Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors

Not Applicable

Not yet recruiting

• Conditions: Stroke; Chronic Phase of Disease

• Registration Number: NCT06758505
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2025-01-02
• Study First Posted: 2025-01-03
• Status Verified: 2025-05
• Study Start: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2027-05
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility: Fidelity (for each group)	Baseline to Post-intervention up to 8 weeks	Fidelity is measured using ST and 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. ST+ACT 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 ST and ST+ACT intervention.
Feasibility: Satisfaction (for each group)	Baseline to Post-intervention up to 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
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 measured by PROMIS Ability to Participation in Social Roles and Activities.; The PROMIS Ability to Participate in Social Roles and Activities (APS) is a self-report measure that assesses difficulty participation in social roles and activities. APS is an 8-item short form rated on a 5-point scale. High scores indicate high difficulty. The total raw score will be transformed into a t-score that ranges from 0 to 100, with a mean of 50 and a standard deviation of 10.; The a priori criterion for change was a small effect size of change (d=0.2 or greater).
Changes in social participation: Satisfaction with social participation	Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks	Changes in social participation measured by PROMIS Satisfaction with Social Roles and Activities.; The PROMIS Satisfaction with Social Roles and Activities (SPS) is a self-report measure that assesses satisfaction with participation in social roles and activities. SPS is 8-item short form rated on a 5-point scale. High scores indicate low satisfaction. The total raw score will be transformed into a t-score that ranges from 0 to 100, with a mean of 50 and a standard deviation of 10.; The a priori criterion for change was a small effect size of change (d=0.2 or greater).
Changes in psychological flexibility	Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks	Changes in psychological flexibility measured by Multidimensional Psycho-logical Flexibility Inventory.; The Multidimensional Psycho-logical Flexibility Inventory (MPFI) is a self-report measure that assesses psychological flexibility and psychological inflexibility. Each psychological flexibility and inflexibility domain includes 6 scales and each scale has 5 items, rated on a 6-point scale. A total score will be computed for each psychological flexibility and inflexibility domain that ranges from 6 to 180. High scores indicate high levels of measured psychological flexibility and psychological inflexibility.; The a priori criterion for change was a small effect size of change (d=0.2 or greater).
Changes in wellbeing	Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks	Changes in wellbeing measured by Veterans RAND 12-item Health Survey. The Veterans RAND 12-item Health Survey (RAND-12) is a self-report measure that assesses wellbeing ranging from physical to mental health. Items rated on a 5-point scale. Results are summarized as physical component score (PCS) and mental component score (MCS). The raw scores of the PCS and MCS will be transformed into Z-scores that range from 0 to 100, with a mean of 50 and a standard deviation of 10. High scores indicate high levels of wellbeing.; The a priori criterion for change was a small effect size of change (d=0.2 or greater).

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States