Research Evaluating Sleep & Trends for Universal Prevention

NCT04783519 | Completed Results

• 2 other identifiers: STUDY000125385R34AA026909-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Alcohol Use, Unspecified; Marijuana Use

Keywords

Insomnia; Alcohol Use; Marijuana Use; Young Adults

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Daily Marijuana Questionnaire

  Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)

• Marijuana-Related Consequences

  Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)

Study Arms (3)

BASICS + SLEEP

EXPERIMENTAL

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); Behavioral: Brief Alcohol Screening and Intervention for College Students (BASICS)

BASICS

ACTIVE COMPARATOR

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)

Assessment Only Control

NO 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.

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.

BASICS + SLEEP

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.

Also known as: BASICS

BASICS; BASICS + SLEEP

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

The Center for the Study of Health and Risk Behaviors

Seattle, Washington, 98105, United States

Location

Related Publications (5)

• 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.

  PMID: 22946736 BACKGROUND

• 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.

  PMID: 21263078 BACKGROUND

• 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.

  PMID: 11414347 BACKGROUND

• 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.

  PMID: 9735576 BACKGROUND

• 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.

  PMID: 22250775 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Alcohol Drinking; Marijuana Use

Interventions

Ethanol; Mass Screening; Methods

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Drinking Behavior; Behavior; Substance-Related Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Limitations and Caveats

All study data were collected during the Covid-19 pandemic, which may have impacted substance use and insomnia symptoms among young adult participants. Additional limitations include relatively small sample size in each condition for this preliminary (pilot feasibility) RCT and slightly higher than anticipated attrition for the 3-month follow-up. All findings are based on self-report of alcohol and cannabis use and sleep symptoms.

Results Point of Contact

• Title: Mary Larimer
• Organization: University of Washington

larimer@uw.edu

(206) 543-3513

Study Officials

• Mary E Larimer, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: March 5, 2021
• Study Start: August 17, 2021
• Primary Completion: November 8, 2022
• Study Completion: July 31, 2023
• Last Updated: June 7, 2024
• Results First Posted: June 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)