Insomnia Clinical Trial
— ReTRAINOfficial 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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Missouri-Columbia | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Missouri-Columbia |
United States,
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 |
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