N/A
N=25
RCT of Web-Based Behavioral Sleep Intervention for Individuals With Alcohol Use Disorder
Alcohol Use Disorder · Alcohol Dependence · Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT03493958 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Internet Evaluation and Utility Questionnaire: Average Number of Log in to SHUTi Per Week During the Last 9 Weeks — 6 logins per week
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sleep Healthy Using the Internet (SHUTi) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institutes of Health Clinical Center (CC)
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Internet Evaluation and Utility Questionnaire: Average Number of Log in to SHUTi Per Week During the Last 9 Weeks |
6 | — |
| PRIMARY Internet Evaluation and Utility Questionnaire: Average Time Spent on SHUTi After Logging in |
14.9 | — |
| PRIMARY Internet Evaluation and Utility Questionnaire: Participants With Technical Difficulties Using SHUTi or Tablet |
8; 3 | — |
| PRIMARY Internet Evaluation and Utility Questionnaire: Participants Response to "How Comfortable Are You Using the Handheld Tablet?" |
0; 0; 0; 0; 11 | — |
| PRIMARY Internet Evaluation and Utility Questionnaire: Participants Response to "How Easy Was SHUTi to Use?" |
0; 0; 0; 1; 10 | — |
| PRIMARY Internet Evaluation and Utility Questionnaire: Participants Response to "How Convenient Was SHUTi to Use?" |
0; 0; 2; 1; 8 | — |
| PRIMARY Internet Evaluation and Utility Questionnaire: Participants Response to "Extent of SHUTi Keeping Their Interest and Attention" |
0; 0; 4; 6; 1 | — |
| PRIMARY Internet Evaluation and Utility Questionnaire: Participants Response to "SHUTi Likeability" |
0; 1; 4; 2; 4 | — |
| PRIMARY Internet Evaluation and Utility Questionnaire: Participants Response to "SHUTi Appearance Likeability" |
0; 0; 0; 3; 8 | — |
| PRIMARY Internet Evaluation and Utility Questionnaire: Participants Response to "SHUTi Privacy Concerns" |
9; 0; 0; 1; 1 | — |
| PRIMARY Internet Evaluation and Utility Questionnaire: Participants Response to "SHUTi Satisfaction" |
0; 0; 2; 1; 8 | — |
| PRIMARY Internet Evaluation and Utility Questionnaire: Participants Response to "Usefulness of SHUTi Information" |
0; 0; 1; 1; 9 | — |
| PRIMARY Internet Evaluation and Utility Questionnaire: Participants Response to "Understanding SHUTi Information" |
0; 0; 0; 2; 9 | — |
| PRIMARY Internet Evaluation and Utility Questionnaire: Participants Response to "Trust in SHUTi Information Provided" |
0; 0; 0; 3; 8 | — |
| PRIMARY Internet Evaluation and Utility Questionnaire: Participants Likelihood of Continued SHUTi Use When Sleep Problems Continue or Return |
0; 1; 1; 4; 5 | — |
| PRIMARY Internet Evaluation and Utility Questionnaire: Participants Likelihood of Continued SHUTi Use Due to Technical Difficulties |
0; 1; 3; 3; 4 | — |
| PRIMARY Internet Evaluation and Utility Questionnaire: Participants Response to "Internet as a Delivery Method for Insomnia Intervention" |
0; 0; 2; 1; 7 | — |
| PRIMARY Internet Impact and Effectiveness Questionnaire: Participants Response to "SHUTi Helpfulness" |
0; 0; 1; 3; 7 | — |
| PRIMARY Internet Impact and Effectiveness Questionnaire: Participants Response to "Increase in Insomnia Knowledge" |
1; 0; 1; 3; 5 | — |
| PRIMARY Internet Impact and Effectiveness Questionnaire: Participants Response to "Quality of Life Improvement" |
1; 0; 4; 2; 4 | — |
| PRIMARY Internet Impact and Effectiveness Questionnaire: Participants Response to "Mood Improvement" |
0; 0; 3; 4; 4 | — |
| PRIMARY Internet Impact and Effectiveness Questionnaire: Participants Response to "Physical Activity Improvement" |
3; 0; 5; 0; 3 | — |
| PRIMARY Internet Impact and Effectiveness Questionnaire: Participants Response to "Ability to Manage Insomnia" |
0; 0; 1; 5; 5 | — |
| PRIMARY Internet Impact and Effectiveness Questionnaire: Participants Response to "Improvement in Difficulties Falling Asleep" |
0; 1; 2; 2; 6 | — |
| PRIMARY Internet Impact and Effectiveness Questionnaire: Participants Response to "Improvement in Waking up in the Middle of the Night" |
0; 4; 0; 1; 6 | — |
| PRIMARY Internet Impact and Effectiveness Questionnaire: Participants Response to "Improvement in Difficulties Waking up Too Early" |
2; 0; 3; 4; 2 | — |
| PRIMARY Internet Impact and Effectiveness Questionnaire: Participants Response to "Improvement in Sleep Quality" |
0; 0; 2; 3; 6 | — |
| PRIMARY Internet Impact and Effectiveness Questionnaire: Participants Response to "Improvement in Daytime Functioning" |
0; 2; 2; 3; 4 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "Tablet as a Primary Device Used to Access SHUTi" |
1; 10 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "Working Internet Connection" |
8; 0; 1; 2 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to Connection Problem to SHUTi |
7; 0; 0; 4 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "Slow Internet Connection" |
5; 1; 0; 5 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "Problems With Device" |
6; 2; 0; 3 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "Forgetting to Access SHUTi" |
3; 6; 0; 2 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "Not Wanting to Access SHUTi" |
5; 1; 1; 4 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "Personal Issues Interfering With SHUTi Use" |
4; 3; 1; 3 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "Work Issues Interfering With SHUTi Use" |
5; 1; 1; 4 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "Difficulty Navigating SHUTi" |
8; 0; 0; 3 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "Difficulty Understanding SHUTi Content" |
8; 0; 0; 3 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "SHUTi Not Being Useful" |
8; 0; 0; 3 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to SHUTi Program Being Too 'Wordy' |
8; 0; 0; 3 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to Screen Being Too Hard to Read |
8; 0; 0; 3 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "Too Much to do in SHUTi" |
7; 2; 0; 2 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "Diaries Taking Too Long to Complete" |
8; 0; 1; 2 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "SHUTi Helping With Insomnia" |
3; 5; 1; 2 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "Too Many Sleep Rules" |
6; 2; 0; 3 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "Spouse/Significant Other/Roommate Having Issues With Participant Using SHUTi" |
3; 1; 0; 7 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "Difficulty With Sleep Restriction Instructions" |
4; 4; 1; 2 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Who Responded to "Sleep Efficiency Not Improving" |
6; 1; 0; 4 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "Too Much Homework" |
8; 0; 0; 3 | — |
| PRIMARY Internet Intervention Adherence Questionnaire: Participants Response to "Homework Difficulty" |
7; 0; 0; 4 | — |
| PRIMARY Average Login Counts |
46.36 | — |
| PRIMARY Mean Diary Completion Counts |
65.6 | — |
| PRIMARY Average Number of Sessions Completed |
4.35 | — |
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.
Eligibility Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03493958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.