Sleep as a Mechanism of Change in Alcohol Use

Insomnia Clinical Trial

— ReTRAIN  

Official title:

Sleep as a Mechanism of Change in Alcohol Use Outcomes Among Heavy-Drinking Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06286774
• Other study ID #: 2096884
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: April 1, 2028

Study information

• Verified date: February 2024
• Source: University of Missouri-Columbia
• Contact: Mary Beth Miller Miller, PhD
• Phone: 573-882-1813
• Email: millmary[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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. Primary outcomes include insomnia severity, drinking quantity, and alcohol-related consequences. Data will be analyzed using multilevel models. The results of the proposed research will inform research and clinical practice by determining the extent to which sleep operates as a mechanism of alcohol behavior change.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 256
• Est. completion date: April 1, 2028
• Est. primary completion date: April 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol; Harmful Use
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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 night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.

Locations

Country	Name	City	State
United States	University of Missouri-Columbia	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Symptoms	Assessed using Insomnia Severity Index (ISI). Response options range from 0 (not at all worried) to 4 (very much worried), with total scores ranging from 0 to 28 and higher scores indicating more severe insomnia.	Change from baseline to mid-treatment (week 4) to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
Primary	Drinking quantity	Assessed using Timeline Followback and Daily Drinking Questionnaire. Typical weekly drinking quantity estimates will be summed to create a "drinks per week" total score, which will be used as our outcome variable.	Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
Primary	Alcohol-related consequences	Assessed using the Drinker Inventory of Consequences (DrINC). Scores range from 0 to 120, with higher scores indicating more consequences. The common consequence subscale scores range from 0 to 18.	Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
Secondary	Treatment willingness (alcohol)	Assessed using a modified Treatment Willingness Scale. Participants rate their agreement with the statement that they would seek treatment for 5 medical and 5 mental health conditions if they experienced problems related to them. Willingness to seek alcohol or drug treatment is assessed on a 0-5 scale, with higher scores indicating greater willingness.	Change from baseline to post-treatment (week 6)
Secondary	Alcohol craving	Assessed using the Penn Alcohol Craving Scale (PACS). PACS evaluates thoughts about drinking by assessing the duration, frequency, and intensity of such thoughts. Scores range 0-30, with higher scores indicating more severe craving.	Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
Secondary	Negative emotionality	Negative emotionality will be assessed as a latent construct of mood, anxiety, depression, PTSD symptoms, and difficulties with emotion regulation. Changes in individual symptoms will be reported for descriptive purposes.	Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
Secondary	Response inhibition	Assessed using the Stroop Task. Average reaction time (RT; measured from color word/color rectangle stimuli onset until a response is made) on correct trials for each trial type (control trials, congruent trials, incongruent trials) were computed as the outcomes of interest. Higher RTs indicate worse performance.	Change from baseline to post (week 6) to 3-month follow-up
Secondary	Working memory	Assessed using the N-Back Task. The dependent measure is the proportion of correct responses (yes and no) across all four blocks. Omissions are counted as errors.	Change from baseline to post (week 6) to 3-month follow-up
Secondary	Delay discounting	Assessed using the Monetary Choice Questionnaire (MCQ). Participants indicate if they would rather receive a smaller amount of money now or a greater amount of money in a specified amount of time (e.g., 100 days, 2 days). The MCQ is scored using a logarithmic subject-specific discount rate (k variable). Higher k values indicate a greater preference for smaller, immediate rewards over larger, delayed reward.	Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
Secondary	Alcohol to help with sleep	Assessed using daily sleep diaries. The outcome will be percentage of days using alcohol to help with sleep.	Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
Secondary	Heartrate variability	Assessed using Fitbit Charge 6. Heart-rate variability (HRV) is an indicator of activity in the autonomic nervous system that quantifies changes in intervals between heart beats. In general, HRV increases with increasing parasympathetic activity, then plateaus and decreases with increasing sympathetic activity.	Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
Secondary	Dysfunctional Beliefs and Attitudes about Sleep Scale	Assessed using the revised Dysfunctional Beliefs and Attitudes about Sleep Scale. Responses range from 0 to 70, with higher scores indicating more dysfunctional beliefs.	Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups