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

Journal article

Thomas, SA, Coates, E, Nair, RD, Lincoln, N, Cooper, C, Palmer, R, Walters, SJ, Latimer, NR, England, TJ, Mandefield, L, Chater, T, Callaghan, P and Drummond, AER (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), pp. 45/1-45/12. https://doi.org/10.1186/s40814-016-0072-0
AuthorsThomas, SA, Coates, E, Nair, RD, Lincoln, N, Cooper, C, Palmer, R, Walters, SJ, Latimer, NR, England, TJ, Mandefield, L, Chater, T, Callaghan, P and Drummond, AER
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.

KeywordsStroke; Behavioural activation; Complex intervention; Depression; Post-stroke depression; Psychological intervention; Randomised controlled trial; Feasibility
Year2016
JournalPilot and Feasibility Studies
Journal citation2 (1), pp. 45/1-45/12
PublisherBioMed Central
Digital Object Identifier (DOI)https://doi.org/10.1186/s40814-016-0072-0
Publication dates
Print10 Aug 2016
Publication process dates
Deposited14 Feb 2018
Accepted25 Jun 2016
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