Research Evaluating Sleep & Trends for Universal Prevention

Not Applicable

Completed

• Conditions: Marijuana Use; Insomnia; Alcohol Use, Unspecified
• Interventions: Behavioral: Brief Behavioral Therapy for Insomnia (BBTI); Behavioral: Brief Alcohol Screening and Intervention for College Students (BASICS)

• Registration Number: NCT04783519
• Lead Sponsor: University of Washington

Brief Summary

This study is designed to develop an integrated intervention to reduce alcohol and marijuana use and consequences and improve sleep among young adults with comorbid heavy episodic drinking, marijuana use, and sleep impairment.

Detailed Description

This study is designed to develop an integrated intervention to reduce alcohol and MJ use and consequences and improve sleep among young adults (YA) with comorbid heavy episodic drinking (HED), MJ use, and sleep impairment. HED in YA is an important public health problem, with consequences including accidental injury and death, academic or work problems, unsafe and unwanted sex, and development of alcohol use disorders. Many YA with HED also use MJ, often simultaneously, and experience increased harm as a result. Sleep impairment is common and problematic among YA, identified as the 3rd leading barrier to academic success for students and an important risk factor for mental health problems and suicide in YA. Alcohol use has been linked to impaired sleep in adolescent, YA, college, and older adult populations, with bidirectional causal links between alcohol use and impaired sleep, including negative physiological effects of alcohol on the sleep cycle (e.g., suppression of REM sleep), use of alcohol to promote sleep onset which can both increase alcohol use and resultant sleep impairment, and poor sleep hygiene including delayed and variable sleep-wake timing associated with cyclical patterns of alcohol use during evening and/or weekend social events. Comorbidity of HED and sleep impairment is associated with increased consequences of alcohol use, and exacerbates risk of accidents (including automobile accidents), impaired decision-making, and work and academic difficulties. Similar bidirectional relations exist with MJ use and sleep. Despite risks and consequences, alcohol and MJ prevention programs rarely target sleep directly, and the majority of YA interventions for sleep either focus on sleep hygiene broadly in the absence of specific strategies shown to improve sleep or reduce alcohol or MJ use, or have been relatively intensive interventions with insufficient sample size to truly evaluate impacts on sleep or related comorbid alcohol or MJ use. The current study addresses these gaps through developing and evaluating feasibility and preliminary efficacy of a brief, integrated intervention combining efficacious brief motivational feedback and skills for reducing HED and MJ use and consequences (BASICS) with Brief Behavioral Therapy for Insomnia (SLEEP) shown to improve sleep in other populations. Feasibility and efficacy will be evaluated over a 3-month period, using surveys and daily diaries to assess alcohol, MJ, and sleep at post-intervention and 3- months. Specific aims are: 1) Assess feasibility, acceptability, and preliminary efficacy BASICS + SLEEP in reducing alcohol use and consequences, improving sleep, and weakening daily and lagged (next day) relationships between alcohol and MJ use and sleep impairment; and 2) Use diary data to explore daily and lagged relationships between alcohol use, MJ, sleep impairment, and unique YA contextual factor to further inform prevention of comorbid alcohol use, MJ, and sleep impairment.

Study Timeline

• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-05
• Study Start: 2021-08-17
• Primary Completion: 2022-11-08
• Study Completion: 2023-07-31
• Results First Submitted: 2024-03-27
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-10
• Last Update Submitted: 2024-05-10
• Results First Posted: 2024-06-07
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Age 18-24, score on the ISI of 10 or higher, reporting at least one heavy drinking episode in the past two weeks, use of marijuana at least once in the past month

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Exclusion Criteria

• Not meeting the Inclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BASICS + SLEEP	Brief Alcohol Screening and Intervention for College Students (BASICS)	The BASICS + SLEEP intervention will integrate BASICS feedback and the Motivational Interviewing (MI) process described in the BASICS arm with Brief Behavioral Therapy for Insomnia (BBTI) content and materials. The BASICS + SLEEP intervention will be implemented in 2 sessions of 45-75 minutes and 2 telephone booster sessions. We will follow BBTI procedures, including provision of a physiological rationale for insomnia and the importance of behavioral strategies to regulate sleep; introduction of sleep hygiene; discussion of factors that can impede duration and quality of sleep; introduction of sleep restriction and stimulus control strategies and negotiation of an initial sleep restriction schedule; and follow-up evaluation of success and continued refinement to achieve sleep efficiency goals. Booster contacts serve as opportunities to adjust the sleep restriction schedule, problem-solve challenges, and further build motivation.
BASICS	Brief Alcohol Screening and Intervention for College Students (BASICS)	The BASICS condition will meet for 2 sessions of 45-75 minutes. Content depends on the degree to which participants discuss the feedback, have questions, and/or explore behavior change options. Therapists review feedback components with participants, eliciting personally relevant reasons to change as domains are explored. When the participant is ambivalent about change, therapists work with them to explore and resolve that ambivalence. The method is non-confrontational and utilizes exploration of personalized graphic feedback (i.e., frequency, quantity, and peak use alongside perceived and actual norms for alcohol/MJ use) to increase motivation for change by highlighting ways alcohol and/or marijuana use could be incongruent with goals or values. Beliefs, expectations, and motives for use are discussed as are strategies to minimize risks and consequences. Booster sessions address questions and problem-solve challenges that have arisen since the session.
BASICS + SLEEP	Brief Behavioral Therapy for Insomnia (BBTI)	The BASICS + SLEEP intervention will integrate BASICS feedback and the Motivational Interviewing (MI) process described in the BASICS arm with Brief Behavioral Therapy for Insomnia (BBTI) content and materials. The BASICS + SLEEP intervention will be implemented in 2 sessions of 45-75 minutes and 2 telephone booster sessions. We will follow BBTI procedures, including provision of a physiological rationale for insomnia and the importance of behavioral strategies to regulate sleep; introduction of sleep hygiene; discussion of factors that can impede duration and quality of sleep; introduction of sleep restriction and stimulus control strategies and negotiation of an initial sleep restriction schedule; and follow-up evaluation of success and continued refinement to achieve sleep efficiency goals. Booster contacts serve as opportunities to adjust the sleep restriction schedule, problem-solve challenges, and further build motivation.

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)	Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 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).
Quantity/Frequency/Peak Alcohol Use Index (QFP) Peak Item	Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 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 Item	Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 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 Item	Baseline, 3 Month Follow-up (3 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.
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)	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.
Daily Drinking Questionnaire (DDQ)	Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 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 Index	Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 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.

Secondary Outcome Measures

Name	Time	Method
Daily Marijuana Questionnaire	Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)	The Daily Marijuana Questionnaire was used to assess hours high from cannabis use on each day over a typical week in the past month. Items were summed to create a total score of overall number of hours spent high during a typical week.
Marijuana-Related Consequences	Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)	Marijuana Consequences were assessed with a 29-item measure assessing consequences related to marijuana use. Response options range from 0=Never to 4=More than 10 times. Scores are summed to create a total score of problems experienced in the previous 3 months. Possible scores ranged from 0 to 116.

Trial Locations

Locations (1)

The Center for the Study of Health and Risk Behaviors; 🇺🇸 Seattle, Washington, United States