- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04847986
Guided Eight-week Online Acceptance and Commitment Therapy for Distressed Family Caregivers of People With Dementia
June 27, 2022 updated by: Areum Han, University of Alabama at Birmingham
A Guided Eight-week Online Acceptance and Commitment Therapy (ACT) Intervention for Distressed Family Caregivers of People With Dementia: A Mixed-methods Pilot Study
The pilot randomized controlled trial aims to assess effects of a guided online acceptance and commitment therapy (ACT) intervention on distressed family caregivers of people with dementia (PwD) compared to the control group.
A total of 24 family caregivers of PwD who meet the inclusion criteria will be recruited and randomized to either the intervention or control group.
Exploratory hypotheses are that the ACT group will show decreases in caregivers' psychological distress and burden and improvements in QoL and engagement in meaningful activities at posttest and 1-month follow-up, compared to the control group.
Also, the project will evaluate the feasibility of recruitment, adherence, and retention of caregivers and explore caregivers' experiences in the ACT intervention through semi-structured interviews at posttest.
As part of the pretest, we will also explore caregivers' perceived impacts of COVID-19 on daily lives.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The pilot randomized controlled trial aims to assess effects of a guided online acceptance and commitment therapy (ACT) intervention on distressed family caregivers of people with dementia (PwD) compared to the control group.
A total of 24 family caregivers of PwD who meet the inclusion criteria will be recruited and randomized to either the intervention or control group.
Caregivers assigned to the intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 8 weeks through Zoom videoconferencing with supplemental psychoeducation materials provided.
Caregivers assigned to the control group will receive care as usual with psychoeducation materials provided.
Outcomes regarding caregivers' mental health will be collected at three time points (i.e., pretest, posttest, and 1-month follow-up) and compared between groups over time.
Exploratory hypotheses are that the ACT group will show decreases in caregivers' psychological distress and burden and improvements in QoL and engagement in meaningful activities at posttest and 1-month follow-up, compared to the control group.
Also, the project will evaluate the feasibility of recruitment, adherence, and retention of caregivers and explore caregivers' experiences in the ACT intervention through semi-structured interviews at posttest.
As part of the pretest, we will also explore caregivers' perceived impacts of COVID-19 on daily lives.
Study Type
Interventional
Enrollment (Actual)
19
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 the primary responsibility for the care of a relative with dementia living in the community
- devoting at least four hours daily to the care of the relative with dementia
- having at least mild symptoms of psychological distress as measured by the Depression, Anxiety and Stress Scale (DASS-21; Antony et al., 1988)
- having a computer or a smartphone with the internet access at home and
- being able to provide informed consent.
Exclusion Criteria:
- having cognitive, physical, or sensory deficits or language barriers (non-English communicator) that impede study participation
- currently receiving a psychological therapy
- having a prior experience in ACT
- having psychiatric hospitalizations or diagnoses of mental illness in the previous two years
- taking antipsychotic or anticonvulsant medication at the time of recruitment
- considering or planning to place family members of PwD in a nursing home within four months or
- 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: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: acceptance and commitment therapy (ACT) group
8 weekly ACT sessions individually guided by a trained coach through Zoom videoconferencing with psychoeducation materials provided
|
Caregivers assigned to this intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 8 weeks through Zoom videoconferencing with psychoeducation materials provided.
|
SHAM_COMPARATOR: Control group
care as usual with psychoeducation materials provided
|
The control group will receive care as usual with psychoeducation materials provided.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline to immediately after the intervention and 1 month follow-up on the Depression, Anxiety and Stress Scale
Time Frame: Change from baseline to immediately after the intervention and 1 month follow-up
|
Depression, Anxiety and Stress Scale - 21 is a 21-item questionnaire assessing depressive symptoms, anxiety, and stress over the past 7 days on a scale of 0 to 3. Scores on the individual subscales range from 0 to 21.
Higher scores indicate greater symptomatology in each subscale of depressive symptoms (7 items), anxiety (7 items), and stress (7 items).
|
Change from baseline to immediately after the intervention and 1 month follow-up
|
Change from baseline to immediately after the intervention and 1 month follow-up on the Zarit Burden Interview
Time Frame: Change from baseline to immediately after the intervention and 1 month follow-up
|
Zarit Burden Interview is a 12-item self-report questionnaire assessing caregiver burden on a scale of 0 to 4. Higher scores indicate higher levels of burden.
The total scores range from 0 to 48, and scores of 17 or greater indicate severe/high burden.
|
Change from baseline to immediately after the intervention and 1 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline to immediately after the intervention and 1 month follow-up on the World Health Organization Quality of Life-BREF - Psychological health component
Time Frame: Change from baseline to immediately after the intervention and 1 month follow-up
|
World Health Organization Quality of Life-BREF - Psychological health component has 6 items measuring psychological quality of life.
Higher scores denote higher quality of life in terms of psychological health.
|
Change from baseline to immediately after the intervention and 1 month follow-up
|
Change from baseline to immediately after the intervention and 1 month follow-up on the Meuser Caregiver Grief Inventory
Time Frame: Change from baseline to immediately after the intervention and 1 month follow-up
|
Marwit-Meuser Caregiver Grief Inventory Brief-Form is a 6-item self-report questionnaire assessing grief of caregivers.
Higher scores indicate higher levels of grief.
|
Change from baseline to immediately after the intervention and 1 month follow-up
|
Change from baseline to immediately after the intervention and 1 month follow-up on the Caregiver Guilt Questionnaire
Time Frame: Change from baseline to immediately after the intervention and 1 month follow-up
|
Caregiver Guilt Questionnaire is a 22-item self-report questionnaire assessing feelings of guilt in caregivers.
Higher scores indicate higher levels of guilt.
|
Change from baseline to immediately after the intervention and 1 month follow-up
|
Change from baseline to immediately after the intervention and 1 month follow-up on the Self-Compassion Scale- Short Form
Time Frame: Change from baseline to immediately after the intervention and 1 month follow-up
|
Self-Compassion Scale- Short Form is a 12-item self-report questionnaire assessing self-compassion.
Higher scores indicate higher levels of self-compassion.
|
Change from baseline to immediately after the intervention and 1 month follow-up
|
Change from baseline to immediately after the intervention and 1 month follow-up on the Action and Acceptance Questionnaire-II
Time Frame: Change from baseline to immediately after the intervention and 1 month follow-up
|
Action and Acceptance Questionnaire -II is a 7-item self-report questionnaire measuring psychological flexibility.
Higher scores indicate poor psychological flexibility.
|
Change from baseline to immediately after the intervention and 1 month follow-up
|
Change from baseline to immediately after the intervention and 1 month follow-up on the Cognitive Fusion Questionnaire
Time Frame: Change from baseline to immediately after the intervention and 1 month follow-up
|
Cognitive Fusion Questionnaire -7 is a 7-item self-report questionnaire measuring cognitive fusion.
Higher scores indicate greater levels of cognitive fusion.
|
Change from baseline to immediately after the intervention and 1 month follow-up
|
Change from baseline to immediately after the intervention and 1 month follow-up on the Engagement in Meaningful Activities Survey
Time Frame: Change from baseline to immediately after the intervention and 1 month follow-up
|
Engagement in Meaningful Activities Survey is a 12-item self-assessment instrument that measures a person's subjective experience of the meaningfulness of everyday activities.
The total scores range from 12 to 48, and higher scores indicate greater levels of engagement in meaningful activities.
|
Change from baseline to immediately after the intervention and 1 month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
System Usability Scale
Time Frame: immediately after the intervention
|
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.
|
immediately after the intervention
|
Interviews of participants
Time Frame: at baseline and immediately after the intervention
|
Caregivers' experiences in the ACT intervention will be explored using individual interviews at posttest.
As part of the pretest assessment, we will also explore perceived impacts of COVID-19 on daily lives of family caregivers of people with dementia through individual interviews.
Each interview will last for about 30 minutes.
|
at baseline and immediately after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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 19, 2021
Primary Completion (ACTUAL)
June 22, 2022
Study Completion (ACTUAL)
June 22, 2022
Study Registration Dates
First Submitted
April 8, 2021
First Submitted That Met QC Criteria
April 12, 2021
First Posted (ACTUAL)
April 19, 2021
Study Record Updates
Last Update Posted (ACTUAL)
June 28, 2022
Last Update Submitted That Met QC Criteria
June 27, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOTFIRG21Han
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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