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

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

doi:10.1186/s40814-016-0072-0

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 Feasibility Stud. 2016 Aug 10:2:45. doi: 10.1186/s40814-016-0072-0. eCollection 2016.

Affiliations

¹ Division of Rehabilitation and Ageing, School of Medicine, B Floor Medical School, Queens Medical Centre, University of Nottingham, Nottingham, NG7 2UH UK.
² Sheffield Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA UK.
³ School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA UK.
⁴ Vascular Medicine, Division of Medical Sciences and GEM, School of Medicine, Royal Derby Hospital, University of Nottingham, Uttoxeter Road, Derby, DE22 3DT UK.
⁵ School of Health Sciences, A Floor, South Block, Queens Medical Centre, University of Nottingham, Nottingham, NG7 2HA UK.

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.

Trial registration: Current controlled trials ISRCTN12715175.

Keywords: Behavioural activation; Complex intervention; Depression; Feasibility; Post-stroke depression; Psychological intervention; Randomised controlled trial; Stroke.

Grants and funding

HTA/13/14/01/DH_/Department of Health/United Kingdom