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Sleep as a Mechanism of Change in Alcohol Use — ReTRAIN  

Insomnia Clinical Trial

Official title:
Sleep as a Mechanism of Change in Alcohol Use Outcomes Among Heavy-Drinking Adults

Clinical Trial Summary

This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.

Clinical Trial 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, n=112) or waitlist control (WLC, n=112). 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. Primary outcomes include insomnia severity, drinking quantity, and alcohol-related consequences. Data will be analyzed using multilevel models. The results of the proposed research will inform research and clinical practice by determining the extent to which sleep operates as a mechanism of alcohol behavior change. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06286774
Study type Interventional
Source University of Missouri-Columbia
Contact Mary Beth Miller Miller, PhD
Phone 573-882-1813
Email millmary@health.missouri.edu
Status Not yet recruiting
Phase N/A
Start date March 1, 2024
Completion date April 1, 2028
View Details
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