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

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.

Conditions

• Alcohol Use Disorder
• Alcohol Dependence
• Insomnia

Interventions

BEHAVIORAL

Sleep Healthy Using the Internet (SHUTi)

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

Sponsors & Collaborators

• University of Pennsylvania

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• National Institutes of Health Clinical Center (CC)

  lead NIH

Principal Investigators

• Gwenyth R Wallen, Ph.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-05

Primary Completion

2021-07-14

Completion

2022-11-30

Countries

• United States

Study Locations