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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

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

Authors

Andrew Gibson

Suzanne H. Richards

Chris Dickens

Rob Anderson

David A. Richards

Rod S. Taylor

Obioha C. Ukoumunne

David Kessler

Katrina Turner

Willem Kuyken

Manish Gandhi

Luke Knight

Andy Gibson Andy.Gibson@uwe.ac.uk
Associate Professor in Patient and Public Involve

Antoinette Davey

Fiona Warren

Rachel Winder

Christine Wright

John Campbell



Abstract

© 2016 Richards et al. Background: Around 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/Design: This 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. Discussion: The 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 registration:ISRCTN34701576(Registered 29 May 2014)

Citation

Gibson, A., Richards, S. H., Dickens, C., Anderson, R., Richards, D. A., Taylor, R. S., …Campbell, J. (2016). 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. Trials, 17(1), https://doi.org/10.1186/s13063-016-1184-9

Journal Article Type Article
Acceptance Date Jan 16, 2016
Publication Date Feb 2, 2016
Journal Trials
Print ISSN 1745-6215
Electronic ISSN 1745-6215
Publisher BMC
Peer Reviewed Peer Reviewed
Volume 17
Issue 1
DOI https://doi.org/10.1186/s13063-016-1184-9
Keywords depression, coronary heart disease, multimorbidity, behavioural activation, mental health care coordination, cardiac rehabilitation, randomised controlled trial, qualitative interviews
Public URL https://uwe-repository.worktribe.com/output/914298
Publisher URL http://dx.doi.org/10.1186/s13063-016-1184-9

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