TY - JOUR
T1 - Behavioural Activation Therapy for Depression after Stroke (BEADS)
T2 - A study protocol for a feasibility randomised controlled pilot trial of a psychological intervention for post-stroke depression
AU - Thomas, Shirley A.
AU - Coates, Elizabeth
AU - das Nair, Roshan
AU - Lincoln, Nadina B.
AU - Cooper, Cindy
AU - Palmer, Rebecca
AU - Walters, Stephen J.
AU - Latimer, Nicholas R.
AU - England, Timothy J.
AU - Mandefield, Laura
AU - Chater, Timothy
AU - Callaghan, Patrick
AU - Drummond, Avril E.R.
N1 - Publisher Copyright:
© 2016 The Author(s).
PY - 2016/8/10
Y1 - 2016/8/10
N2 - 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 4months for patients with post-stroke depression. We aim to recruit 72 patients with post-stroke depression over 12months 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 6months 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.
AB - 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 4months for patients with post-stroke depression. We aim to recruit 72 patients with post-stroke depression over 12months 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 6months 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.
KW - Psychological intervention
KW - Complex intervention
KW - Behavioural activation
KW - Depression
KW - Randomised controlled trial
KW - Stroke
KW - Feasibility
KW - Post-stroke depression
UR - http://www.scopus.com/inward/record.url?scp=85036585473&partnerID=8YFLogxK
U2 - 10.1186/s40814-016-0072-0
DO - 10.1186/s40814-016-0072-0
M3 - Article
SN - 2055-5784
VL - 2
SP - 45/1-45/12
JO - Pilot and Feasibility Studies
JF - Pilot and Feasibility Studies
IS - 1
M1 - 45
ER -