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NCT04632628 · ClinicalTrials.gov registry record · NA
Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers
A NA study of Dementia and Insomnia Chronic, sponsored by University of South Florida.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04632628: Recruiting NA study of Dementia and Insomnia Chronic, sponsored by University of South Florida.
NCT04632628 is a NA study of Dementia and Insomnia Chronic that is actively recruiting participants, run by University of South Florida. The registered enrollment target is 60 participants, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04632628, a NA study of Dementia and Insomnia Chronic, is actively recruiting participants, sponsored by University of South Florida.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Over the next 30 years, more than 10 million persons living with dementia in the United States will receive care at home from an unpaid and untrained family caregiver. At home care is preferred by caregivers and persons with dementia alike, but increases the caregiver's risk of insomnia and related negative health outcomes, including depression, anxiety, cognitive disturbances and poor quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is a highly effective and established evidence based treatment for adults of all ages. Although relatively understudied in dementia caregivers, the research by our group and others suggests CBT-I is also efficacious in caregivers. Our team developed a brief (4 session) CBT-I protocol specifically adapted for dementia caregivers (CBT-I) and has shown in person and remote (i.e. telehealth) delivery of this protocol significantly reduces insomnia symptoms and improves mood (moderate to large effects). Given demands on caregivers' time and limited availability of trained CBT-I providers, a web-based version of CBT-I (WebCBT-I; the online treatment will be called NiteCAPP) is needed to increase the accessibility of this efficacious treatment. WebCBT-I will allow for flexible at home scheduling, and the skills needed to monitor caregiver treatment progress can be quickly and efficiently taught to healthcare providers. The overarching goal of this project is to develop and test WebCBT-I in caregivers of persons with dementia. Objectives 1. To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in dementia caregivers with insomnia. 2. To examine changes in the primary clinical outcomes, including complaints of poor sleep, and fatigue. 3. To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health. 4. To examine the mechanistic variables, including arousal (heart rate var
Primary Outcome
Subjective sleep onset latency (time to fall asleep)
Conditions Studied
Interventions
- BEHAVIORAL Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)
Study Locations (1)
Missouri
- University of Missouri - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-11-14 |
| Est. Completion | 2027-03-31 |
| Phase | NA |
What NCT04632628 shows while recruiting
NCT04632628 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 7,723-participant average among 199 other Dementia trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Dementia appearing as the primary indexed condition, and to 1 intervention - of which Web-based Cognitive Behavior Therapy for Insomnia (CBT-I) is the first listed.
NCT04632628 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04632628 about?
NCT04632628 is a clinical study titled "Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers". Over the next 30 years, more than 10 million persons living with dementia in the United States will receive care at home from an unpaid and untrained family caregiver. At home care is preferred by caregivers and persons with dementia alike, but increases the caregiver's risk of insomnia and related ...
What is the current status of trial NCT04632628?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2023-11-14. Estimated completion is 2027-03-31.
What conditions does trial NCT04632628 study?
This clinical trial studies the following conditions: Dementia, Insomnia Chronic.
What interventions are being tested in trial NCT04632628?
The interventions under investigation include: Web-based Cognitive Behavior Therapy for Insomnia (CBT-I) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04632628?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04632628 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dementia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04632628's enrollment target sits among peer trials
60 142nd of 199 higher than 48 of 199 other Dementia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dementia 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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