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

NCT ID: NCT03493958

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-05
• Study Completion Date: 2022-11-30

Brief 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.

Detailed Description

Alcohol use disorder (AUD) is characterized by problematic drinking that becomes severe. The prevalence of insomnia in individuals with alcohol dependence is estimated to be between 36-91% and after two weeks of alcohol detoxification, as many as 65% of these individuals still experience "sleep problems." Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious non-pharmacological treatment for insomnia and is recommended as a first-line treatment for adults with chronic insomnia disorder. CBT-I has been associated with more rapid and "durable" improvement in sleep outcomes, even when compared with other nonpharmacological treatments. Internet-based CBT-I (ICBT-I or eCBT-I for "electronic") could play a key role in the dissemination of this behavioral sleep intervention, given the paucity of trained clinicians able to provide CBT-I in person and other logistical/cost concerns. SHUTi (Sleep Healthy Using The Internet) is the most tested and empirically-sound internet intervention for insomnia. The SHUTi program tailors specific recommendations based on participant responses to sleep diaries and other input within the program. Despite the promise of internet-based CBT-I interventions, very little is known about their effectiveness among individuals with AUD: to date, no RCTs exist examining the feasibility/effectiveness of an internet-based CBT-I program among individuals recovering from AUD. This is a two-phase randomized controlled trial assessing feasibility/acceptability and effectiveness of the SHUTi program for research participants at the NIH Clinical Center. Phase I will be focused on assessing feasibility and effectiveness of program delivery and data collection (n=10). Phase II will be a pilot RCT powered to examine intervention effectiveness (n=20 per group). All participants enrolled in this study will first be admitted under the screening and assessment protocol on the 1SE clinic (14-AA-0181), which includes adults over 18 years of age seeking treatment for alcohol rehabilitation. Participants for this study must also meet criteria for "mild to severe" insomnia. Individuals randomized to the intervention group will receive six sessions of the SHUTi intervention (one completed while inpatient, the rest while outpatient) and individuals randomized to the control group will receive an educational web-based program. The goals of the study are as follows: 1) assess the feasibility and acceptability of Internet-based CBT-I among individuals with AUD in recovery with insomnia (Phase I ), 2) compare the efficacy of CBT-I versus control group with respect to primary and secondary outcome variables (Phase II), and 3) explore specific domains associated with improved outcomes: e.g. demographic, psychiatric, and/or drinking-related factors (Phase II). Primary outcome measures include changes in insomnia severity over time and changes in actigraphy-recorded sleep efficiency over time.

Conditions

Alcohol Use Disorder; Alcohol Dependence; Insomnia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Feasibility and acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I

Individuals with alcohol use disorder (AUD) in recovery with insomnia completed six online classes that include interactive educational content and case studies about insomnia and its precipitating factors. These sessions are designed to parallel traditional (in-person) cognitive behavioral therapy for insomnia (CBT-I) sessions and are tracked and customized. New sessions are available seven days after completion of the previous session. The program includes a variety of interactive features, including goal setting, feedback based on user-identified symptoms, animations, quizzes, vignettes, and video-based expert explanations. Participants have maximum of 9-11 weeks to complete the six sessions.

Group Type: EXPERIMENTAL

Sleep Healthy Using the Internet (SHUTi)

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Participants will be eligible for this study if they:

• Are 18-65 years old
• A score of 10 or higher on the Insomnia Severity Index*
• Are admitted as a treatment-seeking inpatient on 1SE under protocol 14-AA-0181 (signing both the clinical and research consent)
• Have been inpatient for at least 14 days prior to consent/screening
• Can speak, understand, and write in English
• Are able to comply with study requirements (including ability to access the Internet at least 2x per week)

Exclusion Criteria

Participants will be ineligible for this study if they:

• Are pregnant
• Are a prisoner
• Report a physician diagnosis of moderate to severe obstructive sleep apnea (OSA) OR test positive for moderate to severe OSA as documented with an Apnea Hypopnea Index of 15 events/hour based on WatchPAT testing results
• Have irregular sleep schedules that prevent the ability to follow treatment recommendations (i.e. usual bedtimes outside of 8:00 pm to 2:00 am or arising times outside of 4:00 am to 10:00 am)
• Meet SCID-5/DSM-5 criteria for opioid use disorder in the past year
• Meet SCID-5/DSM-5 criteria for severe cocaine use disorder and/or severe cannabis use disorder in the past year
• Meet diagnostic criteria for an unstable or serious psychiatric condition (schizophrenia, bipolar, major depressive disorder not currently in remission) - based on diagnosis from the SCID for DSM-5
• Are participating in any experimental pharmacological intervention study
• Presence of unstable or serious medical/neurologic illness at PI and MAI discretion

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gwenyth R Wallen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Institutes of Health Clinical Center (CC)

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2018-CC-0079.html

NIH Clinical Center Detailed Web Page

Other Identifiers

18-CC-0079

Identifier Type: -

Identifier Source: secondary_id

180079

Identifier Type: -

Identifier Source: org_study_id