Sleep as a Mechanism of Change in Alcohol Use (ReTRAIN)
Status
Conditions
Treatments
Details and patient eligibility
About
This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.
Full description
Heavy alcohol use is prevalent in the United States and results in significant physical and psychological burden. One in 10 adults in the United States reports binge drinking on a weekly basis, and few are willing to seek mental health treatment. Thus, additional strategies are needed to engage and treat individuals at risk for alcohol-related harm. Half of those who screen positive for hazardous drinking report clinically significant symptoms of insomnia. Insomnia tends to be less stigmatized than other mental health disorders, and it is one condition for which the field has highly efficacious treatment. Thus, one potential strategy to engage individuals in mental health treatment and reduce the burden of alcohol use in the United States is to target insomnia. This project aims (1) to examine change in insomnia as a mediator of insomnia treatment effects on alcohol use outcomes and sex as a moderator of those effects and (2) to identify mechanisms linking change in insomnia to alcohol use outcomes. Adults who drink alcohol and have insomnia will be randomly assigned to Cognitive Behavioral Therapy for Insomnia (CBT-I, n=112) or waitlist control (WLC, n=112). Outcomes will be assessed weekly during treatment, at the end of the active intervention period (post-treatment), and at 1-, 3-, and 6-month follow-ups.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
256 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Rebecca Patterson, BSc; Mary Beth Miller Miller, PhD
Data sourced from clinicaltrials.gov
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