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Open Access Study protocol

A written self-help intervention for depressed adults comparing behavioural activation combined with physical activity promotion with a self-help intervention based upon behavioural activation alone: study protocol for a parallel group pilot randomised controlled trial (BAcPAc)

Paul Farrand1*, Claire Pentecost1, Colin Greaves2, Rod S Taylor2, Fiona Warren2, Colin Green2, Melvyn Hillsdon3, Phil Evans2, Jo Welsman4 and Adrian H Taylor5

Author Affiliations

1 Mood Disorders Centre, School of Psychology, Washington Singer Laboratories, University of Exeter, Perry Road, Exeter EX4 4QG, UK

2 University of Exeter Medical School, Heavitree Road, Exeter EX1 2LU, UK

3 Sport & Health Sciences, University of Exeter, Heavitree Road, Exeter EX1 2LU, UK

4 Lived Experience Group, Clinical Education Development and Research and Mood Disorders Centre, School of Psychology, Washington Singer Laboratories, University of Exeter, Perry Road, Exeter EX4 4QG, UK

5 Plymouth University Peninsula Schools of Medicine & Dentistry, John Bull Building, Research Way, Plymouth, Devon PL6 8BU, UK

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Trials 2014, 15:196  doi:10.1186/1745-6215-15-196

Published: 29 May 2014

Abstract

Background

Challenges remain to find ways to support patients with depression who have low levels of physical activity (PA) to overcome perceived barriers and enhance the perceived value of PA for preventing future relapse. There is an evidence-base for behavioural activation (BA) for depression, which focuses on supporting patients to restore activities that have been avoided, but practitioners have no specific training in promoting PA. We aimed to design and evaluate an integrated BA and PA (BAcPAc) practitioner-led, written, self-help intervention to enhance both physical and mental health.

Methods/design

This study is informed by the Medical Research Council Complex Intervention Framework and describes a protocol for a pilot phase II randomised controlled trial (RCT) to test the feasibility and acceptability of the trial methods to inform a definitive phase III RCT. Following development of the augmented written self-help intervention (BAcPAc) incorporating behavioural activation with physical activity promotion, depressed adults are randomised to receive up to 12 sessions over a maximum of 4 months of either BAcPAc or behavioural activation alone within a written self-help format, which represents treatment as usual. The study is located within two ‘Improving Access to Psychological Therapies’ services in South West England, with both written self-help interventions supported by mental health paraprofessionals. Measures assessed at 4, 9, and 12 month follow-up include the following: CIS-R, PHQ-9, accelerometer recorded (4 months only) and self-reported PA, body mass index, blood pressure, Insomnia Severity Index, quality of life, and health and social care service use. Process evaluation will include analysis of recorded support sessions and patient and practitioner interviews. At the time of writing the study has recruited 60 patients.

Discussion

The feasibility outcomes will inform a definitive RCT to assess the clinical and cost-effectiveness of the augmented BAcPAc written self-help intervention to reduce depression and depressive relapse, and bring about improvements across a range of physical health outcomes.

Trial registration

Current Controlled Trials ISRCTN74390532, 26.03.2013.

Keywords:
Behavioural activation; Cognitive behavioural therapy; Depression; Paraprofessional; Physical activity promotion; Physical health; Pilot randomised controlled trial; Self-help