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Behavioral Intervention

Brief Behavioral Therapy for Insomnia (BBTI) for Cannabis Use (REST-UP Trial)

N/A

Waitlist Available

Led By Mary E Larimer, PhD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up past 3 months

Awards & highlights

REST-UP Trial Summary

This trial will help develop a way to reduce heavy drinking, marijuana use, and sleep problems all at once in young adults.

Eligible Conditions

Cannabis Use
Insomnia
Alcohol Use Disorder

REST-UP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ past 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~past 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and past 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Daily Drinking Questionnaire (DDQ)

Insomnia Severity Index (ISI)

Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI)

+2 more

Secondary outcome measures

Daily Marijuana Questionnaire

Marijuana-Related Consequences

REST-UP Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: BASICS + SLEEPExperimental Treatment2 Interventions

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.

Group II: BASICSActive Control1 Intervention

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.

Group III: Assessment Only ControlActive Control1 Intervention

Participants in Assessment Only Control (AOC) condition will complete all assessments (including survey, daily, actigraphy) at the same time as participants in the 2 active interventions. AOC will also attend an in-person meeting to verify identity, provide rationale for daily monitoring, control for time/attention, and participants in all conditions including AOC will receive referrals for community services to address alcohol and MJ use, sleep, and other mental health concerns. No participants will be deprived of services; use of outside services will be tracked to assist with interpretation of outcomes. AOC condition will be offered BASICS + SLEEP after 3-month follow-up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brief Alcohol Screening and Intervention for College Students (BASICS)

2021

N/A

~150

Brief Behavioral Therapy for Insomnia (BBTI)

2021

N/A

~200