Guided Eight-week Online Acceptance and Commitment Therapy for Distressed Family Caregivers of Pe… (NCT04847986) | Clinical Trial Compass
CompletedNot Applicable
Guided Eight-week Online Acceptance and Commitment Therapy for Distressed Family Caregivers of People With Dementia
United States19 participantsStarted 2021-07-19
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline to immediately after the intervention and 1 month follow-up on the Depression, Anxiety and Stress Scale
Timeframe: Change from baseline to immediately after the intervention and 1 month follow-up
2
Change from baseline to immediately after the intervention and 1 month follow-up on the Zarit Burden Interview
Timeframe: Change from baseline to immediately after the intervention and 1 month follow-up