The BEADS Feasibility Pilot Trial
Research type
Research Study
Full title
Behavioural Activation Therapy for Depression after Stroke (BEADS): A feasibility randomised controlled pilot trial of a psychological intervention for post-stroke depression
IRAS ID
165632
Contact name
Angela Shone
Contact email
Sponsor organisation
University of Nottingham
ISRCTN Number
ISRCTN12715175
Duration of Study in the UK
2 years, 7 months, 30 days
Research summary
One-third of people become depressed after stroke. It is important that depression is treated as it can have negative effects on recovery, quality of life and carer strain. Currently there is insufficient evidence to tell us which psychological intervention is effective and affordable.
Our study aims to find out whether it is feasible to conduct a study to evaluate a psychological treatment, called behavioural activation (BA) therapy, for treating post–stroke depression. BA aims to improve mood by increasing the time people spend doing activities they enjoy.
The proposed study is a pilot randomised controlled trial. People can take part if they had their stroke between 3 months and 5 years ago and have post-stroke depression. 72 participants in 3 centres will be recruited from hospital wards, using hospital and community databases, referrals from community clinicians and voluntary stroke groups. Participants will be divided into two groups at random. Half of the people will receive up to 15 sessions of BA over 4 months; the other half will not receive BA but will receive care as usual. No participants will have existing treatments withdrawn. Six months after joining the study participants will be visited by a Researcher, who will complete questionnaires to assess the participant’s mood, activity level, quality of life, and to record other healthcare they have received. The impact on carers' health, quality of life and life of support provided will also be measured. We will interview eight participants and five carers from each group to ask their views on the research process and intervention. Therapists delivering the intervention in each site will also be interviewed. The results of the study will tell us whether it is feasible and affordable to conduct a full-scale trial evaluating BA for treating post-stroke depression, and will inform us how to design it.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
15/EM/0014
Date of REC Opinion
29 Jan 2015
REC opinion
Further Information Favourable Opinion