Back to resultsA Ten-Week Online Acceptance and Commitment Therapy Intervention for Family Caregivers of People With Dementia
Primary Purpose
Depressive Symptoms
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and commitment therapy (ACT)
Psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Symptoms focused on measuring Acceptance and Commitment Therapy, Alzheimer's Disease, Burden, Caregivers, Dementia, Mindfulness, Psychological health, Quality of life, Self-compassion, Stress, Depression, Anxiety, Guilt, Grief
Eligibility Criteria
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
- having at least mild depression as measured by the Patient Health Questionnaire (PHQ)-9
- 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
- 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 6 months or
- having the possibility of study dropouts due to medical conditions of caregivers (e.g., surgery that may affect mental health) and their relatives with dementia (e.g., conditions that may impede study participation due to frequent hospitalization or death)
Sites / Locations
- University of Alabama at BirminghamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Acceptance and commitment therapy (ACT) group
Psychoeducation control group
Arm Description
10 weekly ACT sessions individually guided by a trained coach through Zoom videoconferencing with psychoeducation materials provided
Care as usual with psychoeducation materials provided
Outcomes
Primary Outcome Measures
Change from baseline to immediately after the intervention and 3 month follow-up on the Patient Health Questionnaire-9
The Patient Health Questionnaire-9 is a 9-item questionnaire assessing depressive symptoms on a scale of 0 to 3. Scores range from 0 to 27. Higher scores indicate greater symptomatology in depression.
Secondary Outcome Measures
Change from baseline to immediately after the intervention and 3 month follow-up on the Generalized Anxiety Disorder-7
The Generalized Anxiety Disorder-7 is a 7-item questionnaire assessing anxiety on a scale of 0 to 3. Scores range from 0 to 21. Higher scores indicate greater anxiety.
Change from baseline to immediately after the intervention and 3 month follow-up on the Perceived Stress Scale
The Perceived Stress Scale is a 10-item questionnaire assessing stress on a scale of 0 to 4. Scores range from 0 to 40. Higher scores indicate greater stress.
Change from baseline to immediately after the intervention and 3 month follow-up on the World Health Organization Quality of Life - Psychological health component
World Health Organization Quality of Life - Psychological health component has 6 items measuring psychological quality of life on scale of 1 to 5. Scores range from 6 to 30. Higher scores denote higher quality of life in terms of psychological health.
Change from baseline to immediately after the intervention and 3 month follow-up on the Meuser Caregiver Grief Inventory
Marwit-Meuser Caregiver Grief Inventory Brief-Form is a 6-item self-report questionnaire assessing grief of caregivers on a scale of 1 to 5. Scores range from 6 to 30. Higher scores indicate higher levels of grief.
Change from baseline to immediately after the intervention and 3 month follow-up on the Caregiver Guilt Questionnaire
Caregiver Guilt Questionnaire is a 22-item self-report questionnaire assessing feelings of guilt in caregivers on a scale of 0 to 4. Scores range from 0 to 88. Higher scores indicate higher levels of guilt.
Change from baseline to immediately after the intervention and 3 month follow-up on the Self-Compassion Scale- Short Form
Self-Compassion Scale- Short Form is a 12-item self-report questionnaire assessing self-compassion on a scale of 1 to 5. Scores range from 12 to 60. Higher scores indicate higher levels of self-compassion.
Change from baseline to immediately after the intervention and 3 month follow-up on the Action and Acceptance Questionnaire-II
Action and Acceptance Questionnaire -II is a 7-item self-report questionnaire measuring psychological flexibility on a scale of 1 to 7. Scores range from 7 to 49. Higher scores indicate poor psychological flexibility.
Change from baseline to immediately after the intervention and 3 month follow-up on the Cognitive Fusion Questionnaire
Cognitive Fusion Questionnaire -7 is a 7-item self-report questionnaire measuring cognitive fusion on scale of 1 to 7. Scores range from 7 to 49. Higher scores indicate greater levels of cognitive fusion.
Change from baseline to immediately after the intervention and 3-month follow-up on the Engaged Living Scale
Engaged Living Scale -9 is a 9-item self-assessment instrument that measures clarity and engagement with personal values and life fulfillment on a scale of 1 to 5. The total scores range from 9 to 45, and higher scores indicate increased clarity and engagement with personal values and greater life fulfillment.
Change from baseline to immediately after the intervention and 3 month follow-up on the Zarit Burden Interview
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.
Full Information
NCT ID
NCT05043441
First Posted
September 5, 2021
Last Updated
June 14, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Alzheimer's Association
1. Study Identification
Unique Protocol Identification Number
NCT05043441
Brief Title
A Ten-Week Online Acceptance and Commitment Therapy Intervention for Family Caregivers of People With Dementia
Official Title
A Ten-Week Online Acceptance and Commitment Therapy Intervention Guided by a Coach for Family Caregivers of People With Dementia: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Alzheimer's Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This randomized controlled trial aims to assess the effects of a coach-guided ten-week videoconferencing acceptance and commitment therapy (ACT) program on mental health outcomes in depressed family caregivers of people with dementia (PwD) compared to the control group. A total of 64 family caregivers of PwD who meet the eligibility criteria will be recruited and randomized to either the intervention group or the control group. The hypotheses are that the ACT group will show improvements in depressive symptoms, other mental health outcomes, and ACT process measures at posttest and 3-month follow-up, compared to the control group.
Detailed Description
This randomized controlled trial aims to assess the effects of a coach-guided ten-week videoconferencing acceptance and commitment therapy (ACT) program on mental health outcomes in depressed family caregivers of people with dementia (PwD) compared to the control group. A total of 64 family caregivers of PwD who meet the eligibility criteria will be recruited and randomized to either the intervention group or the control group. Caregivers randomly assigned to the intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 10 weeks through Zoom videoconferencing with supplemental psychoeducation materials provided. Caregivers randomly assigned to the control group will receive care as usual with psychoeducation materials provided during the study period. Outcomes regarding caregivers' mental health and ACT processes will be collected at three time points (i.e., pretest, posttest, and 3-month follow-up) and compared between groups over time. The hypotheses are that the ACT group will show improvements in depressive symptoms, other mental health outcomes, and ACT process measures at posttest and 3-month follow-up, compared to the control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
Acceptance and Commitment Therapy, Alzheimer's Disease, Burden, Caregivers, Dementia, Mindfulness, Psychological health, Quality of life, Self-compassion, Stress, Depression, Anxiety, Guilt, Grief
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acceptance and commitment therapy (ACT) group
Arm Type
Experimental
Arm Description
10 weekly ACT sessions individually guided by a trained coach through Zoom videoconferencing with psychoeducation materials provided
Arm Title
Psychoeducation control group
Arm Type
Sham Comparator
Arm Description
Care as usual with psychoeducation materials provided
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and commitment therapy (ACT)
Intervention Description
Caregivers assigned to this intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 10 weeks through Zoom videoconferencing with psychoeducation materials provided.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
The psychoeducation control group will receive care as usual with psychoeducation materials provided.
Primary Outcome Measure Information:
Title
Change from baseline to immediately after the intervention and 3 month follow-up on the Patient Health Questionnaire-9
Description
The Patient Health Questionnaire-9 is a 9-item questionnaire assessing depressive symptoms on a scale of 0 to 3. Scores range from 0 to 27. Higher scores indicate greater symptomatology in depression.
Time Frame
Change from baseline to immediately after the intervention and 3 month follow-up
Secondary Outcome Measure Information:
Title
Change from baseline to immediately after the intervention and 3 month follow-up on the Generalized Anxiety Disorder-7
Description
The Generalized Anxiety Disorder-7 is a 7-item questionnaire assessing anxiety on a scale of 0 to 3. Scores range from 0 to 21. Higher scores indicate greater anxiety.
Time Frame
Change from baseline to immediately after the intervention and 3 month follow-up
Title
Change from baseline to immediately after the intervention and 3 month follow-up on the Perceived Stress Scale
Description
The Perceived Stress Scale is a 10-item questionnaire assessing stress on a scale of 0 to 4. Scores range from 0 to 40. Higher scores indicate greater stress.
Time Frame
Change from baseline to immediately after the intervention and 3 month follow-up
Title
Change from baseline to immediately after the intervention and 3 month follow-up on the World Health Organization Quality of Life - Psychological health component
Description
World Health Organization Quality of Life - Psychological health component has 6 items measuring psychological quality of life on scale of 1 to 5. Scores range from 6 to 30. Higher scores denote higher quality of life in terms of psychological health.
Time Frame
Change from baseline to immediately after the intervention and 3 month follow-up
Title
Change from baseline to immediately after the intervention and 3 month follow-up on the Meuser Caregiver Grief Inventory
Description
Marwit-Meuser Caregiver Grief Inventory Brief-Form is a 6-item self-report questionnaire assessing grief of caregivers on a scale of 1 to 5. Scores range from 6 to 30. Higher scores indicate higher levels of grief.
Time Frame
Change from baseline to immediately after the intervention and 3 month follow-up
Title
Change from baseline to immediately after the intervention and 3 month follow-up on the Caregiver Guilt Questionnaire
Description
Caregiver Guilt Questionnaire is a 22-item self-report questionnaire assessing feelings of guilt in caregivers on a scale of 0 to 4. Scores range from 0 to 88. Higher scores indicate higher levels of guilt.
Time Frame
Change from baseline to immediately after the intervention and 3 month follow-up
Title
Change from baseline to immediately after the intervention and 3 month follow-up on the Self-Compassion Scale- Short Form
Description
Self-Compassion Scale- Short Form is a 12-item self-report questionnaire assessing self-compassion on a scale of 1 to 5. Scores range from 12 to 60. Higher scores indicate higher levels of self-compassion.
Time Frame
Change from baseline to immediately after the intervention and 3 month follow-up
Title
Change from baseline to immediately after the intervention and 3 month follow-up on the Action and Acceptance Questionnaire-II
Description
Action and Acceptance Questionnaire -II is a 7-item self-report questionnaire measuring psychological flexibility on a scale of 1 to 7. Scores range from 7 to 49. Higher scores indicate poor psychological flexibility.
Time Frame
Change from baseline to immediately after the intervention and 3 month follow-up
Title
Change from baseline to immediately after the intervention and 3 month follow-up on the Cognitive Fusion Questionnaire
Description
Cognitive Fusion Questionnaire -7 is a 7-item self-report questionnaire measuring cognitive fusion on scale of 1 to 7. Scores range from 7 to 49. Higher scores indicate greater levels of cognitive fusion.
Time Frame
Change from baseline to immediately after the intervention and 3 month follow-up
Title
Change from baseline to immediately after the intervention and 3-month follow-up on the Engaged Living Scale
Description
Engaged Living Scale -9 is a 9-item self-assessment instrument that measures clarity and engagement with personal values and life fulfillment on a scale of 1 to 5. The total scores range from 9 to 45, and higher scores indicate increased clarity and engagement with personal values and greater life fulfillment.
Time Frame
Change from baseline to immediately after the intervention and 3 month follow-up
Title
Change from baseline to immediately after the intervention and 3 month follow-up on the Zarit Burden Interview
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 3 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
having at least mild depression as measured by the Patient Health Questionnaire (PHQ)-9
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
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 6 months or
having the possibility of study dropouts due to medical conditions of caregivers (e.g., surgery that may affect mental health) and their relatives with dementia (e.g., conditions that may impede study participation due to frequent hospitalization or death)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Areum Han, PhD
Phone
205-975-2882
Email
ahan@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Hawkins
Phone
205-975-2882
Email
jshawkins@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Areum Han, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Areum Han, PhD
Phone
205-975-2882
Email
ahan@uab.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Ten-Week Online Acceptance and Commitment Therapy Intervention for Family Caregivers of People With Dementia
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