Behavioural Activation Therapy for Depression after Stroke (BEADS): a study protocol for a feasibility randomised controlled pilot trial of a psychological intervention for post-stroke depression

Thomas, Shirley A.; Coates, Elizabeth; das Nair, Roshan; Lincoln, Nadina B.; Cooper, Cindy; Palmer, Rebecca; Walters, Stephen J.; Latimer, Nicholas R.; England, Timothy J.; Mandefield, Laura; Chater, Timothy; Callaghan, Patrick; Drummond, Avril E. R.

Abstract

Background

There is currently insufficient evidence for the clinical and cost-effectiveness of psychological therapies for treating post-stroke depression.
Methods/Design

BEADS is a parallel group feasibility multicentre randomised controlled trial with nested qualitative research and economic evaluation. The aim is to evaluate the feasibility of undertaking a full trial comparing behavioural activation (BA) to usual stroke care for 4 months for patients with post-stroke depression. We aim to recruit 72 patients with post-stroke depression over 12 months at three centres, with patients identified from the National Health Service (NHS) community and acute services and from the voluntary sector. They will be randomly allocated to receive behavioural activation in addition to usual care or usual care alone. Outcomes will be measured at 6 months after randomisation for both participants and their carers, to determine their effectiveness. The primary clinical outcome measure for the full trial will be the Patient Health Questionnaire-9 (PHQ-9). Rates of consent, recruitment and follow-up by centre and randomised group will be reported. The acceptability of the intervention to patients, their carers and therapists will also be assessed using qualitative interviews. The economic evaluation will be undertaken from the National Health Service and personal social service perspective, with a supplementary analysis from the societal perspective. A value of information analysis will be completed to identify the areas in which future research will be most valuable.
Discussion

The feasibility outcomes from this trial will provide the data needed to inform the design of a definitive multicentre randomised controlled trial evaluating the clinical and cost-effectiveness of behavioural activation for treating post-stroke depression.

Citation

Thomas, S. A., Coates, E., das Nair, R., Lincoln, N. B., Cooper, C., Palmer, R., Walters, S. J., Latimer, N. R., England, T. J., Mandefield, L., Chater, T., Callaghan, P., & Drummond, A. E. R. (2016). Behavioural Activation Therapy for Depression after Stroke (BEADS): a study protocol for a feasibility randomised controlled pilot trial of a psychological intervention for post-stroke depression. Pilot and Feasibility Studies, 2(1), 1-12. https://doi.org/10.1186/s40814-016-0072-0

• Journal Article Type: Article
• Acceptance Date: Jun 25, 2016
• Online Publication Date: Aug 10, 2016
• Publication Date: Aug 10, 2016
• Deposit Date: Nov 23, 2016
• Publicly Available Date: Nov 23, 2016
• Journal: Pilot and Feasibility Studies
• Electronic ISSN: 2055-5784
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 2
• Issue: 1
• Article Number: 45
• Pages: 1-12
• DOI: https://doi.org/10.1186/s40814-016-0072-0
• Keywords: Stroke; Depression; Post-stroke depression; Psychological intervention; Behavioural activation; Feasibility; Randomised controlled trial; Complex intervention
• Public URL: https://nottingham-repository.worktribe.com/output/806066
• Publisher URL: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-016-0072-0
• Contract Date: Nov 23, 2016