Behavioural activation for the prevention of poststroke depression in low-income older stroke survivors (LIVE WEL): protocol for a randomised controlled trial.

introductionPoststroke depression (PSD) affects approximately 33% of stroke survivors and is associated with worse outcomes, poor quality of life (QOL) and mortality. Despite its prevalence and consequences, there is no consensus on the most effective strategy for PSD prevention. Behavioural activation (BA) is an effective intervention for depression across diverse populations and is considered safer, better tolerated and a longer-lasting alternative to antidepressant medications. This study aims to test the effectiveness of a remotely delivered BA intervention to prevent PSD (Tele-BA-S). METHODS AND ANALYSIS: We will conduct a randomised effectiveness trial of 350 low-income adults (≥ 55 years) within 3 months of ischaemic or haemorrhagic stroke and with subthreshold depression (Patient Health Questionnaire-9 score <9 and 24-item Hamilton Depression Rating Scale (HDRS) score <15). Eligible and consented adults will be randomly assigned to Tele-BA-S or treatment-as-usual. Tele-BA-S will be comprised of an orientation session, 5 weekly BA sessions and 2 follow-up monthly booster calls delivered by trained community health workers. We will conduct assessments at 1 month, 2 months, 4 months, 6 months and 9 months after baseline. The primary outcome (PSD) will be measured by the 24-item HDRS. Secondary outcomes will include anxiety (Generalised Anxiety Disorder-7 Scale), psychological well-being (Ryff Scale of Psychological Well-being), QOL (Stroke Specific QOL Scale), medication adherence (Medication Adherence Report Scale-5), rehabilitation adherence (Rehabilitation Adherence Inventory), number of emergency department visits and hospitalisations, functional outcome (Barthel Index) and degree of disability (Modified Rankin Scale). Mediating variables will include self-efficacy (Stroke Self-Efficacy Questionnaire), motivation (Motivation in Stroke Patients for Rehabilitation Scale) and activity engagement (Neuro-QOL Participation in Roles and Activities). Exploratory implementation measures will also be collected. Primary analysis will follow the intention-to-treat principle and evaluate intervention effects over time using mixed-effects models. ETHICS AND DISSEMINATION: Ethical approval was obtained by the University of Texas Health Science Center at Houston's (UTHealth Houston) Committee for the Protection of Human Subjects Institutional Review Board. The trial protocol, statistical analysis plan and code, and deidentified participant data will be made available via the National Institute of Mental Health Data Archive. The results will be presented at academic conferences and submitted for publication. The authors declare that they have no conflicts of interest relevant to the content of this manuscript. TRIAL REGISTRATION NUMBER: NCT06864715.