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NCT04308499 · ClinicalTrials.gov registry record · NA
Digital Behavioral Therapy for Sleep Problems
A NA study, sponsored by University of California, Los Angeles.
- Terminated
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT04308499: Clinical Trial NA study, sponsored by University of California, Los Angeles.
NCT04308499 is a NA study that was terminated before completion, run by University of California, Los Angeles. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04308499, a NA study, was terminated before completion, sponsored by University of California, Los Angeles.
- TERMINATED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
Insomnia is very common, especially in HIV population (up to 73%), and contributes to the development of other conditions such as depression, dementia, inflammation, obesity, and heart diseases. Cognitive-behavioral therapy for insomnia (CBT-I) is known to improve insomnia. However, it has never been tested in HIV-positive patients. The investigators aim to examine the Internet version of this therapy in HIV-positive patients because the availability of CBT-I is very limited while the cost is high. The investigators will test this internet version, also called digital CBT-I (dCBTI), against sleep hygiene education (SHE), a commonly prescribed set of instructions in clinical practice, in 60 HIV-positive patients with insomnia invited from the Multicenter AIDS Cohort Study (MACS) Los Angeles site. The investigators aim to test if dCBTI or SHE improves insomnia in this patient group. This trial involves a behavioral treatment that can be done from home with minimal side effects and includes neither medications nor invasive interventions. Lastly, this trial will provide important pilot data for a larger trial testing long-term effects of insomnia treatment in HIV-positive patients.
Primary Outcome
Change in insomnia severity assessed by a scale with higher scores indicating worse outcome (range 0-28)
Interventions
- BEHAVIORAL Digital cognitive-behavioral therapy for insomnia (dCBTI)
- BEHAVIORAL Sleep hygiene education (SHE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-03-01 |
| Est. Completion | 2024-02-01 |
| Phase | NA |
Why NCT04308499 stopped before completion
NCT04308499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Digital cognitive-behavioral therapy for insomnia (dCBTI) is the first listed.
NCT04308499 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04308499 about?
NCT04308499 is a clinical study titled "Digital Behavioral Therapy for Sleep Problems". Insomnia is very common, especially in HIV population (up to 73%), and contributes to the development of other conditions such as depression, dementia, inflammation, obesity, and heart diseases. Cognitive-behavioral therapy for insomnia (CBT-I) is known to improve insomnia. However, it has never bee...
What is the current status of trial NCT04308499?
This trial is currently terminated. It is a NA study. The enrollment target is 24 participants. The study started on 2020-03-01. Estimated completion is 2024-02-01.
What interventions are being tested in trial NCT04308499?
The interventions under investigation include: Digital cognitive-behavioral therapy for insomnia (dCBTI) (BEHAVIORAL), Sleep hygiene education (SHE) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04308499?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04308499's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 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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