Clinical trial NCT06286774: Sleep as a Mechanism of Change in Alcohol Use
Official title: Sleep as a Mechanism of Change in Alcohol Use Outcomes Among Heavy-Drinking Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Alcohol; Harmful Use
Keywords: alcohol
drinking
sleep
insomnia
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to Cognitive Behavioral Therapy for Insomnia (CBT-I) or waitlist control.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Symptoms
timeFrame: Change from baseline to mid-treatment (week 4) to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
measure: Drinking quantity
timeFrame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
measure: Alcohol-related consequences
timeFrame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
Secondary outcomes:
measure: Treatment willingness (alcohol)
timeFrame: Change from baseline to post-treatment (week 6)
measure: Alcohol craving
timeFrame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
measure: Negative emotionality
timeFrame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
measure: Response inhibition
timeFrame: Change from baseline to post (week 6) to 3-month follow-up
measure: Working memory
timeFrame: Change from baseline to post (week 6) to 3-month follow-up
measure: Delay discounting
timeFrame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
measure: Alcohol to help with sleep
timeFrame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
measure: Heartrate variability
timeFrame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
measure: Dysfunctional Beliefs and Attitudes about Sleep Scale
timeFrame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
References: