InsomniaReTRAINNCT06286774
Sleep as a Mechanism of Change in Alcohol Use
A study testing Cognitive Behavioral Therapy for Insomnia in people with Insomnia and Alcohol; Harmful Use, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Alcohol; Harmful Use
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2024to 30 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- ≥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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Missouri-Columbia
Columbia, Missouri, 65212
Mary Beth Miller, PhD, 573-882-1813, millmary@health.missouri.edu
Rebecca Patterson, BSc, 573-882-8598, rap5z6@umsystem.edu
About this study
Official title: Sleep as a Mechanism of Change in Alcohol Use Outcomes Among Heavy-Drinking Adults
This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.
Read the 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.
- Conditions
- Insomnia, Alcohol; Harmful Use
- Being tested
- Cognitive Behavioral Therapy for Insomnia
- Keywords
- alcohol, drinking, sleep, insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
Also called CBT-I
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Experimental | Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Waitlist control | No intervention | Control participants will receive CBT-I at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to mid-treatment (week 4) to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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.
Measured: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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.
Measured: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
Secondary outcomes (9)
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.
Measured: Change from baseline to post-treatment (week 6)
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.
Measured: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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.
Measured: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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.
Measured: Change from baseline to post (week 6) to 3-month follow-up
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.
Measured: Change from baseline to post (week 6) to 3-month follow-up
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.
Measured: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
Alcohol to help with sleep
Assessed using daily sleep diaries. The outcome will be percentage of days using alcohol to help with sleep.
Measured: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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.
Measured: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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.
Measured: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start2 Mar 2024
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to Cognitive Behavioral Therapy for Insomnia (CBT-I) or waitlist control.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary E Miller, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286774
- Sponsor's protocol ID
- 2096884
- Acronym
- ReTRAIN
- Status last verified
- Sep 2026
- First submitted
- 2 Feb 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep as a Mechanism of Change in Alcohol Use Outcomes Among Heavy-Drinking Adults
- ClinicalTrials.gov ID
- NCT06286774
- Acronym / sponsor ID
- ReTRAIN / 2096884
- Conditions
- Insomnia, Alcohol; Harmful Use
- Keywords
- alcohol, drinking, sleep, insomnia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 2 Mar 2024 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized to Cognitive Behavioral Therapy for Insomnia (CBT-I) or waitlist control.
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Experimental | Behavioral: Cognitive Behavioral Therapy for InsomniaIndividual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks. |
| Waitlist control | No intervention | –Control participants will receive CBT-I at the end of the study. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- ≥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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for InsomniaAlso: CBT-ICognitive 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. | Behavioural | CBT-I |
Primary outcome
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
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.
Drinking quantity
Time frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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.
Alcohol-related consequences
Time frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia in people with Insomnia and Alcohol; Harmful Use, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Beth Miller Miller, PhD (573-882-1813, millmary@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.