- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04458870
Acceptance and Commitment Therapy for Family Caregivers of People With Dementia
December 8, 2020 updated by: Areum Han, University of Alabama at Birmingham
Internet-based Acceptance and Commitment Therapy for Family Caregivers of People With Dementia
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Acceptance and Commitment Therapy
|
Participants will receive 10 weekly individual acceptance and commitment therapy by a trained coach through zoom video-conferencing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from baseline to 10 weeks
|
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.
|
Change from baseline to 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Zarit Burden Interview
Time Frame: 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.
|
Change from baseline to 10 weeks
|
Brief Coping Orientation to Problems Experienced
Time Frame: 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.
|
Change from baseline to 10 weeks
|
Engagement in Meaningful Activities Survey
Time Frame: 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.
|
Change from baseline to 10 weeks
|
Experiential Avoidance in Caregiving Questionnaire
Time Frame: 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.
|
Change from baseline to 10 weeks
|
Acceptance and Action Questionnaire-II
Time Frame: 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.
|
Change from baseline to 10 weeks
|
Cognitive Fusion Questionnaire
Time Frame: 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.
|
Change from baseline to 10 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cortisol levels by collecting fingernails
Time Frame: Change from baseline to 10 weeks
|
A biological measure of stress will be assessed through analysis of cortisol levels in caregivers' nail samples.
|
Change from baseline to 10 weeks
|
System Usability Scale
Time Frame: 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.
|
at 10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 2020
Primary Completion (ACTUAL)
November 9, 2020
Study Completion (ACTUAL)
November 9, 2020
Study Registration Dates
First Submitted
June 26, 2020
First Submitted That Met QC Criteria
July 2, 2020
First Posted (ACTUAL)
July 7, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 10, 2020
Last Update Submitted That Met QC Criteria
December 8, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300005230
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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