Trial Outcomes & Findings for Research Evaluating Sleep & Trends for Universal Prevention (NCT NCT04783519)
NCT ID: NCT04783519
Last Updated: 2024-06-07
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)
Results posted on
2024-06-07
Participant Flow
Participants (N=150, aged 18-24) were recruited in spring 2021 - spring 2022 via online advertising (e.g., Instagram/Facebook, Reddit, TikTok, Craigslist) and from young adults responding to advertising or invitations for other studies in the investigators' lab for which they did not meet criteria, who met initial screening criteria for the study and agreed to future contact. Participants recruited from either source completed additional screening and identity verification prior to enrollment.
Participant milestones
| Measure |
BASICS + SLEEP
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.
|
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, motives, and protective behavioral skills for reducing heavy episodic drinking and consequences. BASICS is delivered in a motivational interviewing (MI) style to enhance intrinsic motivation to change and implement protective behavioral strategies and has been adapted to target marijuana use. The BASICS condition will meet for 2 45-75 min. sessions. Content depends on 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 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.
|
Assessment Only Control
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
50
|
|
Overall Study
COMPLETED
|
38
|
37
|
41
|
|
Overall Study
NOT COMPLETED
|
11
|
14
|
9
|
Reasons for withdrawal
| Measure |
BASICS + SLEEP
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.
|
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, motives, and protective behavioral skills for reducing heavy episodic drinking and consequences. BASICS is delivered in a motivational interviewing (MI) style to enhance intrinsic motivation to change and implement protective behavioral strategies and has been adapted to target marijuana use. The BASICS condition will meet for 2 45-75 min. sessions. Content depends on 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 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.
|
Assessment Only Control
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
7
|
3
|
|
Overall Study
Lost to Follow-up
|
9
|
7
|
6
|
Baseline Characteristics
Research Evaluating Sleep & Trends for Universal Prevention
Baseline characteristics by cohort
| Measure |
BASICS + SLEEP
n=49 Participants
The BASICS + SLEEP intervention integrated BASICS feedback and Motivational Interviewing (MI) for alcohol and marijuana use as described in the BASICS arm with Brief Behavioral Therapy for Insomnia (BBTI). The BASICS + SLEEP intervention was implemented in 2 telehealth sessions of 45-75 minutes and 2 telehealth booster sessions (20-30 mins). Sessions provided rationale for insomnia and importance of behavioral strategies to regulate sleep; introduction of sleep hygiene; discussion of factors (including alcohol and cannabis use) that impede duration and quality of sleep; introduction of sleep restriction and stimulus control strategies and negotiation of an initial sleep restriction schedule and alcohol/cannabis goals; 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 intervention included personalized feedback depicting both alcohol and cannabis use and perceived norms as well as insomnia symptoms. Feedback also addressed personal maintaining factors for insomnia, sleep hygiene factors, and protective behavioral strategies for both alcohol and cannabis use.
|
BASICS
n=51 Participants
The BASICS condition was conducted via telehealth for 2 sessions of 45-75 minutes and 2 telehealth booster sessions (20-30 minutes). 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. Both alcohol and cannabis content were integrated in this condition but without specific content to address insomnia symptoms.
|
Assessment Only Control
n=50 Participants
Participants in Assessment Only Control (AOC) condition completed all assessments (including survey, daily, actigraphy) at the same time as participants in the 2 active interventions. AOC also attended an in-person meeting to verify identity, provide rationale for daily monitoring, control for time/attention, and participants in all conditions including AOC received referrals for community services to address alcohol and MJ use, sleep, and other mental health concerns. No participants were deprived of services. AOC condition was offered BASICS + SLEEP after the 3-month follow-up.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
21.37 years
STANDARD_DEVIATION 1.68 • n=5 Participants
|
21.16 years
STANDARD_DEVIATION 1.78 • n=7 Participants
|
20.74 years
STANDARD_DEVIATION 1.60 • n=5 Participants
|
21.09 years
STANDARD_DEVIATION 1.70 • n=4 Participants
|
|
Sex/Gender, Customized
Men
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Women
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Non-binary/Gender Diverse
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
51 participants
n=7 Participants
|
50 participants
n=5 Participants
|
150 participants
n=4 Participants
|
|
Insomnia Severity Index (ISI)
|
15.04 Score on a scale
STANDARD_DEVIATION 3.78 • n=5 Participants
|
15.22 Score on a scale
STANDARD_DEVIATION 3.55 • n=7 Participants
|
15.20 Score on a scale
STANDARD_DEVIATION 3.53 • n=5 Participants
|
15.15 Score on a scale
STANDARD_DEVIATION 3.59 • n=4 Participants
|
|
Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a
|
63.72 T-Score
STANDARD_DEVIATION 5.66 • n=5 Participants
|
63.70 T-Score
STANDARD_DEVIATION 5.30 • n=7 Participants
|
63.76 T-Score
STANDARD_DEVIATION 6.76 • n=5 Participants
|
63.73 T-Score
STANDARD_DEVIATION 5.89 • n=4 Participants
|
|
Quantity/Frequency/Peak Alcohol Use Index (QFP) peak item
|
7.80 Peak number of standard drinks
STANDARD_DEVIATION 3.03 • n=5 Participants
|
7.69 Peak number of standard drinks
STANDARD_DEVIATION 2.89 • n=7 Participants
|
8.18 Peak number of standard drinks
STANDARD_DEVIATION 4.21 • n=5 Participants
|
7.89 Peak number of standard drinks
STANDARD_DEVIATION 3.41 • n=4 Participants
|
|
Quantity/Frequency/Peak Alcohol Use Index (QFP) quantity item
|
3.53 Standard drinks per occasion
STANDARD_DEVIATION 1.46 • n=5 Participants
|
4.12 Standard drinks per occasion
STANDARD_DEVIATION 2.96 • n=7 Participants
|
4.16 Standard drinks per occasion
STANDARD_DEVIATION 2.71 • n=5 Participants
|
3.94 Standard drinks per occasion
STANDARD_DEVIATION 2.47 • n=4 Participants
|
|
Quantity/Frequency/Peak Alcohol Use Index (QFP) frequency item
|
14.16 Days per week
STANDARD_DEVIATION 5.94 • n=5 Participants
|
13.62 Days per week
STANDARD_DEVIATION 5.88 • n=7 Participants
|
13.73 Days per week
STANDARD_DEVIATION 7.12 • n=5 Participants
|
13.84 Days per week
STANDARD_DEVIATION 6.27 • n=4 Participants
|
|
Daily Drinking Questionnaire (DDQ)
|
10.18 Standard drinks per week
STANDARD_DEVIATION 7.41 • n=5 Participants
|
11.29 Standard drinks per week
STANDARD_DEVIATION 8.41 • n=7 Participants
|
13.5 Standard drinks per week
STANDARD_DEVIATION 14.25 • n=5 Participants
|
11.67 Standard drinks per week
STANDARD_DEVIATION 10.49 • n=4 Participants
|
|
Rutgers Alcohol Problems Index
|
10.82 Score on a scale
STANDARD_DEVIATION 9.09 • n=5 Participants
|
12.33 Score on a scale
STANDARD_DEVIATION 14.94 • n=7 Participants
|
8.88 Score on a scale
STANDARD_DEVIATION 11.45 • n=5 Participants
|
10.69 Score on a scale
STANDARD_DEVIATION 12.11 • n=4 Participants
|
|
Daily Marijuana Questionnaire
|
16.06 Hours high per week
STANDARD_DEVIATION 17.95 • n=5 Participants
|
16.47 Hours high per week
STANDARD_DEVIATION 16.74 • n=7 Participants
|
15.26 Hours high per week
STANDARD_DEVIATION 19.22 • n=5 Participants
|
15.93 Hours high per week
STANDARD_DEVIATION 17.87 • n=4 Participants
|
|
Marijuana-Related Consequences
|
31.57 Score on a scale
STANDARD_DEVIATION 18.88 • n=5 Participants
|
32.78 Score on a scale
STANDARD_DEVIATION 20.71 • n=7 Participants
|
30.80 Score on a scale
STANDARD_DEVIATION 15.75 • n=5 Participants
|
31.73 Score on a scale
STANDARD_DEVIATION 18.47 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
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).
Outcome measures
| Measure |
BASICS + SLEEP
n=40 Participants
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.
|
BASICS
n=36 Participants
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, motives, and protective behavioral skills for reducing heavy episodic drinking and consequences. BASICS is delivered in a motivational interviewing (MI) style to enhance intrinsic motivation to change and implement protective behavioral strategies and has been adapted to target marijuana use. The BASICS condition will meet for 2 45-75 min. sessions. Content depends on 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 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.
|
Assessment Only Control
n=41 Participants
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.
|
|---|---|---|---|
|
Insomnia Severity Index (ISI)
Post Assessment
|
8.48 Score on a scale
Standard Deviation 4.73
|
9.69 Score on a scale
Standard Deviation 3.24
|
11.31 Score on a scale
Standard Deviation 3.38
|
|
Insomnia Severity Index (ISI)
3 Month Follow-up
|
7.14 Score on a scale
Standard Deviation 4.61
|
8.97 Score on a scale
Standard Deviation 5.55
|
9.71 Score on a scale
Standard Deviation 4.00
|
PRIMARY outcome
Timeframe: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
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.
Outcome measures
| Measure |
BASICS + SLEEP
n=40 Participants
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.
|
BASICS
n=36 Participants
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, motives, and protective behavioral skills for reducing heavy episodic drinking and consequences. BASICS is delivered in a motivational interviewing (MI) style to enhance intrinsic motivation to change and implement protective behavioral strategies and has been adapted to target marijuana use. The BASICS condition will meet for 2 45-75 min. sessions. Content depends on 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 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.
|
Assessment Only Control
n=41 Participants
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.
|
|---|---|---|---|
|
Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI)
Post Assessment
|
54.06 T-Score
Standard Deviation 7.85
|
57.31 T-Score
Standard Deviation 6.97
|
58.72 T-Score
Standard Deviation 6.38
|
|
Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI)
3 Month Follow-up
|
52.66 T-Score
Standard Deviation 7.93
|
56.57 T-Score
Standard Deviation 7.27
|
57.11 T-Score
Standard Deviation 7.71
|
PRIMARY outcome
Timeframe: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
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.
Outcome measures
| Measure |
BASICS + SLEEP
n=40 Participants
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.
|
BASICS
n=36 Participants
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, motives, and protective behavioral skills for reducing heavy episodic drinking and consequences. BASICS is delivered in a motivational interviewing (MI) style to enhance intrinsic motivation to change and implement protective behavioral strategies and has been adapted to target marijuana use. The BASICS condition will meet for 2 45-75 min. sessions. Content depends on 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 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.
|
Assessment Only Control
n=41 Participants
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.
|
|---|---|---|---|
|
Quantity/Frequency/Peak Alcohol Use Index (QFP) Peak Item
Post Assessment
|
6.45 Peak number of standard drinks
Standard Deviation 3.15
|
5.92 Peak number of standard drinks
Standard Deviation 2.86
|
8.18 Peak number of standard drinks
Standard Deviation 4.77
|
|
Quantity/Frequency/Peak Alcohol Use Index (QFP) Peak Item
3 Month Follow-up
|
5.06 Peak number of standard drinks
Standard Deviation 2.94
|
4.44 Peak number of standard drinks
Standard Deviation 2.71
|
7.24 Peak number of standard drinks
Standard Deviation 5.08
|
PRIMARY outcome
Timeframe: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
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.
Outcome measures
| Measure |
BASICS + SLEEP
n=40 Participants
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.
|
BASICS
n=36 Participants
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, motives, and protective behavioral skills for reducing heavy episodic drinking and consequences. BASICS is delivered in a motivational interviewing (MI) style to enhance intrinsic motivation to change and implement protective behavioral strategies and has been adapted to target marijuana use. The BASICS condition will meet for 2 45-75 min. sessions. Content depends on 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 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.
|
Assessment Only Control
n=41 Participants
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.
|
|---|---|---|---|
|
Quantity/Frequency/Peak Alcohol Use Index (QFP) Quantity Item
Post Assessment
|
2.93 Drinks per occasion
Standard Deviation 1.75
|
2.58 Drinks per occasion
Standard Deviation 1.61
|
3.36 Drinks per occasion
Standard Deviation 2.05
|
|
Quantity/Frequency/Peak Alcohol Use Index (QFP) Quantity Item
3 Month Follow-up
|
2.63 Drinks per occasion
Standard Deviation 1.48
|
2.41 Drinks per occasion
Standard Deviation 1.79
|
3.61 Drinks per occasion
Standard Deviation 2.61
|
PRIMARY outcome
Timeframe: Baseline, 3 Month Follow-up (3 months post-Baseline)Population: Analyses are using 3 Month Follow-up data.
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.
Outcome measures
| Measure |
BASICS + SLEEP
n=35 Participants
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.
|
BASICS
n=34 Participants
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, motives, and protective behavioral skills for reducing heavy episodic drinking and consequences. BASICS is delivered in a motivational interviewing (MI) style to enhance intrinsic motivation to change and implement protective behavioral strategies and has been adapted to target marijuana use. The BASICS condition will meet for 2 45-75 min. sessions. Content depends on 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 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.
|
Assessment Only Control
n=41 Participants
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.
|
|---|---|---|---|
|
Quantity/Frequency/Peak Alcohol Use Index (QFP) Frequency Item
|
8.49 Days per week
Standard Deviation 6.75
|
6.79 Days per week
Standard Deviation 4.97
|
9.66 Days per week
Standard Deviation 6.19
|
PRIMARY outcome
Timeframe: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
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.
Outcome measures
| Measure |
BASICS + SLEEP
n=40 Participants
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.
|
BASICS
n=36 Participants
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, motives, and protective behavioral skills for reducing heavy episodic drinking and consequences. BASICS is delivered in a motivational interviewing (MI) style to enhance intrinsic motivation to change and implement protective behavioral strategies and has been adapted to target marijuana use. The BASICS condition will meet for 2 45-75 min. sessions. Content depends on 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 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.
|
Assessment Only Control
n=41 Participants
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.
|
|---|---|---|---|
|
Daily Drinking Questionnaire (DDQ)
Post Assessment
|
6.43 Standard drinks per week
Standard Deviation 6.77
|
6.50 Standard drinks per week
Standard Deviation 6.67
|
11.05 Standard drinks per week
Standard Deviation 9.81
|
|
Daily Drinking Questionnaire (DDQ)
3 Month Follow-up
|
6.09 Standard drinks per week
Standard Deviation 6.12
|
4.48 Standard drinks per week
Standard Deviation 4.24
|
10.63 Standard drinks per week
Standard Deviation 9.86
|
PRIMARY outcome
Timeframe: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
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.
Outcome measures
| Measure |
BASICS + SLEEP
n=40 Participants
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.
|
BASICS
n=36 Participants
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, motives, and protective behavioral skills for reducing heavy episodic drinking and consequences. BASICS is delivered in a motivational interviewing (MI) style to enhance intrinsic motivation to change and implement protective behavioral strategies and has been adapted to target marijuana use. The BASICS condition will meet for 2 45-75 min. sessions. Content depends on 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 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.
|
Assessment Only Control
n=41 Participants
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.
|
|---|---|---|---|
|
Rutgers Alcohol Problems Index
Post Assessment
|
6.85 Score on a scale
Standard Deviation 9.41
|
5.25 Score on a scale
Standard Deviation 6.71
|
7.64 Score on a scale
Standard Deviation 6.10
|
|
Rutgers Alcohol Problems Index
3 Month Follow-up
|
5.57 Score on a scale
Standard Deviation 7.05
|
5.27 Score on a scale
Standard Deviation 9.10
|
6.85 Score on a scale
Standard Deviation 6.52
|
SECONDARY outcome
Timeframe: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
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.
Outcome measures
| Measure |
BASICS + SLEEP
n=39 Participants
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.
|
BASICS
n=32 Participants
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, motives, and protective behavioral skills for reducing heavy episodic drinking and consequences. BASICS is delivered in a motivational interviewing (MI) style to enhance intrinsic motivation to change and implement protective behavioral strategies and has been adapted to target marijuana use. The BASICS condition will meet for 2 45-75 min. sessions. Content depends on 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 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.
|
Assessment Only Control
n=40 Participants
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.
|
|---|---|---|---|
|
Daily Marijuana Questionnaire
Post Assessment
|
7.95 Hours high per week
Standard Deviation 9.56
|
8.34 Hours high per week
Standard Deviation 8.80
|
11.21 Hours high per week
Standard Deviation 19.24
|
|
Daily Marijuana Questionnaire
3 Month Follow-up
|
9.18 Hours high per week
Standard Deviation 11.89
|
8.26 Hours high per week
Standard Deviation 11.99
|
11.6 Hours high per week
Standard Deviation 18.75
|
SECONDARY outcome
Timeframe: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
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.
Outcome measures
| Measure |
BASICS + SLEEP
n=40 Participants
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.
|
BASICS
n=36 Participants
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, motives, and protective behavioral skills for reducing heavy episodic drinking and consequences. BASICS is delivered in a motivational interviewing (MI) style to enhance intrinsic motivation to change and implement protective behavioral strategies and has been adapted to target marijuana use. The BASICS condition will meet for 2 45-75 min. sessions. Content depends on 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 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.
|
Assessment Only Control
n=41 Participants
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.
|
|---|---|---|---|
|
Marijuana-Related Consequences
Post Assessment
|
16.10 Score on a scale
Standard Deviation 15.86
|
14.97 Score on a scale
Standard Deviation 14.91
|
18.59 Score on a scale
Standard Deviation 13.78
|
|
Marijuana-Related Consequences
3 Month Follow-up
|
19.71 Score on a scale
Standard Deviation 15.02
|
18.24 Score on a scale
Standard Deviation 17.19
|
23.17 Score on a scale
Standard Deviation 12.69
|
Adverse Events
BASICS + SLEEP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BASICS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Assessment Only Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place