Brief Interventions to Reduce Comorbid Alcohol and Cannabis Misuse and Sleep Impairment in Young Adults (Rest-Up RCT)

Conditions

• Alcohol Use
• Insomnia
• Marijuana Use

Eligibility Criteria

Sex

ALL

Age

18 Years - 29 Years

Healthy Volunteers

Not accepted

Interventions

• Brief Behavioral Therapy for Insomnia (BBTI) — BEHAVIORAL
  Brief Behavioral Therapy for Insomnia (BBTI) focuses primarily on stimulus control and sleep restriction as well as sleep hygiene recommendations delivered over 2 in-person sessions and 2 brief telephone boosters and is designed to be implemented by nonspecialists in primary care or other non-clinical settings. The intervention is manualized, and clients utilize sleep diaries and workbook assignments to consolidate recommendations.
• Brief Alcohol Screening and Intervention for College Students (BASICS) — BEHAVIORAL
  Brief Alcohol Screening and Intervention for College Students (BASICS) is a manualized brief intervention targeting alcohol use and consequences among high risk drinkers and includes both personalized feedback regarding drinking norms, consequences, and motives for drinking, as well as protective behavioral skills for reducing heavy episodic drinking and related consequences. BASICS is delivered in a motivational interviewing (MI) style (Miller \& Rollnick, 2002) to enhance intrinsic motivation to change drinking and implement protective behavioral strategies. BASICS has been adapted to target marijuana use and has been adapted for use with a variety of populations.
• Attention Control — BEHAVIORAL
  Attention Control is comprised of 4 weekly 20-minute check-ins with a study therapists regarding the daily monitoring and mood/functioning. Referrals for additional services will be provided as needed.

Study Details

This study is designed to evaluate 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.

Key Dates

Start date

Jul 2, 2025

Status verified

Apr 2026

Primary completion

Apr 1, 2029

Completion

Apr 1, 2029

Study Design

Enrollment

800 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: BASICSSLEEP
  The BASICSSLEEP 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. The investigators 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.
• Active Comparator: 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.
• Active Comparator: SLEEP
  The SLEEP intervention will be implemented in 2 sessions of 45-75 minutes and 2 telephone booster sessions. The investigators 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.
• Other: Attention Control
  Attention Control (AC) participants complete all assessments (survey, daily, Fitbit, BAC) yoked to participants in the 3 active interventions, and attend the Zoom training to verify identity, orient to the Fitbit \& BAC monitoring, and provide rationale and instructions for daily diaries. To better control for time and attention, AC participants attend 4 weekly Zoom check-ins (\~20 minutes) in which clinically trained staff inquire about challenges encountered in monitoring, observations from monitoring, check in on mood/functioning, and provide referrals as needed. All conditions including AC receive community referrals to address substance uses, sleep, and mental health concerns. No participant is deprived of services; service use is tracked to assist with interpreting outcomes. AC participants will be offered BASICSSLEEP after completing 18-month follow-up.

Primary Outcome Measure

Insomnia Severity Index (ISI) [ Time Frame: 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) ]

Central Contacts

• Mary E Larimer, Ph.D.
  206-543-3513
  [email protected]
• Nicole Fossos-Wong, B.S.
  206-685-1499
  [email protected]

Locations (1)

Find similar trials in Seattle, WA

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