Caregiver StressNCT07528261
ACT Group for Family Caregivers of Stroke Survivors
A study testing Group-based ACT Intervention in people with Caregiver Stress and Caregiver Stress Syndrome, run by The Wright Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Stress, Caregiver Stress Syndrome, Caregiver Burnout
- What is being tested?
- Group-based ACT Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 31 May 2028
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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
The Wright Institute
Alameda, California, 94501-7888
CHI WAI YIU, PsyD Candidate, 5109743626, jyiu@wi.edu
CHI WAI YIU, PsyD Candidate
About this study
Official title: 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:
- Does group-based ACT intervention improve the levels of psychological distress and QoL in family caregivers of stroke survivors?
- Do the levels of psychological flexibility and experiential avoidance in family caregivers of stroke survivors mediate the outcome of the ACT Group?
Read more
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:
- Receive a 5-weekly, 1.5-hour group intervention based on the ACT Model;
- 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.
Read the 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:
- 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.
- 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.
- Conditions
- Caregiver Stress, Caregiver Stress Syndrome, Caregiver Burnout, Caregiver Distress, Caregiver Exhaustion, Caregiver Health Related QOL
- Being tested
- Group-based ACT Intervention
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based ACT InterventionBehavioural
5-weekly, 1.5-hour group intervention based on the ACT Model
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The group that will receive group-based ACT intervention Receives: Behavioral: Group-based ACT Intervention |
| Control Group | No intervention | The group that will not receive group-based ACT intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional Psychological Flexibility Inventory - Short Form (MPFI-24)
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.
Measured: Pre-treatment, immediate post-treatment, and 2-month follow-up
Adult Carer Quality of Life Questionnaire (AC-QoL)
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".
Measured: Pre-treatment, immediate post-treatment, and 2-month follow-up
Experiential Avoidance in Caregiving Questionnaire (EACQ)
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").
Measured: Pre-treatment, immediate post-treatment, and 2-month follow-up
Modified Caregiver Strain Index (MCSI)
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").
Measured: Pre-treatment, immediate post-treatment, and 2-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver StressStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Wright Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Chi-Wai Yiu, The Wright Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528261
- Sponsor's protocol ID
- WIJYACTSTROKECG
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Against the ethics code to share specific participant data.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acceptance and Commitment Therapy (ACT) Group for Family Caregivers of Stroke Survivors
- ClinicalTrials.gov ID
- NCT07528261
- Acronym / sponsor ID
- WIJYACTSTROKECG
- Conditions
- Caregiver Stress, Caregiver Stress Syndrome, Caregiver Burnout, Caregiver Distress, Caregiver Exhaustion, Caregiver Health Related QOL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Wright InstituteUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 14 Apr 2026 (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 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:
- Does group-based ACT intervention improve the levels of psychological distress and QoL in family caregivers of stroke survivors?
- 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:
- Receive a 5-weekly, 1.5-hour group intervention based on the ACT Model;
- 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.
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Group-based ACT InterventionThe group that will receive group-based ACT intervention |
| Control Group | No intervention | –The group that will not receive group-based ACT intervention |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
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 |
|---|---|---|
| Group-based ACT Intervention5-weekly, 1.5-hour group intervention based on the ACT Model | Behavioural | Experimental Group |
Primary outcome
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.
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".
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").
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").
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 1 May 2026.
- Individual participant dataSharing planned: No. Against the ethics code to share specific participant data.
Related trials for Caregiver Stress
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
Recruiting
Well-being Program for Caregivers of Patients With Advanced Cardiac and Pulmonary Disease
Caregiver, Cardiac Disease
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Active, not recruiting
Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia
Caregiver Burnout
Not yet recruiting
A Mobile Informatics Solution to Assist Caregivers in Care Coordination and Monitoring Social Engagement
Memory Disorders, Mild Cognitive Impairment
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based ACT Intervention in people with Caregiver Stress and Caregiver Stress Syndrome, run by The Wright Institute 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 7 inclusion and 5 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 1 May 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 Chi Wai Yiu, PsyD Candidate (510-974-3626, jyiu@wi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional Psychological Flexibility Inventory - Short Form (MPFI-24) (time frame: Pre-treatment, immediate post-treatment, and 2-month follow-up). The study lists 4 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 1 May 2026.