Recruiting

ACES vs. START

Sponsor:

University of Pittsburgh

Code:

NCT06758505

Conditions

Stroke

Chronic Phase of Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Strategy Training Only

Strategy Training embedded with Acceptance and Commitment Therapy Principles

Study Details

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

Study ID

NCT06758505

Start date

Sep 29, 2025

Status verified date

Oct, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ACES

active comparator: START

Interventions

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., 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.

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 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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Minmei Shih, PhD

412-383-4551mis235@pitt.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Contacts

Minmei Shih, PhD

412-383-4551mis235@pitt.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Oct 2, 2025

Last verified

Oct, 2025

Keywords

  • Strategy Training
  • Acceptance and Commitment Therapy
  • Social Participation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2025-10-02.