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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 is a NA study that has completed, run by Emory University. The registered enrollment target is 44 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04426838
The ClinicalTrials.gov registry entry for NCT04426838 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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