CompletedNot Applicable

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

United States34 participantsStarted 2019-03-05

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Internet Evaluation and Utility Questionnaire: Average Number of Log in to SHUTi Per Week During the Last 9 Weeks

Timeframe: 9-11 Weeks post SHUTi initiation

Internet Evaluation and Utility Questionnaire: Average Time Spent on SHUTi After Logging in

Timeframe: 9-11 Weeks post SHUTi initiation

Internet Evaluation and Utility Questionnaire: Participants With Technical Difficulties Using SHUTi or Tablet

Timeframe: 9-11 Weeks post SHUTi initiation

Internet Evaluation and Utility Questionnaire: Participants Response to "How Comfortable Are You Using the Handheld Tablet?"

Timeframe: 9-11 Weeks post SHUTi initiation

Internet Evaluation and Utility Questionnaire: Participants Response to "How Easy Was SHUTi to Use?"

Timeframe: 9-11 Weeks post SHUTi initiation

Internet Evaluation and Utility Questionnaire: Participants Response to "How Convenient Was SHUTi to Use?"

Timeframe: 9-11 Weeks post SHUTi initiation

Trial details

NCT IDNCT03493958

SponsorNational Institutes of Health Clinical Center (CC)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2021-07-14

Results submitted2022-12-29

View on ClinicalTrials.gov More Alcohol Use Disorder trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Internet Evaluation and Utility Questionnaire: Average Number of Log in to SHUTi Per Week During the Last 9 Weeks

Timeframe: 9-11 Weeks post SHUTi initiation

Internet Evaluation and Utility Questionnaire: Average Time Spent on SHUTi After Logging in

Timeframe: 9-11 Weeks post SHUTi initiation

Internet Evaluation and Utility Questionnaire: Participants With Technical Difficulties Using SHUTi or Tablet

Timeframe: 9-11 Weeks post SHUTi initiation

Internet Evaluation and Utility Questionnaire: Participants Response to "How Comfortable Are You Using the Handheld Tablet?"

Timeframe: 9-11 Weeks post SHUTi initiation

Internet Evaluation and Utility Questionnaire: Participants Response to "How Easy Was SHUTi to Use?"

Timeframe: 9-11 Weeks post SHUTi initiation

Internet Evaluation and Utility Questionnaire: Participants Response to "How Convenient Was SHUTi to Use?"

Timeframe: 9-11 Weeks post SHUTi initiation