Sleep as a Mechanism of Change in Alcohol Use

NCT ID: NCT06286774

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-02
• Study Completion Date: 2028-05-30

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, 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CBT-I

Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Intervention Type: BEHAVIORAL

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.

Waitlist control

Control participants will receive CBT-I at the end of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT-I

Eligibility Criteria

Inclusion Criteria

• report heavy drinking in a typical week in the past month
• meet DSM-5 criteria for Alcohol Use Disorder
• meet DSM-5 and research diagnostic criteria for Insomnia Disorder

Exclusion Criteria

• ≥50 years
• unable to provide informed consent
• report contraindications for CBT-I (mania or seizure disorder)
• moderate to severe sleep apnea that is untreated
• have symptoms requiring immediate clinical attention (e.g., psychosis, suicide plan)
• are already receiving behavioral treatment for insomnia or alcohol use

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Mary E Miller

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Missouri-Columbia

Columbia, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mary Beth Miller Miller, PhD

Role: CONTACT

millmary@health.missouri.edu

573-882-1813

Rebecca Patterson, BSc

Role: CONTACT

rap5z6@umsystem.edu

573-882-8598

Facility Contacts

Mary Beth Miller, PhD

Role: primary

millmary@health.missouri.edu

573-882-1813

Rebecca Patterson, BSc

Role: backup

rap5z6@umsystem.edu

573-882-8598

Other Identifiers

2096884

Identifier Type: -

Identifier Source: org_study_id