Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT03493958
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2018-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
RCT of Web-Based Behavioral Sleep Intervention for Individuals With Alcohol Use Disorder
Sponsor:
National Institutes of Health Clinical Center (CC)
Organization:
Study Overview
Official Title:
Pilot RCT of Web-based Behavioral Sleep Intervention for Individuals With Alcohol Use Disorder
Status:
COMPLETED
Status Verified Date:
2022-09-28
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
Alcohol use disorder (AUD) is characterized by problematic drinking that becomes severe. The prevalence of insomnia in individuals with alcohol dependence is estimated to be between 36-91% and after two weeks of alcohol detoxification, as many as 65% of these individuals still experience "sleep problems." Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious non-pharmacological treatment for insomnia and is recommended as a first-line treatment for adults with chronic insomnia disorder. CBT-I has been associated with more rapid and "durable" improvement in sleep outcomes, even when compared with other nonpharmacological treatments. Internet-based CBT-I (ICBT-I or eCBT-I for "electronic") could play a key role in the dissemination of this behavioral sleep intervention, given the paucity of trained clinicians able to provide CBT-I in person and other logistical/cost concerns. SHUTi (Sleep Healthy Using The Internet) is the most tested and empirically-sound internet intervention for insomnia. The SHUTi program tailors specific recommendations based on participant responses to sleep diaries and other input within the program. Despite the promise of internet-based CBT-I interventions, very little is known about their effectiveness among individuals with AUD: to date, no RCTs exist examining the feasibility/effectiveness of an internet-based CBT-I program among individuals recovering from AUD. This is a two-phase randomized controlled trial assessing feasibility/acceptability and effectiveness of the SHUTi program for research participants at the NIH Clinical Center. Phase I will be focused on assessing feasibility and effectiveness of program delivery and data collection (n=10). Phase II will be a pilot RCT powered to examine intervention effectiveness (n=20 per group). All participants enrolled in this study will first be admitted under the screening and assessment protocol on the 1SE clinic (14-AA-0181), which includes adults over 18 years of age seeking treatment for alcohol rehabilitation. Participants for this study must also meet criteria for "mild to severe" insomnia. Individuals randomized to the intervention group will receive six sessions of the SHUTi intervention (one completed while inpatient, the rest while outpatient) and individuals randomized to the control group will receive an educational web-based program. The goals of the study are as follows: 1) assess the feasibility and acceptability of Internet-based CBT-I among individuals with AUD in recovery with insomnia (Phase I ), 2) compare the efficacy of CBT-I versus control group with respect to primary and secondary outcome variables (Phase II), and 3) explore specific domains associated with improved outcomes: e.g. demographic, psychiatric, and/or drinking-related factors (Phase II). Primary outcome measures include changes in insomnia severity over time and changes in actigraphy-recorded sleep efficiency over time.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 18-CC-0079 | None | None | View |