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

Status:Enrolling by invitation
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Age Range:18 - 65
Start Date:March 5, 2019
End Date:December 31, 2020

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


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 people s
experiences with a web-based CBT-I program called SHUTi.


To test if a web-based insomnia therapy program works well and helps people with alcohol use


Adults ages 18-65 who joined another protocol and have been an inpatient on that protocol at
least 14 days.


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

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 "moderate 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.


Participants will be eligible for this study if they:

- Are18 - 65 years of age

- Self-report "moderate or severe" insomnia as indicated by a score of 15 or higher on
the Insomnia Severity Index

- Are admitted as an 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)


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 criteria for severe opioid and/or cocaine use disorder in the past year

- Meet criteria for moderate to 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
We found this trial at
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
Bethesda, MD
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