Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors

NCT06758505 | Recruiting

• 2 other identifiers: STUDY24030133R03HD114635
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Stroke; Chronic Phase of Disease

Keywords

Strategy Training; Acceptance and Commitment Therapy; Social Participation

Outcome Measures

Primary Outcomes (2)

• Feasibility: Fidelity (for each group)

  Fidelity is measured using Strategy Training (ST) and Acceptance and Commitment Therapy (ACT) fidelity tools. All intervention sessions will be video recorded and a random 20 percent will be rated by independent evaluators trained by the principal investigator. ST fidelity will be assessed with the 10-item fidelity tool with 8 or more items rated as adequate or excellent indicating adequate fidelity. ACES fidelity will be assessed with a 22-item tool generated from the 10-item ST and 12-item ACT fidelity tools, with 18 or more items rated as adequate or excellent indicating adequate fidelity. The a priori criterion for adequate fidelity was that equal or greater than 80 percent of intervention sessions are rated with equal or greater than 80 percent of adequate fidelity for each START and ACES intervention.

  Baseline to Post-intervention up to 8 weeks

• Feasibility: Satisfaction (for each group)

  Client satisfaction is measured using the Client Satisfaction Questionnaire. The Clients Satisfaction Questionnaire is an 8-item assessment of satisfaction with the intervention program, rated on a 4-point scale that ranges from 1 to 4 in each item. An average score will be computed for each participant. High scores indicate high satisfaction. The a priori criterion for satisfaction was equal or greater than 80 percent of the sample has mean Client Satisfaction Questionnaire score of equal or greater than 2.5.

  Baseline to Post-intervention up to 8 weeks

Secondary Outcomes (4)

• Changes in social participation: Difficulty to participate in social activities

  Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks

• Changes in social participation: Satisfaction with social participation

  Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks

• Changes in psychological flexibility

  Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks

• Changes in wellbeing

  Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks

Study Arms (2)

ACES

EXPERIMENTAL

Behavioral: Strategy Training embedded with Acceptance and Commitment Therapy Principles

START

ACTIVE COMPARATOR

Behavioral: Strategy Training Only

Interventions

Strategy Training Only BEHAVIORAL

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.

Also known as: START

START

Strategy Training embedded with Acceptance and Commitment Therapy Principles BEHAVIORAL

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.

Also known as: ACES

ACES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

N-(2-acetamido)-2-aminoethanesulfonic acid

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Minmei Shih, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minmei Shih, PhD

CONTACT

412-383-4551; mis235@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 3, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)