title: 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.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN34701576 (Registered 29 May 2014).
authors.affiliation: University of Exeter Medical School, St Luke's Campus, Exeter, EX1 2LU, UK. s.h.richards@exeter.ac.uk.
authors.forename: Suzanne H
authors.initials: SH
authors.lastname: Richards
authors.affiliation: University of Exeter Medical School, St Luke's Campus, Exeter, EX1 2LU, UK. c.m.dickens@exeter.ac.uk.
authors.forename: Chris
authors.initials: C
authors.lastname: Dickens
authors.affiliation: University of Exeter Medical School, St Luke's Campus, Exeter, EX1 2LU, UK. r.anderson@exeter.ac.uk.
authors.forename: Rob
authors.initials: R
authors.lastname: Anderson
authors.affiliation: University of Exeter Medical School, St Luke's Campus, Exeter, EX1 2LU, UK. d.a.richards@exeter.ac.uk.
authors.forename: David A
authors.initials: DA
authors.lastname: Richards
authors.affiliation: University of Exeter Medical School, St Luke's Campus, Exeter, EX1 2LU, UK. r.taylor@exeter.ac.uk.
authors.forename: Rod S
authors.initials: RS
authors.lastname: Taylor
authors.affiliation: NIHR Collaboration for Leadership in Applied Health Research and Care for the South West Peninsula, University of Exeter Medical School, St Luke's Campus, Exeter, EX1 2LU, UK. o.c.ukoumunne@exeter.ac.uk.
authors.forename: Obioha C
authors.initials: OC
authors.lastname: Ukoumunne
authors.affiliation: School of Social and Community Medicine, University of Bristol, Oakfield House, Oakfield Grove, Clifton, Bristol, BS8 2BN, UK. david.kessler@bristol.ac.uk.
authors.forename: David
authors.initials: D
authors.lastname: Kessler
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, Whatley Road, Bristol, BS8 2PS, UK. katrina.turner@bristol.ac.uk.
authors.forename: Katrina
authors.initials: K
authors.lastname: Turner
authors.affiliation: University Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, 0X3 7JX, UK. willem.kuyken@psych.ox.ac.uk.
authors.forename: Willem
authors.initials: W
authors.lastname: Kuyken
authors.affiliation: Royal Devon and Exeter NHS Foundation Trust, Barrack Road, Exeter, EX2 5DW, UK. manish.gandhi@nhs.net.
authors.forename: Manish
authors.initials: M
authors.lastname: Gandhi
authors.affiliation: Royal Devon and Exeter NHS Foundation Trust, Barrack Road, Exeter, EX2 5DW, UK. luke.knight@nhs.net.
authors.forename: Luke
authors.initials: L
authors.lastname: Knight
authors.affiliation: Health and Social Sciences, University of the West of England, Frenchay Campus, Coldharbour Lane, Bristol, BS16 1QY, UK. andy.gibson@uwe.ac.uk.
authors.forename: Andrew
authors.initials: A
authors.lastname: Gibson
authors.affiliation: University of Exeter Medical School, St Luke's Campus, Exeter, EX1 2LU, UK. antoinette.davey@exeter.ac.uk.
authors.forename: Antoinette
authors.initials: A
authors.lastname: Davey
authors.affiliation: University of Exeter Medical School, St Luke's Campus, Exeter, EX1 2LU, UK. f.c.warren@exeter.ac.uk.
authors.forename: Fiona
authors.initials: F
authors.lastname: Warren
authors.affiliation: University of Exeter Medical School, St Luke's Campus, Exeter, EX1 2LU, UK. r.e.winder@exeter.ac.uk.
authors.forename: Rachel
authors.initials: R
authors.lastname: Winder
authors.affiliation: University of Exeter Medical School, St Luke's Campus, Exeter, EX1 2LU, UK. c.a.wright@exeter.ac.uk.
authors.forename: Christine
authors.initials: C
authors.lastname: Wright
authors.affiliation: University of Exeter Medical School, St Luke's Campus, Exeter, EX1 2LU, UK. john.campbell@exeter.ac.uk.
authors.forename: John
authors.initials: J
authors.lastname: Campbell
mesh_terms: D054058:Acute Coronary Syndrome / Q000523:psychology / Q000534:rehabilitation*; D000928:Antidepressive Agents / Q000627:therapeutic use; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003362:Cost-Benefit Analysis; D003625:Data Collection; D003863:Depression / Q000628:therapy*; D006801:Humans; D017063:Outcome Assessment, Health Care; D061214:Patient Safety; D018579:Patient Selection; D010865:Pilot Projects; D036301:Qualitative Research; D018401:Sample Size
chemical_list: D000928:Antidepressive Agents
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