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This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-I | Experimental | Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks. |
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| Waitlist control | No Intervention | Control participants will receive CBT-I at the end of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Beth Miller Miller, PhD | Contact | 573-882-1813 | millmary@health.missouri.edu | |
| Rebecca Patterson, BSc | Contact | 573-882-8598 | rap5z6@umsystem.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri-Columbia | Recruiting | Columbia | Missouri | 65212 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Subjects will be randomized to Cognitive Behavioral Therapy for Insomnia (CBT-I) or waitlist control.
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PI Miller and study therapists will be blinded to assessment outcomes, and assessment RAs will be blinded to participant condition.
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| D001523 |
| Mental Disorders |