outcomes may include biological and behavioural processes, or may be confounded by shared genetic vulnerability, environmental stresses, or perseverative negative cognitive processes [12]

Objectives

Methods

Findings

Conclusion