Clinical trial NCT06758505: Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors
Official title: Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Chronic Phase of Disease
Keywords: Strategy Training
Acceptance and Commitment Therapy
Social Participation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test a new rehabilitation program, combining acceptance and commitment therapy with strategy training (ST+ACT) to help people resume social participation after stroke and live in the community.

Investigators will also compare the changes in social participation and psychological flexibility from baseline to follow-up at one-month after rehabilitation to see if participants who receive ST+ACT report clinically meaningful improvements (Cohen's d=0.2 or greater) compared to ST alone.

Participants will:

* complete testing to see if they are eligible for the study. If qualified, complete testing to understand how the stroke has affected their daily life
* be randomized to receive either ST+ACT or ST alone rehabilitation program for 10 sessions at their home
* repeat part of the tests at the end of the intervention and one month after

Detailed description: In April 2025, the investigators changed the recruitment status because the first enrolled participant ended up being ineligible. The investigators also updated eligibility criteria and outcome measures to be consistent with the IRB protocol.

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 abuse within 3 months, indicated by Mini-International Neuropsychiatric Interview

Primary outcomes:
measure: Feasibility: Fidelity (for each group)
timeFrame: Baseline to Post-intervention up to 8 weeks
measure: Feasibility: Satisfaction (for each group)
timeFrame: Baseline to Post-intervention up to 8 weeks
Secondary outcomes:
measure: Changes in social participation: Difficulty to participate in social activities
timeFrame: Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks
measure: Changes in social participation: Satisfaction with social participation
timeFrame: Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks
measure: Changes in psychological flexibility
timeFrame: Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks
measure: Changes in wellbeing
timeFrame: Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Minmei Shih, PhD
role: PRINCIPAL_INVESTIGATOR
References: