Behavioural Activation therapy for Depression after Stroke (BEADS)
Behavioural Activation therapy for Depression after Stroke (BEADS) is a pilot randomised controlled trial to assess the feasibility of a study to investigate the clinical and cost-effectiveness of behavioural activation (BA) therapy for people with post-stroke depression.
This work builds on the success of a previous study led by the Chief Investigator--CALM (Communication and Low Mood)--which was funded by the Stroke Association to test BA for people with aphasia and showed a positive impact on mood at 6 months.
The study is being led by Shirley Thomas from the Division of Rehabilitation and Ageing at The University of Nottingham and the trial is being coordinated from the Sheffield Clinical Trials Research Unit. The study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (ref: 13/14/01).
Key facts
1. What are you testing?
We are assessing the feasibility of a study to investigate the clinical and cost-effectiveness of behavioural activation (BA) therapy for people with post-stroke depression.
Our key objectives are to assess the feasibility of proceeding to a definitive trial, and the feasibility of delivering BA to people with post-stroke depression.
2. When will the trial take place?
The trial is due to open in May 2015.
3. How many trial participants do you need?
We are aiming to recruit 72 people with post-stroke depression across three centres (Derby, Mansfield and Sheffield) over 12 months. Participants will be randomised to receive BA or usual care for four months.
4. What does the study involve?
The study incorporates qualitative research with participants, carers and therapists and an economic evaluation, and the primary clinical outcome measure is the PHQ-9 (Patient Health Questionnaire 9) at six months after randomisation.
5. How is the study funded?
The study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (ref: 13/14/01).