StrokeSTART2ACTNCT06758505
Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors
A study testing Strategy Training Only and Strategy Training embedded with Acceptance and Commitment Therapy Principles in people with Stroke and Chronic Phase of Disease, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Chronic Phase of Disease
- What is being tested?
- Strategy Training Only and Strategy Training embedded with Acceptance and Commitment Therapy Principles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
Minmei Shih, PhD, 412-383-4551, mis235@pitt.edu
About this study
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).
Read more
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
Read the 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.
- Conditions
- Stroke, Chronic Phase of Disease
- Being tested
- Strategy Training Only, Strategy Training embedded with Acceptance and Commitment Therapy Principles
- Keywords
- Strategy Training, Acceptance and Commitment Therapy, Social Participation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategy Training OnlyBehavioural
Also called START
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 PrinciplesBehavioural
Also called ACES
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.
| Study group | Role | What they receive |
|---|---|---|
| ACES | Experimental | Not described Receives: Behavioral: Strategy Training embedded with Acceptance and Commitment Therapy Principles |
| START | Active comparator | Not described Receives: Behavioral: Strategy Training Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Post-intervention up to 8 weeks
Secondary outcomes (4)
Changes in social participation: Difficulty to participate in social activities
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).
Measured: Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks
Changes in social participation: Satisfaction with social participation
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).
Measured: Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks
Changes in psychological flexibility
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).
Measured: Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks
Changes in wellbeing
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).
Measured: Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start29 Sep 2025
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Minmei Shih, University of Pittsburgh
- Investigators
- Minmei Shih, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758505
- Sponsor's protocol ID
- STUDY24030133
- Other IDs
- R03HD114635
- Acronym
- START2ACT
- Status last verified
- Sep 2026
- First submitted
- 18 Dec 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors
- ClinicalTrials.gov ID
- NCT06758505
- Acronym / sponsor ID
- START2ACT / STUDY24030133
- Conditions
- Stroke, Chronic Phase of Disease
- Keywords
- Strategy Training, Acceptance and Commitment Therapy, Social Participation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACES | Experimental | Behavioral: Strategy Training embedded with Acceptance and Commitment Therapy Principles |
| START | Active comparator | Behavioral: Strategy Training Only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strategy Training OnlyAlso: STARTParticipants 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. | Behavioural | START |
| Strategy Training embedded with Acceptance and Commitment Therapy PrinciplesAlso: ACESParticipants 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. | Behavioural | ACES |
Primary outcome
Feasibility: Fidelity (for each group)
Time frame: Baseline to Post-intervention up to 8 weeks
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.
Feasibility: Satisfaction (for each group)
Time frame: 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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Minmei Shih, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strategy Training Only and Strategy Training embedded with Acceptance and Commitment Therapy Principles in people with Stroke and Chronic Phase of Disease, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minmei Shih, PhD (412-383-4551, mis235@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Fidelity (for each group) (time frame: Baseline to Post-intervention up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.