Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors (START2ACT)

University of Pittsburgh

Status: Enrolling

Conditions: Stroke; Chronic Phase of Disease

Treatments: Behavioral: Strategy Training Only; Behavioral: Strategy Training embedded with Acceptance and Commitment Therapy Principles

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06758505

R03HD114635 (U.S. NIH Grant/Contract)

STUDY24030133

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

ACES

Experimental group

Treatment:

Behavioral: Strategy Training embedded with Acceptance and Commitment Therapy Principles

START

Active Comparator group

Treatment:

Behavioral: Strategy Training Only