Acceptance and Commitment Therapy for Family Caregivers of People With Dementia

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT04458870

Collaborator

(none)

Enrollment

Location

Arm

4.3

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Psychological Distress	Behavioral: Acceptance and Commitment Therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Internet-based Acceptance and Commitment Therapy for Family Caregivers of People With Dementia

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Nov 9, 2020

Actual Study Completion Date :

Nov 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acceptance and Commitment Therapy	Behavioral: Acceptance and Commitment Therapy Participants will receive 10 weekly individual acceptance and commitment therapy by a trained coach through zoom video-conferencing.

Arm

Intervention/Treatment

Experimental: Acceptance and Commitment Therapy

Behavioral: Acceptance and Commitment Therapy

Participants will receive 10 weekly individual acceptance and commitment therapy by a trained coach through zoom video-conferencing.

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Other Outcome Measures

Cortisol levels by collecting fingernails [Change from baseline to 10 weeks]
A biological measure of stress will be assessed through analysis of cortisol levels in caregivers' nail samples.
System Usability Scale [at 10 weeks]
The System Usability Scale (SUS) is a 10-item self-report questionnaire measuring usability of a program/intervention. Higher scores indicate greater levels of perceived usability of the intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
devoting at least 1 hour daily to the care of the relative with dementia
having cared for a relative with dementia for at least 3 months
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)
having a computer/smartphone with internet access capable of doing web browsing and video-conferencing
being able to provide informed consent by understanding the nature of study participation.

Exclusion Criteria:

having cognitive, physical, or sensory deficits, or language barriers (non-English communicator) that impede study participation
receiving a psychological therapy currently
having psychiatric hospitalizations or diagnoses of mental illness in the previous 2 years
taking antipsychotic or anticonvulsant medication at the time of recruitment
considering or planning to place family members of dementia in a nursing home within 6 months
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).