Recruiting

Observational Study

Sponsor:

University of Missouri-Columbia

Code:

NCT06286774

Conditions

Insomnia

Alcohol; Harmful Use

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Interventions

Cognitive Behavioral Therapy for Insomnia

Study Details

Brief summary:

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

Conditions

Insomnia

Alcohol; Harmful Use

Study ID

NCT06286774

Start date

Mar 2, 2024

Status verified date

Jul, 2025

Completion date

May 30, 2028

Anticipated

Primary completion date

May 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

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

Study Design

Enrollment

256 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBT-I

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

no intervention: Waitlist control

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

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.

Primary outcome measure

  • Insomnia Symptoms [ Time Frame: Change from baseline to mid-treatment (week 4) to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups ]
  • Drinking quantity [ Time Frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups ]
  • Alcohol-related consequences [ Time Frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups ]

Central Contacts and Locations

Central contacts

Mary Beth Miller Miller, PhD

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

Rebecca Patterson, BSc

573-882-8598rap5z6@umsystem.edu

Locations

University of Missouri-Columbia

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Mary Beth Miller, PhD

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

Rebecca Patterson, BSc

573-882-8598rap5z6@umsystem.edu

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Jul 22, 2025

Last verified

Jul, 2025

Keywords

  • alcohol
  • drinking
  • sleep
  • insomnia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2025-07-22.