Research Evaluating Sleep & Trends for Universal Prevention

Insomnia Clinical Trial

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Official title:

Research Evaluating Sleep & Trends for Universal Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04783519
• Other study ID #: STUDY00012538
• Secondary ID: 5R34AA026909-02
• Status: Completed
• Phase: N/A
• Start date: August 17, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 31, 2023
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use, Unspecified
• Insomnia
• Marijuana Abuse
• Marijuana Use
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Center for the Study of Health and Risk Behaviors	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)