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

Primary Purpose

Insomnia, Alcohol Use, Unspecified, Marijuana Use

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Behavioral Therapy for Insomnia (BBTI)
Brief Alcohol Screening and Intervention for College Students (BASICS)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insomnia focused on measuring Insomnia, Alcohol Use, Marijuana Use, Young Adults

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Center for the Study of Health and Risk Behaviors

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

BASICS + SLEEP

BASICS

Assessment Only Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Insomnia Severity Index (ISI)
7-item measure assessing insomnia severity with response options ranging from 0 to 4 where higher score indicate greater insomnia symptoms. Items are summed to create total scores where scores of 0-7=No clinically significant insomnia, 8-14=subthreshold insomnia, 15-21=clinical insomnia (moderate severity), and 22-28=clinical insomnia (severe).
Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI)
8-item measure assessing self-reported perceptions of impairment due to sleep problems. Response options range from 1=Not at all to 5=Very much. Responses are summed to create a raw score with higher scores indicating greater impairment.
Quantity/Frequency/Peak Alcohol Use Index (QFP)
Measures the peak quantity of alcohol consumed on the heaviest drinking occasion measured in number of standard drinks.
Quantity/Frequency/Peak Alcohol Use Index (QFP)
Measures typical quantity of alcohol consumed on a typical drinking occasion measured in number of standard drinks.
Quantity/Frequency/Peak Alcohol Use Index (QFP)
Measures the typical frequency of drinking occasions per week over the previous 30 days. Response options range from 0=I do not drink at all to 7=Every day.
Daily Drinking Questionnaire (DDQ)
Measures the typical number of standard drinks consumed on each day of a typical week over the previous month. Totals for each day are summed to create a total drinks per week score.
Rutgers Alcohol Problems Index
23 items assessing negative consequences related to drinking. 2 items were added to assess driving while impaired. Response options range from 0=Never to 4=More than 10 times. Responses are recoded to create binary scores where 0=did not happen in the previous 3 months and 1=happened in the previous 3 months. Binary scores are summed to create a total score of number of problems experienced in the previous 3 months.

Secondary Outcome Measures

Daily Marijuana Questionnaire
Measures number of hours spent high on each day of a typical week over the previous month. Responses are summed to create a total score of hours spent high over a typical week in the previous months.
Marijuana-Related Consequences
25-item measure assessing consequences related to marijuana use. Response options range from 0=Never to 4=More than 10 times. Responses are recoded to create binary scores where 0=did not happen in the previous 3 months and 1=happened in the previous 3 months. Binary scores are summed to create a total score of number of problems experienced in the previous 3 months.

Full Information

First Posted
February 2, 2021
Last Updated
June 12, 2023
Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04783519
Brief Title
Research Evaluating Sleep & Trends for Universal Prevention
Acronym
REST-UP
Official Title
Research Evaluating Sleep & Trends for Universal Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
November 8, 2022 (Actual)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Alcohol Use, Unspecified, Marijuana Use
Keywords
Insomnia, Alcohol Use, Marijuana Use, Young Adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BASICS + SLEEP
Arm Type
Experimental
Arm Description
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.
Arm Title
BASICS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Assessment Only Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Behavioral Therapy for Insomnia (BBTI)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Alcohol Screening and Intervention for College Students (BASICS)
Other Intervention Name(s)
BASICS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
7-item measure assessing insomnia severity with response options ranging from 0 to 4 where higher score indicate greater insomnia symptoms. Items are summed to create total scores where scores of 0-7=No clinically significant insomnia, 8-14=subthreshold insomnia, 15-21=clinical insomnia (moderate severity), and 22-28=clinical insomnia (severe).
Time Frame
past 2 weeks
Title
Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI)
Description
8-item measure assessing self-reported perceptions of impairment due to sleep problems. Response options range from 1=Not at all to 5=Very much. Responses are summed to create a raw score with higher scores indicating greater impairment.
Time Frame
past 7 days
Title
Quantity/Frequency/Peak Alcohol Use Index (QFP)
Description
Measures the peak quantity of alcohol consumed on the heaviest drinking occasion measured in number of standard drinks.
Time Frame
past 30 days
Title
Quantity/Frequency/Peak Alcohol Use Index (QFP)
Description
Measures typical quantity of alcohol consumed on a typical drinking occasion measured in number of standard drinks.
Time Frame
past 30 days
Title
Quantity/Frequency/Peak Alcohol Use Index (QFP)
Description
Measures the typical frequency of drinking occasions per week over the previous 30 days. Response options range from 0=I do not drink at all to 7=Every day.
Time Frame
past 30 days
Title
Daily Drinking Questionnaire (DDQ)
Description
Measures the typical number of standard drinks consumed on each day of a typical week over the previous month. Totals for each day are summed to create a total drinks per week score.
Time Frame
past month
Title
Rutgers Alcohol Problems Index
Description
23 items assessing negative consequences related to drinking. 2 items were added to assess driving while impaired. Response options range from 0=Never to 4=More than 10 times. Responses are recoded to create binary scores where 0=did not happen in the previous 3 months and 1=happened in the previous 3 months. Binary scores are summed to create a total score of number of problems experienced in the previous 3 months.
Time Frame
past 3 months
Secondary Outcome Measure Information:
Title
Daily Marijuana Questionnaire
Description
Measures number of hours spent high on each day of a typical week over the previous month. Responses are summed to create a total score of hours spent high over a typical week in the previous months.
Time Frame
past month
Title
Marijuana-Related Consequences
Description
25-item measure assessing consequences related to marijuana use. Response options range from 0=Never to 4=More than 10 times. Responses are recoded to create binary scores where 0=did not happen in the previous 3 months and 1=happened in the previous 3 months. Binary scores are summed to create a total score of number of problems experienced in the previous 3 months.
Time Frame
past 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary E Larimer, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for the Study of Health and Risk Behaviors
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22946736
Citation
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.
Results Reference
background
PubMed Identifier
21263078
Citation
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.
Results Reference
background
PubMed Identifier
11414347
Citation
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.
Results Reference
background
PubMed Identifier
9735576
Citation
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.
Results Reference
background

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Research Evaluating Sleep & Trends for Universal Prevention

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