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Cognitive Behavioral Therapy for Insomnia and Alcohol Use

This study is looking at how treating insomnia might help reduce heavy drinking. It's testing Cognitive Behavioral Therapy for Insomnia (CBT-I), a type of talk therapy, in adults who drink heavily and also have insomnia. The study will compare CBT-I to a waitlist control group. Researchers will measure changes in insomnia symptoms, how much alcohol participants drink, and any alcohol-related problems. They hope to see if improving sleep can lead to better outcomes for alcohol use. To join, you must be between 18 and 49 years old, report heavy drinking, and meet criteria for both Alcohol Use Disorder and Insomnia Disorder. The study aims to enroll 256 participants.

Study design
This interventional study will randomly assign 256 participants to either Cognitive Behavioral Therapy for Insomnia or a waitlist control group.
What's involved
If you are assigned to CBT-I, you will attend 1-hour individual sessions once a week for five weeks.
Compensation
Not stated in the trial record.
Follow-up
Outcomes will be assessed weekly during treatment, at the end of treatment, and at 1-, 3-, and 6-month follow-ups.

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NCT06286774

Sleep as a Mechanism of Change in Alcohol Use

Recruiting
NAAges 18–49InterventionalTreatment
University of Missouri-Columbia
~256 participants
Updated 2025-07-22 on ClinicalTrials.gov
What's tested:Cognitive Behavioral Therapy for Insomnia

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Insomnia Symptoms
Measured over Change from baseline to mid-treatment (week 4) to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
+2 more outcomes measured

Conditions

Insomnia
Alcohol; Harmful Use

Explore related trials

Alcohol use disorderInsomnia

Where it's being run

1 sites across 1 states
Missouri1

Who to contact

Mary Beth Miller Miller, PhD
[email protected]
573-882-1813
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

≥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

What this trial measures

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

    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.

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

    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.

  • Alcohol-related consequencesChange from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups

    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.