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Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors

RecruitingNAAges 18 Years - anyAllUniversity of Pittsburgh
NCT06758505 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to test a new rehabilitation program, combining acceptance and commitment therapy with strategy training (ACES), 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 ACES report clinically meaningful improvements (Cohen's d=0.2 or greater) compared to the existing rehabilitation program using strategy training alone (START). 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 ACES or START rehabilitation program for 10 sessions at their home * repeat part of the tests at the end o

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📋 Eligibility rules (as published)
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
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What it tests

  • Strategy Training Only
  • Strategy Training embedded with Acceptance and Commitment Therapy Principles
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Where

1 site
University of Pittsburgh
Pittsburgh, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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