Sleep as a Mechanism of Change in Alcohol Use
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Behavioral Therapy for Insomnia.
- Who it may be relevant to
- Registry conditions: Insomnia, Alcohol; Harmful Use. Basic parameters: 18 years — 49 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sleep as a Mechanism of Change in Alcohol Use Outcomes Among Heavy-Drinking Adults
Overview
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.
Interventions
- Behavioral Cognitive Behavioral Therapy for Insomnia
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 ni
Primary outcome measures
- 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]
- Drinking quantity [Time frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups]
- Alcohol-related consequences [Time frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups]
Secondary outcome measures (9)
- Treatment willingness (alcohol) [Time frame: Change from baseline to post-treatment (week 6)]
- Alcohol craving [Time frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups]
- Negative emotionality [Time frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups]
- Response inhibition [Time frame: Change from baseline to post (week 6) to 3-month follow-up]
- Working memory [Time frame: Change from baseline to post (week 6) to 3-month follow-up]
- Delay discounting [Time frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups]
- Alcohol to help with sleep [Time frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups]
- Heartrate variability [Time frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups]
- Dysfunctional Beliefs and Attitudes about Sleep Scale [Time frame: Change from baseline to post-treatment (week 6) to 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Missouri-Columbia — Columbia
Identifiers
NCT: NCT06286774 · 2096884