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.
Bibliographical noteFunding Information:
BAcPAc is funded by the NPRI-4 (Medical Research Council and partners: Alzheimer’s Research Trust, Alzheimer’s Society, Biotechnology and Biological Sciences Research Council, British Heart Foundation, Cancer Research UK, Chief Scientist Office-Scottish Government Health Directorate, Department of Health, Diabetes UK, Economic and Social Research Council, Engineering and Physical Sciences Research Council, Health and Social Care Research Division, Public Health Agency, Northern Ireland, Stroke Association, Wellcome Trust, Welsh Government, World Cancer Research Fund) and has been adopted onto the NIHR, portfolio number NIHR 13288. We would like to thank the external members of the Trial Steering Committee (TSC) for their expert advice and support for the project: Professor Nanette Mutrie (University of Edinburgh), Dr Nicola Wiles (University of Bristol), Nick Turner (University of Bristol), and Professor Chris Williams (University of Glasgow). Gavin Malloch (MRC – NPRI Manager) also attended the TSC on behalf of the funding body. However, aside from this involvement neither he, the funders, nor the sponsor had any role in the design of this study, analyses, data interpretation, or in the decision to submit results for publication. A data monitoring committee was not required for this study given its pilot status. We are also grateful to the Psychological Wellbeing Practitioners for their time in attending training and delivering the BA as usual or BAcPAc intervention for patients in the IAPT Services, and the support provided by the Service Managers and Administrators who provided valuable assistance to us throughout the study, and finally Julia Scarle for providing administrative support for the research. Lastly, we are very grateful to the participants who supported the study, giving so generously of their time and sharing their experiences with us.
This study is sponsored by Gail Seymour, Research and Knowledge Transfer, University of Exeter; email@example.com.
- Behavioural activation
- Cognitive behavioural therapy
- Physical activity promotion
- Physical health
- Pilot randomised controlled trial
ASJC Scopus subject areas
- Medicine (miscellaneous)
- Pharmacology (medical)