54 Participants Needed

Strategy Training + Acceptance and Commitment Therapy for Stroke

MS
Overseen ByMinmei Shih, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pittsburgh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Strategy Training + Acceptance and Commitment Therapy for Stroke?

Research shows that Acceptance and Commitment Therapy (ACT) can improve symptoms and quality of life for people with depression and anxiety, including those who have had a stroke. ACT has been effective in helping individuals with acquired brain injuries to improve their psychological well-being and functionality.12345

Is Strategy Training + Acceptance and Commitment Therapy safe for humans?

The studies reviewed focus on the effectiveness of Acceptance and Commitment Therapy (ACT) for stroke and acquired brain injury patients, but they do not report any specific safety concerns. Generally, ACT is considered safe as it involves psychological techniques to help people manage their thoughts and emotions.12467

How is the Strategy Training + Acceptance and Commitment Therapy treatment for stroke unique?

This treatment is unique because it combines Strategy Training with Acceptance and Commitment Therapy (ACT), which focuses on helping stroke survivors accept their thoughts and feelings and commit to actions that align with their values, potentially improving psychological flexibility and quality of life. Unlike traditional therapies, this approach integrates psychological acceptance and mindfulness principles, which are part of the third wave of behavioral therapies, to address both cognitive and emotional challenges after a stroke.12567

What is the purpose of this trial?

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

Research Team

MS

Minmei Shih, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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)
See 1 more

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
See 4 more

Timeline

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ST+ACTExperimental Treatment1 Intervention
Group II: STActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

Findings from Research

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

References

An evaluation of an open group for depressed mood on a stroke rehabilitation ward: three years of clinical data. [2023]
Brief group-based acceptance and commitment therapy for stroke survivors. [2022]
Conducting Outcomes Research in a Clinical Practice Setting: The Effectiveness and Acceptability of Acceptance and Commitment Therapy (ACT) in a Partial Hospital Program. [2021]
Effectiveness of group acceptance and commitment therapy in treating depression for acute stroke patients. [2023]
Is it time to act? The potential of acceptance and commitment therapy for psychological problems following acquired brain injury. [2021]
Acceptance and commitment therapy for individuals with depressive and anxiety symptoms following acquired brain injury: A non-concurrent multiple baseline design across four cases. [2023]
Measuring psychological flexibility and cognitive defusion in individuals with acquired brain injury. [2021]
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