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NCT04426838 · ClinicalTrials.gov registry record · NA
Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
A NA study, sponsored by Emory University.
- Completed
- Registry status
- NA
- Development phase
- 44
- Enrollment target
NCT04426838: Completed NA study, sponsored by Emory University.
NCT04426838 is a NA study that has completed, run by Emory University. The registered enrollment target is 44 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04426838, a NA study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
Study Summary
Disturbed sleep is stressful to persons living with dementia (PLwD) and their caregivers. It contributes to earlier placement of the PLwD in nursing homes and increase the risk for many psychological and cognitive health issues and poor quality of life for both the PLwD and the caregivers. Given the potential harmful side effects of medications, non-medication alternatives, such as Cognitive Behavioral Therapy for Insomnia (CBTi), may be safer to improve disturbed sleep in this population. CBTi which includes stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring, is effective and has durable and sustained effects on sleep outcomes over the long-term. CBTi has improved sleep disturbances in PLwD and their caregivers, separately. Since disturbed sleep in the PLwD-caregiver dyad is bidirectional and interdependent, targeting the pair as a unit for intervention has the potential to lead to improved sleep and health outcomes for both persons. There is no current published research on CBTi when the PLwD and their caregivers receive the intervention at the same time; as a result, the researchers will examine the 1) feasibility; 2) acceptability; and 3) preliminary efficacy of 4-week CBTi intervention for community-dwelling PLwD and their caregivers who are both experiencing sleep disturbances. Forty PLwD-caregiver dyads will receive CBTi via videoconferencing sessions. Preliminary efficacy of the intervention will be assessed using objective (actigraphy) and subjective sleep quality measures. In addition, semi-structured interviews will be conducted to examine the acceptability and satisfaction with the intervention.
Primary Outcome
Feasibility of the interventions will be assessed with rates of adherence to the study components weekly and over the 4 weeks
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia (CBTi) via Videoconference
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2020-09-30 |
| Est. Completion | 2023-03-10 |
| Phase | NA |
What the finished NCT04426838 record still lists
NCT04426838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Cognitive Behavioral Therapy for Insomnia (CBTi) via Videoconference is the first listed.
NCT04426838 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04426838 about?
NCT04426838 is a clinical study titled "Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad". Disturbed sleep is stressful to persons living with dementia (PLwD) and their caregivers. It contributes to earlier placement of the PLwD in nursing homes and increase the risk for many psychological and cognitive health issues and poor quality of life for both the PLwD and the caregivers. Given the...
What is the current status of trial NCT04426838?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2020-09-30. Estimated completion is 2023-03-10.
What interventions are being tested in trial NCT04426838?
The interventions under investigation include: Cognitive Behavioral Therapy for Insomnia (CBTi) via Videoconference (BEHAVIORAL).
Who is sponsoring clinical trial NCT04426838?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04426838's enrollment target sits among peer trials
44 1423rd of 2000 higher than 566 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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