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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 is a NA study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 34 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03493958
The ClinicalTrials.gov registry entry for NCT03493958 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sleep Healthy Using the Internet (SHUTi) is the first listed.
NCT03493958 reports 0 study locations.
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.
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