ACT Group for Family Caregivers of Stroke Survivors

April 29, 2026 updated by: John Chi-Wai Yiu, The Wright Institute

Effects of Acceptance and Commitment Therapy (ACT) Group for Family Caregivers of Stroke Survivors

The goal of this study is to evaluate the efficacy of group-based ACT intervention in improving the levels of psychological distress in caregivers of stroke survivors. The main questions it aims to answer are:

  1. Does group-based ACT intervention improve the levels of psychological distress and QoL in family caregivers of stroke survivors?
  2. Do the levels of psychological flexibility and experiential avoidance in family caregivers of stroke survivors mediate the outcome of the ACT Group?

The researcher will compare the experimental group (i.e., participants who received group-based ACT intervention) with the control group (i.e., participants who did not receive group-based ACT intervention) to assess whether the group-based ACT intervention is effective in mitigating caregiver stress and improving caregivers' QoL.

Participants in the experimental group will:

  1. Receive a 5-weekly, 1.5-hour group intervention based on the ACT Model;
  2. Complete study measures at pre-treatment, immediate post-treatment, and 2-month follow-up.

Participants in the control group will not receive the group intervention but will complete the same study measures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The proposed study will be the first study performed in the United States to examine the effectiveness of ACT in caregivers of stroke survivors. It aims at evaluating the efficacy of group-based ACT intervention in improving the levels of psychological distress in caregivers of stroke survivors. The author proposes the following hypotheses:

  1. Null hypothesis: Participants assigned to the ACT group will not experience significant improvements in levels of psychological distress and QoL at immediate post-treatment and 2-month follow-up when compared to the control group; Alternative hypothesis: Participants assigned to the ACT group will experience significant improvements in levels of psychological distress and QoL at immediate post-treatment and 2-month follow-up when compared to the control group.
  2. Null hypothesis: The levels of psychological flexibility and experiential avoidance will not mediate the outcome of the ACT Group; Alternative hypothesis: The levels of psychological flexibility and experiential avoidance will mediate the outcome of the ACT Group.

The researcher is interested in exploring whether the ACT group intervention will lead to improvements in psychological outcomes for those participants attending the group, compared to those assigned to the waiting list control group. The proposed study will use a quasi-experimental approach. While in the ideal situation, the researcher would match members in intervention and control groups in pairs with similar demographics or characteristics to minimize the effect of any confounding variables, it is deemed unethical to delay intervention to individuals who have signed up early to the group, as this may be the only source of psychological support available to them. Therefore, the first 20 participants signed up for the ACT Group (i.e., the experimental group) will join the group. In comparison, the latter 20 participants will be placed in the waiting list control group. The participants in the control group will receive the same ACT group intervention after the experimental group completes the intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Chi Wai Yiu, PsyD Candidate
  • Phone Number: 510-974-3626
  • Email: jyiu@wi.edu

Study Locations

  • United States
    • California
      • Alameda, California, United States, 94501-7888
        • Recruiting
        • The Wright Institute
        • Contact:
          • CHI WAI YIU, PsyD Candidate
          • Phone Number: 5109743626
          • Email: jyiu@wi.edu
        • Principal Investigator:
          • CHI WAI YIU, PsyD Candidate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 40 or above.
  • Taking the primary responsibility for the care of a family member suffering from stroke (i.e. spending at least 70% of the time on performing caregiving tasks).
  • The stroke patient has been discharged from hospital and is currently living with the caregiver.
  • Having cared for the stroke patient for at least six months, including at least two months after discharge.
  • CSAQ score (as determied during pre-group screening meeting) indicates a high level of distress, as evidenced by one of the following: a) participant answered "Yes" to either or both questions 4 and 11; b) total "Yes" scores = 10 or more; c) score on question 17 is 6 or higher; d) score on question 18 is 6 or higher.
  • Able to use a computer and has internet access.
  • Able to provide informed consent to participate.

Exclusion Criteria:

  • is below 40 years old.
  • has any comorbid mental disorder or disability that may impede group participation (e.g., personality disorder, learning disability).
  • does not understand English (read, write, listen, and speak).
  • has current active suicidal/homicidal ideation.
  • is currently receiving psychological intervention (individual or group).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
The group that will receive group-based ACT intervention
Behavioral: Group-based ACT Intervention
5-weekly, 1.5-hour group intervention based on the ACT Model
No Intervention: Control Group
The group that will not receive group-based ACT intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Multidimensional Psychological Flexibility Inventory - Short Form (MPFI-24)
Time Frame: Pre-treatment, immediate post-treatment, and 2-month follow-up
The complete version of this questionnaire consists of 60 items that assess the 12 dimensions of psychological flexibility/inflexibility in ACT, including acceptance/experiential avoidance, contact with the present moment/lack of contact with the present moment, self as context/self as content, defusion/fusion, committed action/inaction, and values/lack of contact with values. The short form of the questionnaire consists of the first two items of each subscale such as "I was receptive to observing unpleasant thoughts and feelings without interfering with them" and "I was attentive and aware of my emotions," totaling 24 items.
Pre-treatment, immediate post-treatment, and 2-month follow-up
Adult Carer Quality of Life Questionnaire (AC-QoL)
Time Frame: Pre-treatment, immediate post-treatment, and 2-month follow-up
40-item self-report questionnaire that measures the overall quality of life for adult carers, e.g., "because of caring, I feel that I have grown as a person" and "caring stops me doing what I want to do." The questionnaire consists of eight subscales for different domains of quality of life including support for caring, caring choice, caring stress, money matters, personal growth, sense of value, ability to care, and carer satisfaction. Each item is scored on a 4-point likert scale ranging from "never" to "always".
Pre-treatment, immediate post-treatment, and 2-month follow-up
Experiential Avoidance in Caregiving Questionnaire (EACQ)
Time Frame: Pre-treatment, immediate post-treatment, and 2-month follow-up
15-item self-report scale measuring the three factors of experiential avoidance in the caregiving context, including active avoidant behaviors (caregivers' behaviors aimed at avoiding negative thoughts and feelings related to caregiving) using six items (e.g., "I tend to 'ignore' the negative thoughts that come to me about my relative"), intolerance of negative thoughts and emotions towards the relative (rigid rules about the experience of negative emotions and thoughts related to the care recipient) using four items (e.g., "one should not have bad thoughts about the person you are caring for"), and apprehension concerning negative internal experiences related to caregiving (reluctant and fearful attitudes towards negative private events related to the care recipient) using five items (e.g., "I cannot bear it when I get angry with my relative"). Each item in the questionnaire is rated from 1 ("not at all") to 5 ("a lot").
Pre-treatment, immediate post-treatment, and 2-month follow-up
Modified Caregiver Strain Index (MCSI)
Time Frame: Pre-treatment, immediate post-treatment, and 2-month follow-up
13-item questionnaire that measures the strain of long-term family caregivers, which covers these four domains: financial (e.g., "caregiving is a financial strain"), physical (e.g., "caregiving is a physical strain"), psychological (e.g., "there have been emotional adjustments"), and social and personal (e.g., "there have been changes in personal plans").
Pre-treatment, immediate post-treatment, and 2-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Wright Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WIJYACTSTROKECG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Against the ethics code to share specific participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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