ACT Group for Family Caregivers of Stroke Survivors

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Group-based ACT Intervention
  5-weekly, 1.5-hour group intervention based on the ACT Model

Первичные конечные точки

• Multidimensional Psychological Flexibility Inventory - Short Form (MPFI-24) [Срок оценки: Pre-treatment, immediate post-treatment, and 2-month follow-up]
• Adult Carer Quality of Life Questionnaire (AC-QoL) [Срок оценки: Pre-treatment, immediate post-treatment, and 2-month follow-up]
• Experiential Avoidance in Caregiving Questionnaire (EACQ) [Срок оценки: Pre-treatment, immediate post-treatment, and 2-month follow-up]
• Modified Caregiver Strain Index (MCSI) [Срок оценки: Pre-treatment, immediate post-treatment, and 2-month follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The Wright Institute — Alameda

Идентификаторы

NCT: NCT07528261 · WIJYACTSTROKECG

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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