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

doi:10.1186/s40814-016-0072-0

Abstract

BackgroundThere is currently insufficient evidence for the clinical and cost-effectiveness of psychological therapies for treating post-stroke depression.Methods/DesignBEADS 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.DiscussionThe 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 registrationCurrent controlled trials ISRCTN12715175

Highlights

There is currently insufficient evidence for the clinical and cost-effectiveness of psychological therapies for treating post-stroke depression
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
The overarching aim of the Behavioural Activation Therapy for Depression after Stroke (BEADS) trial is to explore the feasibility of a study to investigate the clinical and costeffectiveness of behavioural activation therapy for people with post-stroke depression

Summary

Discussion

This pilot trial is designed to assess the feasibility of a definitive multicentre RCT to evaluate the clinical and costeffectiveness of BA for treating post-stroke depression. Ethical approval was obtained on 29 January 2015. Recruitment to BEADS started in May 2015 and is planned to run until the end of April 2016. Abbreviations BA, behavioural activation; BEADS, Behavioural Activation Therapy for Depression after Stroke; CALM, Communication and Low Mood; CBT, cognitive behavioural therapy; CRF, case report form; CST, Consent Support Tool; CTRU, Clinical Trials Research Unit; DMEC, Data Monitoring and Ethics Committee; IAPT, Improving Access to Psychological Therapies; PHQ-9, Patient Health Questionnaire-9; RCT, randomised controlled trial; TSC, Trial Steering Committee; VAMS, Visual Analog Mood Scales

Background

Objectives

Have a diagnosis of ischaemic or haemorrhagic stroke

Findings