Strategy Training + Acceptance and Commitment Therapy for Stroke

(START2ACT Trial)

Overseen By Minmei Shih, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Dementia, Parkinson's, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 8 weeks

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new rehab program that combines strategy training with acceptance and commitment therapy to help stroke survivors re-engage in social activities. The researchers aim to determine if this approach improves social participation and psychological flexibility more effectively than strategy training alone. Participants will be randomly assigned to one of these two rehab programs for 10 sessions at home. The trial seeks individuals who experienced a stroke over six months ago and struggle to participate in social activities as before. As an unphased trial, this study offers a unique opportunity to explore innovative rehabilitation methods that could enhance recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have major depressive disorder, you must be undergoing treatment for at least 4 weeks and be released to participate by your physician or counselor.

What prior data suggests that this rehabilitation program is safe for stroke patients?

Research has shown that combining strategy training with acceptance and commitment therapy (ACT) is safe and well-received by stroke survivors. Studies have found that group-based ACT, a component of this combination, helps reduce depression and improve overall health in stroke survivors. This suggests the treatment is generally well-tolerated.

In one study, stroke survivors who participated in ACT found it acceptable and valuable, indicating it fits well into their recovery. Although specific safety data for this combination therapy is limited, ACT has been used safely in many situations, suggesting it is likely safe here too.

This trial does not test a new drug, so the focus is on the delivery and effectiveness of the therapy, rather than concerns about side effects from chemicals. This approach usually carries fewer risks compared to new medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to stroke recovery by combining Strategy Training with principles of Acceptance and Commitment Therapy (ACT). Unlike traditional stroke rehabilitation that primarily focuses on physical recovery, this approach emphasizes psychological flexibility and adaptive strategies to help patients manage the emotional and cognitive challenges post-stroke. By integrating ACT, the treatment aims to improve patients' mental resilience and engagement in their rehabilitation process, potentially leading to more holistic and sustainable recovery outcomes. This innovative combination addresses both the mental and physical aspects of stroke recovery, which could significantly enhance the standard care options currently available.

What evidence suggests that this trial's treatments could be effective for stroke rehabilitation?

Research has shown that acceptance and commitment therapy (ACT) can help stroke survivors. Studies have found that ACT reduces depression and boosts feelings of hope and self-rated health in stroke patients, with these improvements lasting for at least three months after treatment. In this trial, participants in the ACES arm will receive a new program that combines ACT with strategy training to further enhance social participation and mental flexibility for stroke survivors. This innovative approach aims to ease daily life and community involvement after a stroke. Meanwhile, participants in the START arm will receive strategy training only. ^{5 6 7 8 9}

Who Is on the Research Team?

Minmei Shih, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for chronic stroke survivors who want to improve their social participation and live independently in the community. Participants must have had a stroke, be in a stable phase of recovery, and able to complete tests about daily life impacts. They cannot join if they don't meet these criteria.

Inclusion Criteria

Community-dwelling (i.e., living in a residential setting in the community)

I was diagnosed with a stroke more than 6 months ago.

Restrictions in social participation, indicated by Activity Card Sort (<80% of pre-stroke activities)

Exclusion Criteria

Substance abuse within 3 months, indicated by Mini-International Neuropsychiatric Interview

I have been treated for major depression for at least 4 weeks and am cleared by my doctor.

Inability to provide written informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either ST+ACT or ST alone rehabilitation program for 10 sessions at their home

8 weeks

10 sessions (in-person)

Follow-up

Participants are monitored for changes in social participation and psychological flexibility one month after rehabilitation

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Strategy Training embedded with Acceptance and Commitment Therapy Principles
• Strategy Training Only

Trial Overview The study is testing two rehabilitation programs: one with strategy training only (ST) and another combining strategy training with acceptance and commitment therapy principles (ST+ACT). The effectiveness will be measured by improvements in social participation and psychological flexibility after the program.

How Is the Trial Designed?

Group I: ACES Experimental Treatment 1 Intervention

Group II: START Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Acceptance and Commitment Therapy (ACT) may effectively reduce anxiety and depressive symptoms in patients with acquired brain injury (ABI), as shown by medium to large decreases in symptoms for three out of four participants in a year-long study.

Participants also reported improvements in stress and quality of life, although there were no significant changes in psychological flexibility or social participation, indicating that while ACT shows promise, further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy for individuals with depressive and anxiety symptoms following acquired brain injury: A non-concurrent multiple baseline design across four cases. Rauwenhoff, JCC., Bol, Y., Peeters, F., et al.[2023]

A randomized controlled trial involving 140 acute stroke patients demonstrated that group-based acceptance and commitment therapy (ACT) significantly reduced depression levels compared to a control group, with effects lasting up to 3 months after the intervention.

In addition to reducing depression, ACT also improved health-related quality of life, sleep quality, psychological flexibility, cognitive fusion, and confidence in the patients, highlighting its comprehensive benefits for mental health post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of group acceptance and commitment therapy in treating depression for acute stroke patients. Liu, YE., Lv, J., Sun, FZ., et al.[2023]

Acceptance and Commitment Therapy (ACT) shows promising effectiveness in improving functionality and well-being for individuals with psychological disturbances or medical problems, including those with acquired brain injuries (ABI).

There is a growing body of evidence suggesting that ACT and mindfulness-based interventions could be beneficial in the rehabilitation of ABI patients, highlighting the need for further research to rigorously test their efficacy in helping these individuals lead meaningful lives despite their challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it time to act? The potential of acceptance and commitment therapy for psychological problems following acquired brain injury. Kangas, M., McDonald, S.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10726803/

Effectiveness of group acceptance and commitment ... Conclusions. ACT is effective in treating acute stroke patients with depression, and the efficacy was maintained at 3‐month follow‐up.

2. bmjopen.bmj.com bmjopen.bmj.com/content/13/8/e069121

Effectiveness of acceptance and commitment therapy in ... 14 The study found that group-based ACT significantly reduced depression in stroke survivors, and increased self-rated health status and hopefulness.15 Using ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/brb3.3260

Effectiveness of group acceptance and commitment ... ACT is effective in treating acute stroke patients with depression, and the efficacy was maintained at 3-month follow-up.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10441086/

Effectiveness of acceptance and commitment therapy in ... The study found that group-based ACT significantly reduced depression in stroke survivors, and increased self-rated health status and ...

5. researchgate.net researchgate.net/publication/391958249_Acceptance_and_Commitment_Therapy_for_stroke_survivors_in_the_group_setting_A_feasibility_and_pilot_study

(PDF) Acceptance and Commitment Therapy for stroke ... Conclusions: The adjusted group therapy is feasible, while unsufficient treamtent fidelity may be based on downscaled structuring by therapists.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10557283/

Effect of group-based acceptance and commitment therapy on ... The aim of this study is to investigate the effectiveness of group-based ACT on EA, PSD, psychological distress, and quality of life in older stroke survivors ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04984239

Adapting Acceptance and Commitment Therapy for Stroke ... The proposed study is a Stage I successive cohort trial intended to adapt Acceptance and Commitment Therapy (ACT) to meet the specific needs of stroke ...

8. ctv.veeva.com ctv.veeva.com/study/rehabilitation-strategies-for-social-participation-in-chronic-stroke-survivors

Rehabilitation Strategies for Social Participation in Chronic ... The goal of this clinical trial is to test a new rehabilitation program, combining acceptance and commitment therapy with strategy training (ACES), ...

9. tandfonline.com tandfonline.com/doi/full/10.1080/09602011.2025.2469649?af=R

An online, group Acceptance and Commitment Therapy is ... This in-depth qualitative study found that the ACT-informed WAterS intervention was largely acceptable and valued by the stroke survivors who opted to receive ...