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NCT Number: NCT07528261

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.

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Key information

Conditions

Caregiver Stress Behavior Behavioral Symptoms Caregiver Awareness Caregiver Burden Caregiver Burden for Those Who Care for Adults With Impaired Functional Status Caregiver Burnout Caregiver Distress Caregiver Exhaustion Caregiver Health Related QOL Caregiver Mental Health Caregiver Quality of Life Caregiver Resilience and Stress Caregiver Sense of Control Over Life Caregiver Stress Syndrome Caregiver Stress in Chronic Mental Illness Stress, Psychological

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Wright Institute

Alameda, California, 94501-7888, United States

Location status: Recruiting

Location contact

CHI WAI YIU, PsyD Candidate

CONTACT

[email protected]

5109743626

CHI WAI YIU, PsyD Candidate

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Group-based ACT Intervention

Behavioral

5-weekly, 1.5-hour group intervention based on the ACT Model

Primary outcomes

  1. 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.

  2. 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".

  3. 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").

  4. 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").

Study contacts

Contact information is provided by the study sponsor or research team.

Chi Wai Yiu, PsyD Candidate

CONTACT

[email protected]

510-974-3626

Sponsors and collaborators

Lead sponsor

The Wright Institute

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 14, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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