Sleep as a Mechanism of Change in Alcohol Use

Part of paid clinical trials in Columbia, Missouri.

Sponsor
University of Missouri-Columbia
Study ID
NCT06286774
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 49 Years
Healthy Volunteers
Accepted

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.

Study Details

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

Key Dates

Start date
Mar 2, 2024
Status verified
Jul 2025
Primary completion
May 30, 2028
Completion
May 30, 2028

Study Design

Enrollment
256 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Missouri-ColumbiaColumbiaMissouri65212
Mary Beth Miller, PhD
573-882-1813
Rebecca Patterson, BSc
573-882-8598

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