Abstract
BACKGROUND: Depression affects almost 60% of stroke survivors, impacting on recovery and quality-of-life. Depression may be treated with medication or talk-based therapies. One randomised controlled trial showed a talk-based therapy called motivational interviewing-based intervention (MIBI) delivered early after stroke reduced depressive symptoms at 3 and 12 months post-stroke compared with receiving usual care alone. However, it was unclear if the benefit was due to the specific MIBI components or simply the additional attention received. This trial aims to determine the effect of MIBI plus usual care on reducing depressive symptoms post-stroke, relative to usual care (UC), and to an attention control (AC) (social attention without therapeutic content, i.e. general conversation). METHODS: Patients admitted following acute stroke meeting the study eligibility criteria (not currently receiving talk-based therapy and not currently having severe depression) will be recruited across 18 UK hospitals within 28 days of stroke. A total of 1287 participants will be randomised on a 1:1:1 ratio into three groups: MIBI + UC; AC + UC; UC. Participants in MIBI + UC and AC + UC will additionally have remote (telephone/online) sessions with MIBI therapists or AC providers respectively, for four 45-min weekly sessions, beginning within 6 weeks of randomisation. Participant self-report measures of depression (primary outcome, Patient Health Questionnaire (PHQ-9) at 3 months) and quality-of-life will be collected at baseline, 6 weeks and 3 months post-randomisation. The proposed mechanism of effect, via participants' self-efficacy and confidence, and the impact of MIBI dose and/or therapeutic alliance on outcome will also be explored. If benefit of MIBI + UC over UC is demonstrated, mixed effects regression will be fitted to outcome data from all three arms, and appropriate parametrisation with MIBI + UC as the reference group. A mixed-methods process evaluation comprising quantitative assessment of intervention adherence and fidelity and semi-structured interviews with a purposive sample of study participants (n ~ 18) and MIBI/AC staff (n ~ 15) will explore participation, acceptability, and considerations for implementation. An economic evaluation will explore cost-effectiveness. DISCUSSION: The results will inform whether any observed improvements in mood are a natural change over time, due to attention, or a therapeutic change attributable to MIBI. If MIBI is shown to effectively reduce depressive symptoms, the process evaluation will inform implementation of the intervention into clinical care. TRIAL REGISTRATION: ISRCTN, ISRCTN17065351. Registered 01/02/2022, https://www.isrctn.com/ISRCTN17065351 .