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
- Alcohol; Harmful Use
- Insomnia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 49 Years
- Healthy Volunteers
- Accepted
Interventions
- Cognitive Behavioral Therapy for Insomnia — BEHAVIORALCognitive 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-IIndividual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
- No Intervention: Waitlist controlControl 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
- Mary Beth Miller Miller, PhD573-882-1813
- Rebecca Patterson, BSc573-882-8598
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Missouri-Columbia | Columbia | Missouri | 65212 |
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