Protocol Details
Pilot RCT of Web-based Behavioral Sleep Intervention for Individuals with Alcohol Use Disorder
This study is NOT currently recruiting participants.
Summary
Number |
18-CC-0079 |
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 |
Yes |
Population Exclusion(s) |
Non-English Speaking;
Children |
Keywords |
Alcohol Dependence;
Alcohol Use Disorder;
Insomnia;
CBTI;
Internet CBTI |
Recruitment Keyword(s) |
None |
Condition(s) |
Alcohol Use Disorder;
Alcohol Dependence;
Insomnia |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
Behavioral: Sleep Healthy Using the Internet (SHUTi)
|
Supporting Site |
NIH Clinical CenterUniversity of PennsylvaniaUniversity of Virginia |
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.
Eligibility
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
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT03493958