This study is NOT currently recruiting participants.
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)
Investigational Device(s)
Intervention(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.
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.
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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
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
Principal Investigator
Referral Contact
For more information: