Restoring social participation after chronic stroke with strategy training plus acceptance and commitment therapy

Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors

This program will test whether adding acceptance and commitment therapy to strategy training helps adults living with chronic stroke reconnect with social activities.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Pittsburgh (Academic / other)
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT06758505 on ClinicalTrials.gov

What this trial studies

This randomized, home-based intervention assigns community-dwelling adults at least six months after stroke to 10 sessions of either standard strategy training (START) or strategy training embedded with Acceptance and Commitment Therapy principles (ACES). Social participation and psychological flexibility are measured at baseline, immediately after the intervention, and one month later to compare changes between groups. The primary aim is to see if ACES produces clinically meaningful improvements (Cohen's d ≥ 0.2) in social participation compared with START. Key exclusions include progressive neurological disease, severe aphasia, active stroke rehabilitation or untreated major depression, and bipolar or psychotic disorders.

Who should consider this trial

Good fit: Adults (≥18 years) living in the community at least six months after a stroke who report reduced social participation (Activity Card Sort <80% of pre-stroke activities) and can give informed consent are ideal candidates.

Not a fit: People with progressive neurological disorders, severe aphasia that prevents participation, those currently in active stroke rehabilitation or with untreated major depression, or those with bipolar/psychotic disorders may not benefit or be eligible.

Why it matters

Potential benefit: If successful, the combined ACES approach could help people with chronic stroke increase social participation and reduce psychological barriers to community life.

How similar studies have performed: Strategy training has prior evidence for improving activity engagement after stroke and ACT has improved psychological flexibility in other populations, but combining them to improve social participation after chronic stroke is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. primary diagnosis of chronic stroke, ≥6 months post onset,
2. ≥18 years old,
3. community-dwelling (i.e., living in a residential setting in the community),
4. restrictions in social participation, indicated by Activity Card Sort (\<80% of pre-stroke activities)

Exclusion Criteria:

1. progressive neurological diagnosis (e.g., dementia, Parkinson's disease, multiple sclerosis, or brain tumor) reported by participants or proxy,
2. inability to provide written informed consent,
3. severe aphasia (score 0 or 1 on the Boston Diagnostic Aphasia Examination 3rd Edition Severity Rating Scale),
4. currently undergoing stroke rehabilitation or mental health intervention (but participation in maintenance sessions, self-help groups, or couples therapy is permitted),
5. major depressive disorder, indicated by PRIME-MD, unless undergoing treatment for at least 4 weeks and are released to participate by their physician or counselor
6. bipolar or psychotic disorder, indicated by PRIME-MD, or
7. substance use disorder within 3 months, indicated by Mini-International Neuropsychiatric Interview

Where this trial is running

Pittsburgh, Pennsylvania

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Minmei Shih, PhD — University of Pittsburgh
• Study coordinator: Minmei Shih, PhD

Conditions Stroke; Chronic Phase of Disease; Strategy Training; Acceptance and Commitment Therapy; Social Participation