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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: 65 Years

Referral Letter Required


Population Exclusion(s)

Non-English Speaking;


Alcohol Dependence;
Alcohol Use Disorder;
Internet CBTI

Recruitment Keyword(s)



Alcohol Use Disorder;
Alcohol Dependence;

Investigational Drug(s)


Investigational Device(s)



Behavioral: Sleep Healthy Using the Internet (SHUTi)

Supporting Site

NIH Clinical CenterUniversity of PennsylvaniaUniversity of Virginia


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.


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


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 hospital.

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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)


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

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Gwenyth R. Wallen, Ph.D.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 6-1484
10 Center Drive
Bethesda, Maryland 20892
(301) 496-0596

Chantal M. Gerrard
National Institutes of Health Clinical Center (CC)
BG 10 RM 4C422
(301) 594-5321

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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