Title: Behavioural Activation Therapy for Depression after Stroke (BEADS): A feasibility randomised controlled pilot trial of a psychological intervention for post-stroke depression
Funder: Department of Health (England)

Abstract: Design: Parallel group feasibility randomised controlled trial Setting: Three community stroke services. Intervention provided in participants’ own homes.Inclusion criteria: Stroke >18 years old community dwelling between 3 months to 5 years post stroke depressed (identified by scoring 10 or more on Patient Health Questionnaire-9 (PHQ-9) [5] for those able to complete it or more than 50 on Visual Analog Mood Scales (VAMS) Sad [6] for those who unable to complete PHQ-9 due to aphasia).Exclusions: Blind deaf unable to speak English documented dementia had received medical or psychological treatment for depression at the time at which they had their stroke.Interventions: Participants randomly allocated to1) Usual stroke care. Receive all other services routinely available as local practice. 2) Behavioural activation therapy (BAT). In addition to usual care participants receive up to 15 one hour sessions of BAT from an assistant psychologist (two sites) or IAPT therapist (one site) over 4 months. Delivery tailored to individual needs and communication style. We will document whether participants receive antidepressant medication are referred to or receive IAPT or other psychological services. Patients currently receiving antidepressants will be included so we can assess appropriateness of including them in the full trial. Carer involvement in the intervention will be recorded.Feasibility outcomes: 1.Feasibility of recruitment to a definitive trial (primary outcome) based on on proportion meeting study criteria proportion consenting and consent rate. 2.Participant carer and therapist views on acceptability of procedures and intervention3.Number of missing/incomplete data on baseline and outcome measures4.Number of participants needing assistance with completing study assessments5.Attrition at outcome6.Potential value of conducting main trial using value of information analysis7.Description of usual care 8.Treatment fidelity of BATClinical outcomes at 6 months:1.Patient Health Questionnaire-9* (measure of depression severity for those able to complete) - primary outcome2.VAMS Sad*3.Stroke Aphasic Depression Questionnaire* (observer-rated depression) [7]4.Nottingham Leisure Questionnaire* (leisure activities) [8] 5.Nottingham Extended Activities of Daily Living (functional outcome) [9]6.Carer Strain Index [10]7.EuroQol EQ-5D* (health related quality of life)–standard version [11] and version for people with cognitive problems [12] 8.Health-care resource use questionnaire* *Baseline measure in addition to Modified Rankin Scale [13] Frenchay Aphasia Screening Test [14] and Montreal Cognitive Assessment [15].Sample size: Based on need to estimate uncertain critical parameters (SD for continuous outcomes; consent rate attrition) to inform the RCT a sample size of 60 patients allows SD to be estimated to within precision of approximately ±19% of its true value (95% confidence). 72 participants to be recruited to allow for 15% attrition.Analysis: Consent recruitment and follow-up rate by centre and randomized group. Outcome measures summarised overall and by group. Estimate of intra-cluster correlation. Estimate of effect size for PHQ-9 (with confidence interval) to check the likely effect is within clinically relevant range. Feedback interviews analysed using Thematic Analysis [16]. Outcome from economic evaluation will be provided by value of information analysis [17].


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: STROKE;MENTAL HEALTH