Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Strategy Training Only, Strategy Training embedded with Acceptance and Commitment Therapy Principles.
- Who it may be relevant to
- Registry conditions: Stroke, Chronic Phase of Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Detailed description
In April 2025, the investigator 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.
In June 2025, the investigator received notice of award from NIH and thus updated information to be consistent with the IRB protocol.
Interventions
- Behavioral Strategy 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., - Behavioral Strategy 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 fro
Primary outcome measures
- Feasibility: Fidelity (for each group) [Time frame: Baseline to Post-intervention up to 8 weeks]
- Feasibility: Satisfaction (for each group) [Time frame: Baseline to Post-intervention up to 8 weeks]
Secondary outcome measures (4)
- Changes in social participation: Difficulty to participate in social activities [Time frame: Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks]
- Changes in social participation: Satisfaction with social participation [Time frame: Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks]
- Changes in psychological flexibility [Time frame: Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks]
- Changes in wellbeing [Time frame: Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Pittsburgh — Pittsburgh
Identifiers
NCT: NCT06758505 · STUDY24030133 · R03HD114635