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NCT04338750 · ClinicalTrials.gov registry record · NA
Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Dementia
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT04338750: Completed NA study, sponsored by Indiana University.
NCT04338750 is a NA study that has completed, run by Indiana University. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04338750, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
Caregivers of adults with dementia report higher distress, including anxiety and depressive symptoms, burden, and existential suffering, than caregivers of people with other chronic diseases. Acceptance and Commitment Therapy (ACT) is a behavioral intervention designed to increase psychological flexibility in the face of challenges. Results from our recent proof-of-concept study suggest that ACT is effective in reducing anxiety and associated psychological distress in dementia caregivers. In this study, we will randomize N=60 dementia caregivers in equal numbers to receive either 6 weekly 1-hour telephone-based ACT sessions (TACTICs; experimental) or minimally-enhanced usual care (mEUC; control). We hypothesize that our TACTICs intervention will be feasible and acceptable in this population and will have a greater impact on reducing anxiety and secondary outcomes from baseline to post-intervention, and 3 and 6 months later.
Primary Outcome
Changes in anxiety will be measured using the Generalized Anxiety Disorder Scale (GAD-7), which contains 7 items with total scores ranging from 0 to 21. Scores of 5, 10, and 15 are cut-offs for mild, moderate, and severe anxiety, respectively. An add-on item assessing the patient's global impression of symptom-related impairment helps researchers understand the extent to which anxiety interferes in daily life. The GAD-7 has factorial validity for the diagnosis of general anxiety disorder and is
Interventions
- BEHAVIORAL Telephone Acceptance and Commitment Therapy Intervention for Caregivers
- BEHAVIORAL minimally-Enhanced Usual Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-03-24 |
| Est. Completion | 2021-04-09 |
| Phase | NA |
What the finished NCT04338750 record still lists
NCT04338750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Telephone Acceptance and Commitment Therapy Intervention for Caregivers is the first listed.
NCT04338750 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04338750 about?
NCT04338750 is a clinical study titled "Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Dementia". Caregivers of adults with dementia report higher distress, including anxiety and depressive symptoms, burden, and existential suffering, than caregivers of people with other chronic diseases. Acceptance and Commitment Therapy (ACT) is a behavioral intervention designed to increase psychological flex...
What is the current status of trial NCT04338750?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2020-03-24. Estimated completion is 2021-04-09.
What interventions are being tested in trial NCT04338750?
The interventions under investigation include: Telephone Acceptance and Commitment Therapy Intervention for Caregivers (BEHAVIORAL), minimally-Enhanced Usual Care (BEHAVIORAL).
Who is sponsoring clinical trial NCT04338750?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04338750's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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