CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
Sleep Healthy Using the Internet (SHUTi)behavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03493958
NCT03493958N/ACompleted

Pilot RCT of Web-based Behavioral Sleep Intervention for Individuals With Alcohol Use Disorder

National Institutes of Health Clinical Center (CC)·interventional·Posted Apr 11, 2018·Updated Mar 23, 2023

In Brief

A clinical study evaluating Sleep Healthy Using the Internet (SHUTi) for Alcohol Use Disorder and 2 related conditions. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 11, 2018
Enrollment StartMar 5, 2019
Primary CompletionJul 14, 2021
Study CompletionNov 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 8.2 years ago

Interventions

Sleep Healthy Using the Internet (SHUTi)behavioral

The SHUTi program is an automated, interactive, internet-based intervention based on well-established face-to-face cognitive behavioral therapy for insomnia (CBT-I) components including sleep restriction, stimulus control, sleep hygiene, cognition