Abstract

Background and aims
Depression affects approximately one-third of stroke survivors and is associated with poorer recovery, increased morbidity and reduced quality of life. Evidence for early psychological interventions post-stroke remains limited. Motivational Interviewing-Based Intervention (MIBI) is a person-centred therapy with promising preliminary evidence. COMMITS evaluated the clinical, and cost-effectiveness of MIBI in reducing depressive symptoms compared with attention control (AC) or usual care (UC).

Methods
COMMITS was a multicentre, three-arm, parallel-group randomised controlled trial conducted across 16 UK stroke units. Adults within 12 weeks post-stroke, able to consent, with PHQ-9≤14 and not receiving psychological therapy were randomised 1:1:1 to MIBI+UC:AC+UC:UC alone. Randomisation used stochastic minimisation over site, age, baseline mood and preferred session format (phone/on-line). MIBI and AC comprised four 45-minute sessions delivered remotely by trained staff. The primary outcome was PHQ-9 score at 3 months post-randomisation. Resource use and EQ-5D-5L were collected for economic evaluation. Outcomes were analysed as intention-to-treat using mixed-effects models with site and therapist as random effects and minimisation factors and baseline value of the outcome measure as fixed effects.

Results
Of 14,047 patients screened, 1,246 were randomised (MIBI+UC n=415; AC+UC n=415; UC n=416). Completion of all 4 sessions was high (MIBI 66.5%; AC 58.1%). Data collection is complete, and primary outcome were available for 65% of participants.

Conclusions
Clinical effectiveness and cost-effectiveness outcomes will be presented. COMMITS will establish whether mood changes reflect natural recovery, non-specific attention effects, or a specific therapeutic benefit of MIBI.

Conflict of interest