COMMITS
(2026)Objective
To determine whether a motivational interviewing-based intervention (MIBI) plus usual care reduces depressive symptoms 3 months after stroke compared with usual care alone and with an attention control plus usual care.
Study Summary
• Trial will randomize 1287 acute stroke patients across 18 UK hospitals in a 1:1:1 ratio to MIBI + UC, AC + UC, or UC alone
• Primary outcome is PHQ-9 depression score at 3 months post-randomisation
• Aims to disentangle whether prior MIBI benefits reflect therapeutic content vs. non-specific attention effects
Intervention
Four 45-min weekly remote (telephone/online) individual sessions of motivational interviewing-based intervention (MIBI) delivered by trained non-specialist clinical staff or Stroke Association Support Coordinators, beginning within 6 weeks of randomisation, in addition to usual care.
Inclusion Criteria
Age ≥18; admitted to a participating UK stroke unit and eligible for consent within 12 weeks of acute stroke onset; able to provide informed consent; no/mild/moderate speech difficulties (COAT score 0–3); PHQ-9 total ≤14 and Q9 = 0 (no active suicidality/severe depression); able to converse in English; access to online video or telephone; willing to adhere to follow-up.
Study Design
Arms: MIBI + Usual Care (n≈429) vs Attention Control + Usual Care (n≈429) vs Usual Care alone (n≈429)
Patients per Arm: 1287 total, 1:1:1 allocation (~429 per arm)
Outcome
• Primary outcome: PHQ-9 depressive symptom score at 3 months post-randomisation
• Secondary aims: mechanism of action (self-efficacy, confidence), moderators (gender, stroke severity, communication problems), dose/therapeutic alliance effects, fidelity, acceptability, cost-effectiveness
Bottom Line
Protocol only — no results yet. COMMITS is designed to determine whether prior benefits of MIBI on post-stroke depression are due to therapeutic content or simply the non-specific attention received, which will inform whether MIBI should be implemented in routine stroke care.
Major Points
- Multi-centre UK RCT protocol; primary outcome PHQ-9 at 3 months post-randomisation
- Three-arm 1:1:1 design (MIBI + UC vs AC + UC vs UC) allows separation of therapeutic effect from non-specific attention
- MIBI delivered remotely (telephone/online) as four 45-min weekly sessions by trained non-specialist clinical staff or Stroke Association Support Coordinators
- Excludes patients with severe depression (PHQ-9 >14 or Q9 >0) or those already receiving talk-based therapy
- Includes mixed-methods process evaluation (fidelity, acceptability, health-inequality considerations) and economic evaluation
- MIBI therapist fidelity assessed with the Motivational Interviewing Treatment Integrity code (MITI); competency threshold = global score 4 and 100% MI-adherent behaviours
- Analysis plan: if MIBI + UC beats UC, mixed-effects regression across all three arms with MIBI + UC as reference to characterise attention contribution
Study Design
- Study Type
- Multi-centre parallel-group randomised controlled superiority trial (study protocol)
- Randomization
- Yes
- Blinding
- Not specified in source text (participant/therapist blinding not feasible given behavioural intervention)
- Sample Size
- 1287
- Follow-up
- 3 months post-randomisation (assessments at baseline, 6 weeks, and 3 months)
- Centers
- 22
- Countries
- United Kingdom
Primary Outcome
Definition: Depressive symptoms measured by the Patient Health Questionnaire (PHQ-9), self-report
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| - |
Limitations & Criticisms
- Study protocol only — no efficacy or safety results available
- Requires English language ability and access to online/telephone technology, potentially limiting generalisability and equity
- Excludes patients with severe depression (PHQ-9 >14 or Q9 >0), limiting applicability to those with more severe post-stroke depression who may need intervention most
- Blinding of participants and therapists to intervention is not feasible for a behavioural talk-based intervention
- 3-month primary endpoint is relatively short; long-term durability of any effect not the primary focus
Citation
Patel et al. Trials (2026) 27:166