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临床试验/NCT07528261
NCT07528261招募中不适用

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

The Wright Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Multidimensional Psychological Flexibility Inventory - Short Form (MPFI-24)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

研究组 & 干预措施

Experimental Group

Experimental

The group that will receive group-based ACT intervention

干预措施: Group-based ACT Intervention (Behavioral)

Control Group

No Intervention

The group that will not receive group-based ACT intervention

结局指标

主要结局

Multidimensional Psychological Flexibility Inventory - Short Form (MPFI-24)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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").

次要结局

未报告次要终点

研究者

发起方
The Wright Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

John Chi-Wai Yiu

PsyD Candidate

The Wright Institute

研究点 (1)

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