NCT03493958

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

Completed NA Results posted Last updated 23 March 2023

What this trial tests

NA trial testing Sleep Healthy Using the Internet (SHUTi) in Alcohol Use Disorder in 34 participants. Completed in 30 November 2022.

Timeline

5 March 2019

Primary endpoint
14 July 2021

30 November 2022

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	5 March 2019
Primary completion	14 July 2021
Estimated completion	30 November 2022
Sites	1 location across United States

Drugs / interventions tested

• Sleep Healthy Using the Internet (SHUTi)

Conditions studied

• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →
• Alcohol Dependence — all drugs for Alcohol Dependence →
• Insomnia — all drugs for Insomnia →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

Adults 18 to 65, any sex, with Alcohol Use Disorder or Alcohol Dependence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Internet Evaluation and Utility Questionnaire: Average Number of Log in to SHUTi Per Week During the Last 9 Weeks Primary · 9-11 Weeks post SHUTi initiation

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?"

Group	Value	95% CI
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	6	± 1.07

Internet Evaluation and Utility Questionnaire: Average Time Spent on SHUTi After Logging in Primary · 9-11 Weeks post SHUTi initiation

Average amount of time (in minutes) participants spent on SHUTi in the last 9-11 weeks was measured using a survey item, "When you logged in, on average, how much time did you spend on SHUTi?"

Group	Value	95% CI
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	14.9	± 9.83

Internet Evaluation and Utility Questionnaire: Participants With Technical Difficulties Using SHUTi or Tablet Primary · 9-11 Weeks post SHUTi initiation

Participants expressed technical difficulties with SHUTi or study provided tablet using a survey item, "Did you have technical difficulties with SHUTi or your tablet?" with a "yes or no" response

Group	Value	95% CI
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	8
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	3

Internet Evaluation and Utility Questionnaire: Participants Response to "How Comfortable Are You Using the Handheld Tablet?" Primary · 9-11 Weeks post SHUTi initiation

Participants expressed comfort using the tablet with a survey item on a 5-point scale, "How comfortable are you using the handheld tablet?" with '0= not at all' to '4=very'

Group	Value	95% CI
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0

Internet Evaluation and Utility Questionnaire: Participants Response to "How Easy Was SHUTi to Use?" Primary · 9-11 Weeks post SHUTi initiation

Participants ease of using SHUTi was measured with a survey item on a 5-point scale, "How easy was SHUTi to use?" with '0= not at all' to '4=very'

Group	Value	95% CI
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	1

Internet Evaluation and Utility Questionnaire: Participants Response to "How Convenient Was SHUTi to Use?" Primary · 9-11 Weeks post SHUTi initiation

Participants expressed convenience of using SHUTi with a survey item on a 5-point scale, "How convenient was SHUTi to use?" with '0= not at all' to '4=very'

Group	Value	95% CI
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	2
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	1

Internet Evaluation and Utility Questionnaire: Participants Response to "Extent of SHUTi Keeping Their Interest and Attention" Primary · 9-11 Weeks post SHUTi initiation

Participants expressed extent of SHUTi keeping their interest and attention with a survey item on a 5-point scale, "How much did SHUTi keep your interest and attention?" with '0= not at all' to '4=very'

Group	Value	95% CI
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	4
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	6

Internet Evaluation and Utility Questionnaire: Participants Response to "SHUTi Likeability" Primary · 9-11 Weeks post SHUTi initiation

Participants expressed SHUTi likeability with a survey item on a 5-point scale, "How much did you like SHUTi?" with '0= not at all' to '4=very'

Group	Value	95% CI
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	1
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	4
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	2

Internet Evaluation and Utility Questionnaire: Participants Response to "SHUTi Appearance Likeability" Primary · 9-11 Weeks post SHUTi initiation

Participants expressed SHUTi appearance likability with a survey item on a 5-point scale, "How much did you like the way SHUTi looked?" with '0= not at all' to '4=very'

Group	Value	95% CI
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	3

Internet Evaluation and Utility Questionnaire: Participants Response to "SHUTi Privacy Concerns" Primary · 9-11 Weeks post SHUTi initiation

Participants expressed SHUTi privacy concerns with a survey item on a 5-point scale, "How worried were you about your privacy when using SHUTi?" with '0= not at all' to '4=very'

Group	Value	95% CI
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	9
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	1

Internet Evaluation and Utility Questionnaire: Participants Response to "SHUTi Satisfaction" Primary · 9-11 Weeks post SHUTi initiation

Participants expressed satisfaction with SHUTi with a survey item on a 5-point scale, "How satisfied were you with SHUTi?" with '0= not at all' to '4=very'

Group	Value	95% CI
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	2
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	1

Internet Evaluation and Utility Questionnaire: Participants Response to "Usefulness of SHUTi Information" Primary · 9-11 Weeks post SHUTi initiation

Participants expressed usefulness of SHUTi information with a survey item on a 5-point scale, "How useful did you find the information in SHUTi?" with '0= not at all' to '4=very'

Group	Value	95% CI
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	0
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	1
Feasibility and Acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I	1

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.