Sleep as a Mechanism of Change in Alcohol Use

NCT06286774 | Recruiting DMC

• 1 other identifier: 2096884
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insomnia; Alcohol; Harmful Use

Keywords

alcohol; drinking; sleep; insomnia

Outcome Measures

Primary Outcomes (3)

• Insomnia Symptoms

  Assessed using Insomnia Severity Index (ISI). Response options range from 0 (not at all worried) to 4 (very much worried), with total scores ranging from 0 to 28 and higher scores indicating more severe insomnia.

  Change from baseline to mid-treatment (week 4) to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups

• Drinking quantity

  Assessed using Timeline Followback and Daily Drinking Questionnaire. Typical weekly drinking quantity estimates will be summed to create a "drinks per week" total score, which will be used as our outcome variable.

  Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups

• Alcohol-related consequences

  Assessed using the Drinker Inventory of Consequences (DrINC). Scores range from 0 to 120, with higher scores indicating more consequences. The common consequence subscale scores range from 0 to 18.

  Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups

Secondary Outcomes (9)

• Treatment willingness (alcohol)

  Change from baseline to post-treatment (week 6)

• Alcohol craving

  Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups

• Negative emotionality

  Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups

• Response inhibition

  Change from baseline to post (week 6) to 3-month follow-up

• Working memory

  Change from baseline to post (week 6) to 3-month follow-up

Study Arms (2)

CBT-I

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy for Insomnia

Waitlist control

NO INTERVENTION

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

Interventions

Cognitive Behavioral Therapy for Insomnia 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.

Also known as: CBT-I

CBT-I

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• ≥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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Mary Beth Miller Miller, PhD

CONTACT

573-882-1813; millmary@health.missouri.edu

Rebecca Patterson, BSc

CONTACT

573-882-8598; rap5z6@umsystem.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: PI Miller and study therapists will be blinded to assessment outcomes, and assessment RAs will be blinded to participant condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Subjects will be randomized to Cognitive Behavioral Therapy for Insomnia (CBT-I) or waitlist control.

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 29, 2024
• Study Start: March 2, 2024
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

US (1)