Research Evaluating Sleep & Trends for Universal Prevention (REST-UP)

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • The Center for the Study of Health and Risk Behaviors

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Exclusion Criteria:

• Not meeting the Inclusion Criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BASICS + SLEEP; 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.	Behavioral: Brief Behavioral Therapy for Insomnia (BBTI); 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.; Behavioral: Brief Alcohol Screening and Intervention for College Students (BASICS); 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.; Other Names: BASICS
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.	Behavioral: Brief Alcohol Screening and Intervention for College Students (BASICS); 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.; Other Names: BASICS
No Intervention: Assessment Only Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index (ISI)	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).	Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)
Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI)	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.	Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)
Quantity/Frequency/Peak Alcohol Use Index (QFP) Peak Item	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.	Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)
Quantity/Frequency/Peak Alcohol Use Index (QFP) Quantity Item	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.	Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)
Quantity/Frequency/Peak Alcohol Use Index (QFP) Frequency Item	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.	Baseline, 3 Month Follow-up (3 months post-Baseline)
Daily Drinking Questionnaire (DDQ)	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.	Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)
Rutgers Alcohol Problems Index	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.	Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Marijuana Questionnaire	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.	Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)
Marijuana-Related Consequences	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.	Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Mary E Larimer, PhD, University of Washington

Publications and helpful links

General Publications

• Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24. doi: 10.1080/15402002.2012.636266.
• Marlatt GA, Baer JS, Kivlahan DR, Dimeff LA, Larimer ME, Quigley LA, Somers JM, Williams E. Screening and brief intervention for high-risk college student drinkers: results from a 2-year follow-up assessment. J Consult Clin Psychol. 1998 Aug;66(4):604-15. doi: 10.1037//0022-006x.66.4.604.
• Larimer ME, Turner AP, Anderson BK, Fader JS, Kilmer JR, Palmer RS, Cronce JM. Evaluating a brief alcohol intervention with fraternities. J Stud Alcohol. 2001 May;62(3):370-80. doi: 10.15288/jsa.2001.62.370.
• Troxel WM, Germain A, Buysse DJ. Clinical management of insomnia with brief behavioral treatment (BBTI). Behav Sleep Med. 2012 Oct;10(4):266-79. doi: 10.1080/15402002.2011.607200.
• Buysse DJ, Germain A, Moul DE, Franzen PL, Brar LK, Fletcher ME, Begley A, Houck PR, Mazumdar S, Reynolds CF 3rd, Monk TH. Efficacy of brief behavioral treatment for chronic insomnia in older adults. Arch Intern Med. 2011 May 23;171(10):887-95. doi: 10.1001/archinternmed.2010.535. Epub 2011 Jan 24. Erratum In: JAMA Intern Med. 2019 Aug 1;179(8):1152.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2021
• Primary Completion (Actual): November 8, 2022
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Insomnia; Young Adults; Alcohol Use; Marijuana Use
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Nervous System Diseases; Substance-Related Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Alcohol Drinking; Sleep Initiation and Maintenance Disorders; Marijuana Abuse; Marijuana Use
• Other Study ID Numbers: STUDY00012538; 5R34AA026909-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No