RecruitingNot ApplicableNCT06758505

Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors


Sponsor

University of Pittsburgh

Enrollment

54 participants

Start Date

Sep 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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 of the intervention and one month after


Eligibility

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria7

  • progressive neurological diagnosis (e.g., dementia, Parkinson's disease, multiple sclerosis, or brain tumor) reported by participants or proxy,
  • inability to provide written informed consent,
  • severe aphasia (score 0 or 1 on the Boston Diagnostic Aphasia Examination 3rd Edition Severity Rating Scale),
  • currently undergoing stroke rehabilitation or mental health intervention (but participation in maintenance sessions, self-help groups, or couples therapy is permitted),
  • 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
  • bipolar or psychotic disorder, indicated by PRIME-MD, or
  • substance use disorder within 3 months, indicated by Mini-International Neuropsychiatric Interview

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALStrategy Training Only

Participants will receive ten 45-60-minute sessions (two times per week) in person in their residence to address real-world performance with an emphasis on START strategy, task-specific practice, and guided discovery to perform social participation activities. In session 1, participants will be guided to select 3 to 5 meaningful social activities and prioritize them. In sessions 2 - 9, participants will use structured START strategy worksheet to try the selected activity; assess execution (e.g., what went well, what did not); reflect on a plan with specific strategies and to address identified challenges; and try social participation activities again. The interventionist will use guided discovery to support START strategy application and to elicit problem solving skills. This process will be repeated iteratively across sessions. In session 10, participants will summarize lessons learned and generate an action plan for after the intervention.

BEHAVIORALStrategy Training embedded with Acceptance and Commitment Therapy Principles

Participants will receive ten 45-60-minute sessions (two times per week) in person in their residence to address real-world performance with task-specific practice and an emphasis on psychological processes using ACT principles. In session 1, participants will clarify value-consistent social participation goals for engaging in 3-5 meaningful activities ("Do What Matters"). In sessions 2-9, participants will be guided applying ACT principles to cope with negative experiences and separate self from thoughts and feelings ("Open Up") and practice mindfulness, stimulate awareness, recognize same person with different experiences, and build self-compassion ("Be Present"). This process (i.e., try an activity that aligns with values and committed actions; assess performance; and reflect on a plan) will be repeated iteratively. In session 10, participants reflect on lessons learned and generate an action plan for after the intervention.


Locations(1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06758505


Related Trials