Quality of Life Clinical Trial
Official title:
Brief Online Acceptance Commitment Therapy for Caregivers: A Fully Longitudinal Mixed Methods RC
Verified date | October 2023 |
Source | Utah State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Family caregivers for persons with dementia report high levels of depression, stress, and burden. Caregivers' limited time, transportation constraints, and unpredictable schedules make on-line, self-guided interventions more accessible and scalable. Acceptance and Commitment Therapy (ACT) is an established and effective in-person therapy, well-suited to the dementia care giving context where caregivers cannot minimize stress exposure, and report difficult thoughts and emotions. ACT for Caregivers is an on-line self-guided ACT intervention that showed effectiveness in a Stage I pilot (n=52) with participants reporting decreased depressive symptoms, stressful reactions to caring, and caregiver burden, and increased quality of life and positive aspects of caring (all p <.05). Learning from the pilot, the current Stage III intervention will shorten the program from 10 sessions to 6 sessions. The investigators introduce a wait list randomized control trial (RCT) design with fully longitudinal mixed methods to evaluate ACT for Caregivers. Data will be collected at pretest, post-test, and 6-weeks follow-up. Study aims are: 1) to evaluate ACT for Caregivers in a larger sample using an RCT, 2) to understand user experiences and the process of change by collecting short response data from all participants at all time points and interviewing a subset of participants in-depth at two time points, 3) to integrate quantitative and qualitative findings and examine areas of convergence and divergence. This project offers a promising prevention and intervention program to support family caregivers that is scalable, at low cost and with high impact.
Status | Active, not recruiting |
Enrollment | 121 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Self-identification as a family caregiver to a person with dementia or other significant memory loss 2. Interest in taking part in an on-line self-guided program with multiple assessments up through 6-week follow-up 3. Distressed from the care giving role, as measured by a score of 4+ on a single item "How distressed are you by caring for your family member?" (1 not at all to 10 extremely) 4. Ability to read/write English 5. Access to a computer/smartphone/tablet with Internet 6. Caregiver does not have to live with the care recipient, as distress can arise with or without cohabitation, participants must live within the United States. Exclusion Criteria: 1. Not caring for a family caregiver to a person with dementia or other significant memory loss 2. Not interested in an on-line self-guided program with multiple assessments up through 6-week follow-up 3. Responds with a score of 3 or less when asked "How distressed are you by caring for your family member?" (1 not at all to 10 extremely) 4. Inability to read/write English 5. Does not have reliable access to a computer/smartphone/tablet with Internet. 6. Lives outside of the United States 7. Younger than 18 years old |
Country | Name | City | State |
---|---|---|---|
United States | Utah State University | Logan | Utah |
Lead Sponsor | Collaborator |
---|---|
Utah State University |
United States,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean group (waitlist/treatment) differences in caregiver burden | Group differences between waitlist and treatment group scores after the treatment group has had access to the treatment for 30 days and the waitlist group has not received any intervention for the same amount of time. Caregiver burden is measured by a 12-item [short] caregiver burden scale. Participants rate the impact of caregiving on multiple aspects of health (response range 0 never to 4 nearly always). A total possible summed scores range from 0 to 48; higher scores indicate higher burden. | 30 days | |
Primary | Mean group (waitlist/treatment) differences in depressive symptoms | Group differences between waitlist and treatment group scores after the treatment group has had access to the treatment for 30 days and the waitlist group has not received any intervention for the same amount of time. Depressive symptoms are measured by 10-item [short] Center for Epidemiological Studies Depression Scale (CES-D). Participants rate the frequency of depressive symptoms during the past week. Responses range from 1 rarely or none of the time to 4 all of the time, with possible summed scores ranging from 10 to 40; higher scores indicate more depressive symptoms. | 30 days | |
Primary | Mean group (waitlist/treatment) differences in positive aspects of caregiving | Group differences between waitlist and treatment group scores after the treatment group has had access to the treatment for 30 days and the waitlist group has not received any intervention for the same amount of time. Positive aspects of caregiving will be measured using a 9-item Positive Aspects of Caregiving measure. Items use the following stem "Providing help to (name) has…", with example items such as "made me feel useful" and "enabled me to appreciate life more." Responses range from 1 disagree a lot to 5 agree a lot, and items are summed with a possible score range from 9 to 45; higher scores indicate more positive aspects of caregiving. | 30 days | |
Primary | Mean group (waitlist/treatment) differences in sleep quality | Group differences between waitlist and treatment group scores after the treatment group has had access to the treatment for 30 days and the waitlist group has not received any intervention for the same amount of time. Sleep quality will be measured by a 1-item Sleep Quality Scale ranging from 0 terrible to 10 excellent, with higher scores indicating higher quality. Respondents are asked to consider the overall quality of sleep on most nights over the last seven days only. | 30 days | |
Primary | Mean group (waitlist/treatment) differences in psychological flexibility | Group differences between waitlist and treatment group scores after the treatment group has had access to the treatment for 30 days and the waitlist group has not received any intervention for the same amount of time. Psychological flexibility will be measured by the 23-item CompACT consisting of three subscales: openness to experience (10 items; possible score range 0 to 60), behavioral awareness (5 items; possible score range 0 to 30), and valued actions (8 items; possible score range 0 to 48). Responses range from 0 strongly disagree to 6 strongly agree. Some items are reverse scored. Lower scores indicate more psychological flexibility. | 30 days | |
Primary | Mean group (waitlist/treatment) differences in quality of life | Group differences between waitlist and treatment group scores after the treatment group has had access to the treatment for 30 days and the waitlist group has not received any intervention for the same amount of time. Quality of life will be measured by a 1-item visual analogue scale ranging from 0 to 100, with higher scores indicating higher quality of life. | 30 days | |
Primary | Within person change from Pretest measures at Posttest and Follow up in caregiver burden | Change over time for all participants comparing scores from before the intervention, to after 30 day of access to the treatment, and again 6 weeks after the end of the initial 30 day period. Caregiver burden is measured by a 12-item [short] caregiver burden scale. Participants rate the impact of caregiving on multiple aspects of health (response range 0 never to 4 nearly always). A total possible summed scores range from 0 to 48; higher scores indicate higher burden. | Pretest before intervention, 30 days of treatment access, and 6 weeks after initial 30 day period | |
Primary | Within person change from Pretest measures at Posttest and Follow up in depressive symptoms | Change over time for all participants comparing changes in scores from before the intervention, to after 30 day of access to the treatment, and again 6 weeks after the end of the initial 30 day period. Depressive symptoms are measured by 10-item [short] Center for Epidemiological Studies Depression Scale (CES-D). Participants rate the frequency of depressive symptoms during the past week. Responses range from 1 rarely or none of the time to 4 all of the time, with possible summed scores ranging from 10 to 40; higher scores indicate more depressive symptoms. | Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period | |
Primary | Within person change from Pretest measures at Posttest and Follow up in positive aspects of caregiving | Change over time for all participants comparing changes in scores from before the intervention, to after 30 day of access to the treatment, and again 6 weeks after the end of the initial 30 day period. Positive aspects of caregiving will be measured using a 9-item Positive Aspects of Caregiving measure. Items use the following stem "Providing help to (name) has…", with example items such as "made me feel useful" and "enabled me to appreciate life more." Responses range from 1 disagree a lot to 5 agree a lot, and items are summed with a possible score range from 9 to 45; higher scores indicate more positive aspects of caregiving. | Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period | |
Primary | Within person change from Pretest measures at Posttest and Follow up in sleep quality | Change over time for all participants comparing changes in scores from before the intervention, to after 30 day of access to the treatment, and again 6 weeks after the end of the initial 30 day period. Sleep quality will be measured by a 1-item Sleep Quality Scale ranging from 0 terrible to 10 excellent, with higher scores indicating higher quality. Respondents are asked to consider the overall quality of sleep on most nights over the last seven days only. | Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period | |
Primary | Within person change from Pretest measures at Posttest and Follow up in psychological flexibility | Change over time for all participants comparing changes in scores from before the intervention, to after 30 day of access to the treatment, and again 6 weeks after the end of the initial 30 day period. Psychological flexibility will be measured by the 23-item CompACT consisting of three subscales: openness to experience (10 items; possible score range 0 to 60), behavioral awareness (5 items; possible score range 0 to 30), and valued actions (8 items; possible score range 0 to 48). Responses range from 0 strongly disagree to 6 strongly agree. Some items are reverse scored. Lower scores indicate more psychological flexibility. | Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period | |
Primary | Within person change from Pretest measures at Posttest and Follow up in quality of life | Change over time for all participants comparing changes in scores from before the intervention, to after 30 day of access to the treatment, and again 6 weeks after the end of the initial 30 day period. Quality of life will be measured by a 1-item visual analogue scale ranging from 0 to 100, with higher scores indicating higher quality of life. | Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period | |
Primary | Description of participant experience using this intervention | Qualitative interviews will capture how participant experiences support, refine, and contradict acceptance commitment therapy (ACT) principles. | 30 days | |
Primary | Change from Post intervention experience at Follow up | Qualitative interviews will capture changes in participant's attitudes and enactment of principles learned during the treatment. | 30 days after access to program to 6 weeks later |
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