Health TrialsbyHealthPanel

ACT Group for Family Caregivers of Stroke Survivors

ConditionsCaregiver StressCaregiver Stress SyndromeCaregiver BurnoutCaregiver DistressCaregiver ExhaustionCaregiver Health Related QOLCaregiver Burden for Those Who Care for Adults With Impaired Functional StatusCaregiver Quality of LifeCaregiver BurdenCaregiver Mental HealthCaregiver Resilience and StressCaregiver Sense of Control Over LifeCaregiver AwarenessCaregiver Stress in Chronic Mental Illness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorThe Wright Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group-based ACT Intervention

    Behavioral

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

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

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".

Time frame
Pre-treatment, immediate post-treatment, and 2-month follow-up
3

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").

Time frame
Pre-treatment, immediate post-treatment, and 2-month follow-up
4

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").

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Wright Institute

Lead sponsor

Source ClinicalTrials.gov
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