Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06286774
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-02-02
Brief Title:
Sleep as a Mechanism of Change in Alcohol Use
Sponsor:
University of Missouri-Columbia
Organization:
University of Missouri-Columbia
Study Overview
Official Title:
Sleep as a Mechanism of Change in Alcohol Use Outcomes Among Heavy-Drinking Adults
Status:
RECRUITING
Status Verified Date:
2024-07
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:
ReTRAIN
Brief Summary:
This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes
Detailed Description:
Heavy alcohol use is prevalent in the United States and results in significant physical and psychological burden One in 10 adults in the United States reports binge drinking on a weekly basis and few are willing to seek mental health treatment Thus additional strategies are needed to engage and treat individuals at risk for alcohol-related harm Half of those who screen positive for hazardous drinking report clinically significant symptoms of insomnia Insomnia tends to be less stigmatized than other mental health disorders and it is one condition for which the field has highly efficacious treatment Thus one potential strategy to engage individuals in mental health treatment and reduce the burden of alcohol use in the United States is to target insomnia This project aims 1 to examine change in insomnia as a mediator of insomnia treatment effects on alcohol use outcomes and sex as a moderator of those effects and 2 to identify mechanisms linking change in insomnia to alcohol use outcomes Adults who drink alcohol and have insomnia will be randomly assigned to Cognitive Behavioral Therapy for Insomnia CBT-I n112 or waitlist control WLC n112 Outcomes will be assessed weekly during treatment at the end of the active intervention period post-treatment and at 1- 3- and 6-month follow-ups
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?:
None