[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06736444":3,"trial-entities:NCT06736444":118,"trial-summary:NCT06736444":122},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":48,"secondary_outcomes":71,"sex":78,"minimum_age":79,"maximum_age":80,"healthy_volunteers":15,"eligibility_criteria":81,"std_ages":86,"locations":88,"central_contacts":106,"overall_officials":114,"references":116,"see_also_links":117},"NCT06736444","STUDY00019900","Brief Interventions to Reduce Comorbid Alcohol and Cannabis Misuse and Sleep Impairment in Young Adults (Rest-Up RCT)","Efficacy of Brief Interventions to Reduce Comorbid Alcohol and Cannabis Misuse and Sleep Impairment in Young Adults (Rest-Up RCT)","RECRUITING","2029-04-01","2026-04","2026-04-14","2025-07-02","University of Washington","OTHER",false,"This study is designed to evaluate 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.","This study is designed to evaluate an integrated brief intervention to reduce alcohol and cannabis use and consequences and improve sleep among young adults (YA) with comorbid heavy episodic drinking (HED), cannabis misuse, and sleep impairment. HED in YA is an important public health problem; consequences include accidental injury and death, academic\u002Fwork problems, unsafe and unwanted sex, and development of alcohol use disorders. Many YA with HED also use cannabis and experience increased harm as a result. Sleep impairment is common and problematic among YA, identified as one of 5 leading barriers to academic success for students and an important risk factor for mental health problems and suicide in YA. More than 75% of YA report frequent daytime fatigue, 27% extreme distress related to sleep problems, and more than 1 in 4 are at high risk for insomnia. Alcohol use has been linked to insomnia in adolescent, YA, and older adult populations, with bidirectional causal links between alcohol use and impaired sleep. 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 cannabis use and sleep, and co-use of these substances may be particularly harmful for sleep. Despite these risks, alcohol and cannabis prevention programs rarely target sleep directly, and the majority of YA sleep interventions either focus on sleep hygiene broadly in the absence of specific strategies to improve sleep or reduce alcohol\u002Fcannabis use or have insufficient sample size and duration to truly evaluate impacts on sleep or related comorbid alcohol or cannabis use. Building on the investigators' successful R34 intervention development project, the current study addresses these gaps by evaluating efficacy of integrating a brief sleep intervention (BBTI) with an efficacious brief alcohol and cannabis intervention (BASICS\u002FCannabis BMI) to increase magnitude and duration of effects on sleep and alcohol and cannabis misuse among a diverse community sample of YA with comorbid insomnia, HED, and cannabis use. Given bidirectional influences between sleep impairment and alcohol\u002Fcannabis misuse leading to significant public health challenges for this population, an efficacious integrated treatment is imperative. Impact will be evaluated in a RCT comparing efficacy of telehealth-delivered, integrated BASICSSLEEP to BASICS\u002FBMI only (BASICS+), BBTI only (SLEEP), and Attention control (AC). Surveys and daily diaries will assess alcohol, cannabis, and sleep at baseline, post-treatment, 3-, 6-, 12-, and 18-months. Specific aims are: (1) Evaluate comparative efficacy of BASICSSLEEP, BASICS+, and SLEEP in reducing alcohol\u002Fcannabis use and consequences and improving sleep; (2) Evaluate moderators of efficacy for integrated and monotherapies; and (3) Use diary data to evaluate temporal sequencing of effects and duration\u002Fdecay over time. Findings will remedy important gaps in the literature and result in a scalable, accessible new resource to address this important and costly comorbidity.",[19,20,21],"Insomnia","Alcohol Use","Marijuana Use",[19,20,21,23],"Young Adults","INTERVENTIONAL","PREVENTION",[27],"NA",{"count":29,"type":30},800,"ESTIMATED",[32,39,44],{"type":33,"name":34,"description":35,"armGroupLabels":36},"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.",[37,38],"BASICSSLEEP","SLEEP",{"type":33,"name":40,"description":41,"armGroupLabels":42},"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.",[43,37],"BASICS+",{"type":33,"name":45,"description":46,"armGroupLabels":47},"Attention Control","Attention Control is comprised of 4 weekly 20-minute check-ins with a study therapists regarding the daily monitoring and mood\u002Ffunctioning. Referrals for additional services will be provided as needed.",[45],[49,53,56,59,62,65,68],{"measure":50,"description":51,"timeFrame":52},"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), 6 Month Follow-up (6 months post-Baseline), 12 Month Follow-up (12 months post-Baseline), 18 Month Follow-up (18 months post-Baseline)",{"measure":54,"description":55,"timeFrame":52},"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.",{"measure":57,"description":58,"timeFrame":52},"Quantity\u002FFrequency\u002FPeak 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.",{"measure":60,"description":61,"timeFrame":52},"Quantity\u002FFrequency\u002FPeak 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.",{"measure":63,"description":64,"timeFrame":52},"Quantity\u002FFrequency\u002FPeak 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.",{"measure":66,"description":67,"timeFrame":52},"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.",{"measure":69,"description":70,"timeFrame":52},"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.",[72,75],{"measure":73,"description":74,"timeFrame":52},"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.",{"measure":76,"description":77,"timeFrame":52},"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.","ALL","18 Years","29 Years",{"inclusion":82,"exclusion":84,"raw_text":85},[83],"Participants must: 1) be 18-29 years old; 2) reside in Washington State; 3) have valid email address; 4) score on the Insomnia Severity Index (ISI) of 10 or higher, indicating at least a moderate score (score of 2 or more) on one or more of the first three items of the ISI measuring difficulty falling asleep, staying asleep, or waking up too early; 5a) report at least two heavy drinking episodes (4+ drinks for women \u002Fgender diverse, 5+ for men in a 2-hour period) in the past month; or 5b) 1 heavy drinking occasion and at least 4 total drinking occasions in the past month; 6) have used cannabis 4+ times in the past month; and 7) did not participate in the R34 pilot feasibility trial on which the current RCT is based.",[],"Inclusion Criteria:\n\n* Participants must: 1) be 18-29 years old; 2) reside in Washington State; 3) have valid email address; 4) score on the Insomnia Severity Index (ISI) of 10 or higher, indicating at least a moderate score (score of 2 or more) on one or more of the first three items of the ISI measuring difficulty falling asleep, staying asleep, or waking up too early; 5a) report at least two heavy drinking episodes (4+ drinks for women \u002Fgender diverse, 5+ for men in a 2-hour period) in the past month; or 5b) 1 heavy drinking occasion and at least 4 total drinking occasions in the past month; 6) have used cannabis 4+ times in the past month; and 7) did not participate in the R34 pilot feasibility trial on which the current RCT is based.\n\nExclusion Criteria:\n\n* Participants that don't meet inclusion criteria and\u002For failure to consent to further participation.",[87],"ADULT",[89],{"facility":13,"status":8,"city":90,"state":91,"zip":92,"country":93,"contacts":94,"geoPoint":103},"Seattle","Washington","98195","United States",[95,100],{"name":96,"role":97,"phone":98,"email":99},"Rosemary Whitright","CONTACT","206-221-3640","rwhit@uw.edu",{"name":101,"role":102},"Mary E Larimer, Ph.D.","PRINCIPAL_INVESTIGATOR",{"lat":104,"lon":105},47.60621,-122.33207,[107,110],{"name":101,"role":97,"phone":108,"email":109},"206-543-3513","larimer@uw.edu",{"name":111,"role":97,"phone":112,"email":113},"Nicole Fossos-Wong, B.S.","206-685-1499","njf2@uw.edu",[115],{"name":101,"affiliation":13,"role":102},[],[],{"nct_id":4,"conditions":119,"biomarkers":121},[120,19,21],"Alcohol Consumption",[],{"nct_id":4,"found":123,"summary":124,"prompt_version":134},true,{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an interventional study planning to enroll 800 participants. It compares two behavioral interventions (BBTI and BASICS) against an Attention Control group.","completed","Brief Interventions for Alcohol, Cannabis, and Sleep in Young Adults","This study, called the Rest-Up RCT, is looking for young adults (ages 18-29) who live in Washington State and experience problems with insomnia, alcohol use, and marijuana use. It aims to see if brief interventions can help reduce alcohol and cannabis misuse and improve sleep. You would need to have an Insomnia Severity Index (ISI) score of 10 or higher. The study will test two types of behavioral interventions: Brief Behavioral Therapy for Insomnia (BBTI) and Brief Alcohol Screening and Intervention for College Students (BASICS), compared to an Attention Control group. Researchers will measure changes in your insomnia, sleep-related impairment, and alcohol use over 18 months to see if these interventions are successful. The study plans to enroll 800 participants, but its current status is unclear.","Participants will be followed for 18 months after the start of the study, with measurements taken at 7 weeks, 3 months, 6 months, 12 months, and 18 months.",126,"Participants will receive either two in-person sessions and two telephone boosters for BBTI, or personalized feedback for BASICS, or four weekly 20-minute check-ins for Attention Control. Outcomes will be measured at several points over 18 months.","Not stated in the trial record.",[34,40,45],"v2"]