Brief Interventions for Alcohol, Cannabis, and Sleep in Young Adults
This study, called the Rest-Up RCT, is looking for young adults (ages 18-29) who live in Washington State and experience problems with insomnia, alcohol use, and marijuana use. It aims to see if brief interventions can help reduce alcohol and cannabis misuse and improve sleep. You would need to have an Insomnia Severity Index (ISI) score of 10 or higher. The study will test two types of behavioral interventions: Brief Behavioral Therapy for Insomnia (BBTI) and Brief Alcohol Screening and Intervention for College Students (BASICS), compared to an Attention Control group. Researchers will measure changes in your insomnia, sleep-related impairment, and alcohol use over 18 months to see if these interventions are successful. The study plans to enroll 800 participants, but its current status is unclear.
- Study design
- This is an interventional study planning to enroll 800 participants. It compares two behavioral interventions (BBTI and BASICS) against an Attention Control group.
- What's involved
- Participants will receive either two in-person sessions and two telephone boosters for BBTI, or personalized feedback for BASICS, or four weekly 20-minute check-ins for Attention Control. Outcomes will be measured at several points over 18 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 18 months after the start of the study, with measurements taken at 7 weeks, 3 months, 6 months, 12 months, and 18 months.
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Brief Interventions to Reduce Comorbid Alcohol and Cannabis Misuse and Sleep Impairment in Young Adults (Rest-Up RCT)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Mary E Larimer, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Washington
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Insomnia Severity Index (ISI)Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline), 6 Month Follow-up (6 months post-Baseline), 12 Month Follow-up (12 months post-Baseline), 18 Month Follow-up (18 months post-Baseline)
The Insomnia Severity Index is a 7-item measure that assesses the severity of both nighttime and daytime aspects of insomnia. Response options utilized a 5-point Likert scale ranging from 0-4 where "0" reflected low symptom endorsement and "4" reflected high symptom endorsement. Responses across the 7 items are summed to create a Total Score. Total Scores range from 0 to 28. Total scores of 0-7=No clinically significant insomnia, 8-14=subthreshold insomnia, 15-21=clinical insomnia (moderate severity), and 22-28=clinical insomnia (severe).
- Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI)Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline), 6 Month Follow-up (6 months post-Baseline), 12 Month Follow-up (12 months post-Baseline), 18 Month Follow-up (18 months post-Baseline)
The Patient-Reported Outcomes Information System Short Form v1.0 Sleep Related Impairment 8a (8-items) assesses self-reported perceptions of impairment due to sleep problems. Response options range from 1=Not at all to 5=Very much and are summed to create a raw score (range 8-40). Raw scores are transformed to T-scores with a population mean of 50 and a standard deviation (SD) of 10, where higher scores indicate greater impairment due to sleep problems. For example, a T-score of 60 is one SD worse than average, whereas a T-score of 40 is one SD better than average.
- Quantity/Frequency/Peak Alcohol Use Index (QFP) peak itemBaseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline), 6 Month Follow-up (6 months post-Baseline), 12 Month Follow-up (12 months post-Baseline), 18 Month Follow-up (18 months post-Baseline)
The Quantity Frequency Peak Alcohol Use Index was used to assess the peak number of standard drinks consumed on their heaviest drinking occasion over the previous month.
- Quantity/Frequency/Peak Alcohol Use Index (QFP) quantity itemBaseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline), 6 Month Follow-up (6 months post-Baseline), 12 Month Follow-up (12 months post-Baseline), 18 Month Follow-up (18 months post-Baseline)
The Quantity Frequency Peak Alcohol Use Index was used to assess typical drinking quantity using the number of drinks consumed during a typical drinking occasion over the previous month.
- Quantity/Frequency/Peak Alcohol Use Index (QFP) frequency itemBaseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline), 6 Month Follow-up (6 months post-Baseline), 12 Month Follow-up (12 months post-Baseline), 18 Month Follow-up (18 months post-Baseline)
The Quantity Frequency Peak Alcohol Use Index was used to assess the frequency of drinking over a typical week over the previous month. Response options range from 0=I do not drink at all to 7=Every day.
- Daily Drinking Questionnaire (DDQ)Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline), 6 Month Follow-up (6 months post-Baseline), 12 Month Follow-up (12 months post-Baseline), 18 Month Follow-up (18 months post-Baseline)
The Daily Drinking Questionnaire assesses the typical number of drinks consumed on each day of a typical week over the previous month. Responses were summed to create a total score of overall number of standard drinks consumed over a typical week.
- Rutgers Alcohol Problems IndexBaseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline), 6 Month Follow-up (6 months post-Baseline), 12 Month Follow-up (12 months post-Baseline), 18 Month Follow-up (18 months post-Baseline)
The Rutgers Alcohol Problem Index (23 items) assessed negative consequences related to drinking. Two items were added to assess driving after drinking 2 or more drinks and 4 or more drinks. Response options range from 0=Never to 4=More than 10 times. Responses were summed to create a total score of problems experienced in the previous 3 months. Possible scores ranged from 0 to 100.