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NCT03493958 · ClinicalTrials.gov registry record · NA
RCT of Web-Based Behavioral Sleep Intervention for Individuals With Alcohol Use Disorder
A NA study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
NCT03493958: Completed NA study, sponsored by National Institutes of Health Clinical Center (CC).
NCT03493958 is a NA study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 34 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
NCT03493958, a NA study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
Study Summary
Background: Many people with alcohol use disorders have a sleep problem called insomnia. One treatment is Cognitive Behavioral Therapy for Insomnia (CBT-I). Researchers want to study adults experiences with a web-based CBT-I program called SHUTi. Objective: To test if a web-based insomnia therapy program works well and helps people with alcohol use disorders. Eligibility: Adults ages 18-65 who joined another protocol and have been an inpatient on that protocol at least 14 days. Design: Participants will be screened with questions about insomnia. They will wear a device on their wrist and finger for one night while sleeping. This checks for sleep apnea. Participants will complete 1 of 2 programs: 1. SHUTi: Participants will start using the program in the hospital and finish it about 6 weeks later. They will get a computer tablet to access SHUTi at least 3 times a week. They will get surveys, stories, videos, and interactive data about sleep. They will complete at least 5 daily sleep diaries every week. SHUTi will be customized based on the diaries. 2. Education-only program: This is like SHUTi but it is not interactive and is not customized. Participants will access it at least once a week. They will finish at their own pace within 6 weeks. These participants may access SHUTi later. All participants will wear a device on their wrist for 4 straight days at several different time points. It records activity and sleep data. They will do this 3 times. Participants will answer questions about the program before starting it and after finishing. Interviews will be audio recorded. Participants will do follow-up surveys 6-7 months after they are discharged from the hospital.
Primary Outcome
Average number of times participants logged into SHUTi 9-11 weeks after SHUTi initiation was measured using a survey item, "On average, how many times did you log in to SHUTi per week during the last 8-9 weeks?"
Interventions
- BEHAVIORAL Sleep Healthy Using the Internet (SHUTi)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-03-05 |
| Est. Completion | 2022-11-30 |
| Phase | NA |
What the finished NCT03493958 record still lists
NCT03493958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 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 1 intervention - of which Sleep Healthy Using the Internet (SHUTi) is the first listed.
NCT03493958 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03493958 about?
NCT03493958 is a clinical study titled "RCT of Web-Based Behavioral Sleep Intervention for Individuals With Alcohol Use Disorder". Background: Many people with alcohol use disorders have a sleep problem called insomnia. One treatment is Cognitive Behavioral Therapy for Insomnia (CBT-I). Researchers want to study adults experiences with a web-based CBT-I program called SHUTi. Objective: To test if a web-based insomnia therapy...
What is the current status of trial NCT03493958?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2019-03-05. Estimated completion is 2022-11-30.
What interventions are being tested in trial NCT03493958?
The interventions under investigation include: Sleep Healthy Using the Internet (SHUTi) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03493958?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03493958's enrollment target sits among peer trials
34 1570th of 2000 higher than 427 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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