NCT07528261

Brief 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. 1.Does group-based ACT intervention improve the levels of psychological distress and QoL in family caregivers of stroke survivors?
  2. 2.Do the levels of psychological flexibility and experiential avoidance in family caregivers of stroke survivors mediate the outcome of the ACT Group?
  3. 3.Receive a 5-weekly, 1.5-hour group intervention based on the ACT Model;
  4. 4.Complete study measures at pre-treatment, immediate post-treatment, and 2-month follow-up.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
23mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Sep 2025May 2028

Study Start

First participant enrolled

September 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

April 7, 2026

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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".

    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").

    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").

    Pre-treatment, immediate post-treatment, and 2-month follow-up

Study Arms (2)

Experimental Group

EXPERIMENTAL

The group that will receive group-based ACT intervention

Behavioral: Group-based ACT Intervention

Control Group

NO INTERVENTION

The group that will not receive group-based ACT intervention

Interventions

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

Experimental Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Wright Institute

Alameda, California, 94501-7888, United States

RECRUITING

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Central Study Contacts

Chi Wai Yiu, PsyD Candidate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PsyD Candidate

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 14, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

May 31, 2028

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Against the ethics code to share specific participant data.

Locations