NCT06286774

Sleep as a Mechanism of Change in Alcohol Use

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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, 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.

Conditions

• Insomnia
• Alcohol; Harmful Use

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy for Insomnia	Cognitive Behavioral Therapy for Insomnia (CBT-I). Participants assigned to the CBT-I condition will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.

Timeline

• Start date: 2024-03-02
• Primary completion: 2028-05-30
• Completion: 2028-05-30
• First posted: 2024-02-29
• Last updated: 2025-07-22

Locations

1 site across 1 country: United States