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Clinical Trials/NCT04458870
NCT04458870
Completed
N/A

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

University of Alabama at Birmingham1 site in 1 country7 target enrollmentJuly 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychological Distress
Sponsor
University of Alabama at Birmingham
Enrollment
7
Locations
1
Primary Endpoint
Care-related Quality of Life instrument
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
November 9, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Areum Han

Assistant Professor

University of Alabama at Birmingham

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Care-related Quality of Life instrument

Time Frame: 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

Time Frame: 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 Outcomes

  • Acceptance and Action Questionnaire-II(Change from baseline to 10 weeks)
  • Engagement in Meaningful Activities Survey(Change from baseline to 10 weeks)
  • Zarit Burden Interview(Change from baseline to 10 weeks)
  • Cognitive Fusion Questionnaire(Change from baseline to 10 weeks)
  • Brief Coping Orientation to Problems Experienced(Change from baseline to 10 weeks)
  • Experiential Avoidance in Caregiving Questionnaire(Change from baseline to 10 weeks)

Study Sites (1)

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