Videoconferencing Acceptance and Commitment Therapy With a Web App Use for Family Caregivers of People With Dementia
Primary Purpose
Depression
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and commitment therapy
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Acceptance and Commitment Therapy, Alzheimer's Disease, Burden, Caregivers, Dementia, Mindfulness, Self-compassion, Stress, Anxiety, Guilt, Grief, Telemedicine
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 web-enabled device (e.g., a smartphone, a tablet, or a laptop/desktop) with the internet access at home
Exclusion Criteria:
- having cognitive, physical, or sensory deficits or language barriers (non-English communicator) that might impede study participation
- receiving a psychological therapy at the time of recruitment
- having a prior experience in acceptance and commitment therapy
- having psychiatric hospitalizations in the previous two years
- considering or planning to place relatives with dementia in a nursing home within 3 months
- recent frequent hospitalizations of their relatives with dementia that might contribute to study dropout
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acceptance and Commitment Therapy
Arm Description
8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy
Outcomes
Primary Outcome Measures
Change from baseline to immediately after the 8-week intervention 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 8-week intervention 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 8-week intervention 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 8-week intervention 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 8-week intervention 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.
Change from baseline to immediately after the 8-week intervention on the Marwit-Meuser Caregiver Grief Inventory Brief-Form
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 8-week intervention 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 8-week intervention 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 8-week intervention 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 8-week intervention 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 8-week intervention 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 8-week intervention on the Five Facet Mindfulness Questionnaire
Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item self-assessment instrument that measures five aspects of mindfulness (i.e., observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience) on a scale of 1 to 5. The total scores range from 39 to 195, and higher scores indicate greater mindfulness.
Full Information
NCT ID
NCT05518968
First Posted
August 25, 2022
Last Updated
July 5, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT05518968
Brief Title
Videoconferencing Acceptance and Commitment Therapy With a Web App Use for Family Caregivers of People With Dementia
Official Title
An Eight-week Program for Family Caregivers of People With Dementia Involving Coach-guided Videoconferencing Sessions With the Use of a Web App Based on Acceptance and Commitment Therapy: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Suspended
Why Stopped
We changed our plan.
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
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
The purpose of the pilot study is to assess the effects of an 8-week program on improving mental health in depressed family caregivers of people with dementia. The program will involve 8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy (ACT) for 8 weeks. Also, the study aims to understand these caregivers' experiences in the program, including their perspectives on the app features and contents. We aim to recruit 8-10 people for this pilot project. Outcomes regarding caregivers' mental health and ACT processes will be collected at pretest and posttest (after the completion of the 8-week program) and compared over time (i.e., posttest scores compared to pretest). At posttest, acceptability and perceived usability of the app will be evaluated using the 10-item System Usability Scale and 30-40 minute individual interviews.
Detailed Description
The purpose of the pilot study is to assess the effects of an 8-week program on improving mental health in depressed family caregivers of people with dementia. The program will involve 8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy (ACT) for 8 weeks. Also, the study aims to understand these caregivers' experiences in the program, including their perspectives on the app features and contents. We aim to recruit 8-10 people for this pilot project. Outcomes regarding caregivers' mental health and ACT processes will be collected at pretest and posttest (after the completion of the 8-week program) and compared over time (i.e., posttest scores compared to pretest). At posttest, acceptability and perceived usability of the app will be evaluated using the 10-item System Usability Scale and 30-40 minute individual interviews. Participants' characteristics will be summarized using descriptive statistics. Either the Wilcoxon signed-rank test (a non-parametric test) or the paired sample t-test (a parametric test) will be performed to test the exploratory hypothesis that participants' scores for the outcome measures would significantly improve at posttest compared to pretest. Because of the exploratory nature of the study, no adjustment of p values will be conducted for multiple statistical comparisons of the outcome measures. Statistical significance will be set at p <.05, and the effect sizes derived from this pilot study will form a basis for determining a sample size with sufficient statistical power required for a subsequent clinical trial. Caregivers' experiences in the app use and perspectives on the developed app will be explored using individual Zoom interviews. Interpretative phenomenological analysis will be used to analyze the interview data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Acceptance and Commitment Therapy, Alzheimer's Disease, Burden, Caregivers, Dementia, Mindfulness, Self-compassion, Stress, Anxiety, Guilt, Grief, Telemedicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acceptance and Commitment Therapy
Arm Type
Experimental
Arm Description
8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and commitment therapy
Intervention Description
8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy
Primary Outcome Measure Information:
Title
Change from baseline to immediately after the 8-week intervention 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 8-week intervention
Secondary Outcome Measure Information:
Title
Change from baseline to immediately after the 8-week intervention 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 8-week intervention
Title
Change from baseline to immediately after the 8-week intervention 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 8-week intervention
Title
Change from baseline to immediately after the 8-week intervention 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 8-week intervention
Title
Change from baseline to immediately after the 8-week intervention 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 8-week intervention
Title
Change from baseline to immediately after the 8-week intervention on the Marwit-Meuser Caregiver Grief Inventory Brief-Form
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 8-week intervention
Title
Change from baseline to immediately after the 8-week intervention 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 8-week intervention
Title
Change from baseline to immediately after the 8-week intervention 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 8-week intervention
Title
Change from baseline to immediately after the 8-week intervention 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 8-week intervention
Title
Change from baseline to immediately after the 8-week intervention 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 8-week intervention
Title
Change from baseline to immediately after the 8-week intervention 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 8-week intervention
Title
Change from baseline to immediately after the 8-week intervention on the Five Facet Mindfulness Questionnaire
Description
Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item self-assessment instrument that measures five aspects of mindfulness (i.e., observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience) on a scale of 1 to 5. The total scores range from 39 to 195, and higher scores indicate greater mindfulness.
Time Frame
Change from baseline to immediately after the 8-week intervention
Other Pre-specified Outcome Measures:
Title
System Usability Scale
Description
The System Usability Scale (SUS) is a 10-item self-report questionnaire measuring usability of a tool/program/intervention. Higher scores indicate greater levels of perceived usability of the intervention.
Time Frame
immediately after the 8-week intervention
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 web-enabled device (e.g., a smartphone, a tablet, or a laptop/desktop) with the internet access at home
Exclusion Criteria:
having cognitive, physical, or sensory deficits or language barriers (non-English communicator) that might impede study participation
receiving a psychological therapy at the time of recruitment
having a prior experience in acceptance and commitment therapy
having psychiatric hospitalizations in the previous two years
considering or planning to place relatives with dementia in a nursing home within 3 months
recent frequent hospitalizations of their relatives with dementia that might contribute to study dropout
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
12. IPD Sharing Statement
Plan to Share IPD
No
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Videoconferencing Acceptance and Commitment Therapy With a Web App Use for Family Caregivers of People With Dementia
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