Acceptance and Commitment Therapy for Family Caregivers of People With Dementia

Not Applicable

Completed

• Conditions: Psychological Distress
• Interventions: Behavioral: Acceptance and Commitment Therapy

• Registration Number: NCT04458870
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The pilot project aims to investigate the feasibility and the preliminary efficacy of a guided online acceptance and commitment therapy (ACT) intervention for distressed family caregivers of people with dementia. A one-group pretest-posttest design (n=15) will be used to investigate the potential effects of the 10 weekly online ACT intervention session on caregivers' outcomes at posttest (10 weeks).

Detailed Description

This project will employ one-group pretest-posttest design to investigate the potential impact of a guided online ACT intervention on improving quality of life and psychological health in distressed family caregivers of people with dementia. After the baseline evaluation, eligible caregivers will receive 10 weekly ACT sessions, individually delivered by a licensed professional counselor online. Each session lasts for one hour. Primary outcome measures will be psychological distress measured by the Depression, Anxiety and Stress Scale (DASS)- 21 and care-related quality of life measured by the Care-related Quality of Life instrument (CarerQol). A one-time interview at the completion of the 10 weekly sessions will be conducted to explore caregivers' experiences in the intervention.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-26
• Study Start: 2020-07-01
• Study First Submitted QC: 2020-07-02
• Study First Posted: 2020-07-07
• Primary Completion: 2020-11-09
• Study Completion: 2020-11-09
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-08
• Last Update Posted: 2020-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. community-dwelling adults (age 18 or over) who are currently taking primary responsibility for the care of a relative with dementia living in the community
2. devoting at least 1 hour daily to the care of the relative with dementia
3. having cared for a relative with dementia for at least 3 months
4. suffering at least mild symptoms of psychological distress measured by the DASS-21 (scores ≥ 5 on Depression Subscale of DASS-21, scores ≥ 4 on Anxiety Subscale, or scores ≥ 8 on Stress Subscale)
5. having a computer/smartphone with internet access capable of doing web browsing and video-conferencing
6. being able to provide informed consent by understanding the nature of study participation.

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Exclusion Criteria

1. having cognitive, physical, or sensory deficits, or language barriers (non-English communicator) that impede study participation
2. receiving a psychological therapy currently
3. having psychiatric hospitalizations or diagnoses of mental illness in the previous 2 years
4. taking antipsychotic or anticonvulsant medication at the time of recruitment
5. considering or planning to place family members of dementia in a nursing home within 6 months
6. having the possibility of study dropouts due to other medical conditions of family members with dementia (e.g., conditions that may impede study participation due to frequent hospitalization or death).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acceptance and Commitment Therapy	Acceptance and Commitment Therapy	-

Primary Outcome Measures

Name	Time	Method
Care-related Quality of Life instrument	Change from baseline to 10 weeks	Care-related Quality of Life instrument (CarerQol) assesses the impact of providing informal care on caregivers and combines a 7-item subjective burden measure (CarerQol-7D) with well-being (CarerQol-VAS). Higher scores indicate higher levels of quality of life.
Depression, Anxiety and Stress Scale - 21	Change from baseline to 10 weeks	The Depression, Anxiety and Stress Scale (DASS)- 21 is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and stress. Higher scores represent greater symptomatology.

Secondary Outcome Measures

Name	Time	Method
Acceptance and Action Questionnaire-II	Change from baseline to 10 weeks	The Action and Acceptance Questionnaire (AAQ)-II is a 7-item self-report questionnaire measuring psychological flexibility. Higher scores indicate poor psychological flexibility.
Engagement in Meaningful Activities Survey	Change from baseline to 10 weeks	The Engagement in Meaningful Activities Survey (EMAS) is a 12-item self-assessment instrument that measures a person's subjective experience of the meaningfulness of everyday activities. Higher scores indicate greater levels of engagement in meaningful activities.
Zarit Burden Interview	Change from baseline to 10 weeks	The Zarit Burden Interview (ZBI) is a 12-item self-report questionnaire assessing caregiver. Higher scores indicate higher levels of burden.
Cognitive Fusion Questionnaire	Change from baseline to 10 weeks	The Cognitive Fusion Questionnaire (CFQ)-7 is a 7-item self-report questionnaire measuring cognitive fusion. Higher scores indicate greater levels of cognitive fusion.
Brief Coping Orientation to Problems Experienced	Change from baseline to 10 weeks	Brief COPE (Coping Orientation to Problems Experienced) is a 28-item self-report questionnaire measuring coping strategies in response to stressors. Three composite subscales include problem-focused, emotion-focused, and dysfunctional coping strategies. Higher scores on a subscale indicates more frequent use of the relevant coping strategies.
Experiential Avoidance in Caregiving Questionnaire	Change from baseline to 10 weeks	The Experiential Avoidance in Caregiving Questionnaire (EACQ) is a 15-item self-report questionnaire measuring experiential avoidance in caregivers. Higher scores indicate greater levels of experiential avoidance.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States