ACT Group for Family Caregivers of Stroke Survivors (NCT07528261) | Clinical Trial Compass
RecruitingNot Applicable
ACT Group for Family Caregivers of Stroke Survivors
United States30 participantsStarted 2025-09-01
Plain-language summary
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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Multidimensional Psychological Flexibility Inventory - Short Form (MPFI-24)
Timeframe: Pre-treatment, immediate post-treatment, and 2-month follow-up
2
Adult Carer Quality of Life Questionnaire (AC-QoL)
Timeframe: Pre-treatment, immediate post-treatment, and 2-month follow-up
3
Experiential Avoidance in Caregiving Questionnaire (EACQ)
Timeframe: Pre-treatment, immediate post-treatment, and 2-month follow-up
4
Modified Caregiver Strain Index (MCSI)
Timeframe: Pre-treatment, immediate post-treatment, and 2-month follow-up