Clinical trial NCT04458870: Acceptance and Commitment Therapy for Family Caregivers of People With Dementia
Official title: Internet-based Acceptance and Commitment Therapy for Family Caregivers of People With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Keywords: Caregivers
Dementia
Alzheimer's Disease
Burden
Quality of life
Acceptance and Commitment Therapy
Mindfulness
Psychological health
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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).

Primary outcomes:
measure: Depression, Anxiety and Stress Scale - 21
timeFrame: Change from baseline to 10 weeks
measure: Care-related Quality of Life instrument
timeFrame: Change from baseline to 10 weeks
Secondary outcomes:
measure: Zarit Burden Interview
timeFrame: Change from baseline to 10 weeks
measure: Brief Coping Orientation to Problems Experienced
timeFrame: Change from baseline to 10 weeks
measure: Engagement in Meaningful Activities Survey
timeFrame: Change from baseline to 10 weeks
measure: Experiential Avoidance in Caregiving Questionnaire
timeFrame: Change from baseline to 10 weeks
measure: Acceptance and Action Questionnaire-II
timeFrame: Change from baseline to 10 weeks
measure: Cognitive Fusion Questionnaire
timeFrame: Change from baseline to 10 weeks
Other outcomes:
measure: Cortisol levels by collecting fingernails
timeFrame: Change from baseline to 10 weeks
measure: System Usability Scale
timeFrame: at 10 weeks
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Areum Han, PhD
role: PRINCIPAL_INVESTIGATOR
References: