Brief Interventions to Reduce Comorbid Alcohol and Cannabis Misuse and Sleep Impairment in Young Adults (Rest-Up RCT)

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.

BEHAVIORAL

Attention Control

Attention Control is comprised of 4 weekly 20-minute check-ins with a study therapists regarding the daily monitoring and mood/functioning. Referrals for additional services will be provided as needed.

Insomnia Severity Index (ISI)

Time frame: 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)

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).

Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI)

Time frame: 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)

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.

Quantity/Frequency/Peak Alcohol Use Index (QFP) peak item

Time frame: 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)

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.

Quantity/Frequency/Peak Alcohol Use Index (QFP) quantity item

Time frame: 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)

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.

Quantity/Frequency/Peak Alcohol Use Index (QFP) frequency item

Time frame: 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)

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.

Daily Drinking Questionnaire (DDQ)

Time frame: 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)

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.

Rutgers Alcohol Problems Index

Time frame: 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)

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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.