An interventional study of Mindfulness-Oriented Recovery Enhancement in Substance Use, Mindfulness and Psychological Well-being, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 15 Years to 21 Years. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by University of Utah · Not applicable, Interventional, and Prevention
There is a broad consensus that preventing or delaying initiation of adolescent alcohol, tobacco, and other drug (ATOD) use can substantially improve both short- and long-term adolescent health. Despite the existence of effective prevention programs, adolescent ATOD use continues to be a substantial issue. Continued research on preventive interventions is needed. School-based mindfulness-based interventions (MBIs) have been shown to be feasible and effective at improving adolescent psychological well-being. Evidence from both quasi-experimental studies and randomized controlled trials suggests that incorporating MBIs into school-settings can lower levels of anxiety, depression, and stress, while improving capacity for emotional regulation. Greater mindfulness also been linked to reduced adolescent ATOD use via observational studies. There are strong theoretical reasons to believe that MBIs delivered in school settings can prevent or reduce ATOD use among youth. In particular, MBIs have been shown to improve psychological well-being among youth via multiple mechanisms also relevant for adolescent ATOD use. These mechanisms include enhanced attentional control, negative emotion regulation, promotion of positive emotion generation, and increased feelings of connectedness. Despite these connections, school-based MBIs are yet to demonstrate the ability to prevent or reduce adolescent ATOD use.
The current study will examine psychological well-being and ATOD use among approximately 80 participants in a quasi-experimental, school-based MBI. In early 2022, approximately 40 high school seniors were provided with one semester of a weekly, classroom-based MBI embedded into their Social Studies curriculum; approximately 40 high school seniors participated in the standard curriculum. The intervention group was provided with an adaptation of Mindfulness-Oriented Recovery Enhancement (MORE). MORE is an evidence-based therapeutic program that integrates mindfulness, cognitive-behavioral therapy, and positive psychology to treat addiction and enhance well-being. MORE has been shown to produce therapeutic benefits in the treatment of alcohol, tobacco, and other drug addiction in adult populations, but is yet to be tested as a preventive intervention for youth. Follow up data collection is planned for spring 2023 to assess psychological well-being, ATOD use, and proposed therapeutic mechanisms pre-intervention, post-intervention, and at 9-month follow up.
There is a broad consensus that preventing or delaying initiation of adolescent alcohol, tobacco, and other drug (ATOD) use can substantially improve both short- and long-term adolescent health. Despite the existence of effective prevention programs, adolescent ATOD use continues to be a substantial issue. Continued research on preventive interventions is needed. School-based mindfulness-based interventions (MBIs) have been shown to be feasible and effective at improving adolescent psychological well-being. Evidence from both quasi-experimental studies and randomized controlled trials suggests that incorporating MBIs into school-settings can lower levels of anxiety, depression, and stress, while improving capacity for emotional regulation. Greater mindfulness also been linked to reduced adolescent ATOD use via observational studies. There are strong theoretical reasons to believe that MBIs delivered in school settings can prevent or reduce ATOD use among youth. In particular, MBIs have been shown to improve psychological well-being among youth via multiple mechanisms also relevant for adolescent ATOD use. These mechanisms include enhanced attentional control, negative emotion regulation, promotion of positive emotion generation, and increased feelings of connectedness. Despite these connections, school-based MBIs are yet to demonstrate the ability to prevent or reduce adolescent ATOD use.
The current study will examine psychological well-being and ATOD use among approximately 80 participants in a quasi-experimental, school-based MBI. In early 2022, approximately 40 high school seniors were provided with one semester of a weekly, classroom-based MBI embedded into their Social Studies curriculum; approximately 40 high school seniors participated in the standard curriculum. The intervention group was provided with an adaptation of Mindfulness-Oriented Recovery Enhancement (MORE). MORE is an evidence-based therapeutic program that integrates mindfulness, cognitive-behavioral therapy, and positive psychology to treat addiction and enhance well-being. MORE has been shown to produce therapeutic benefits in the treatment of alcohol, tobacco, and other drug addiction in adult populations, but is yet to be tested as a preventive intervention for youth. Follow up data collection is planned for spring 2023 to assess psychological well-being, ATOD use, and proposed therapeutic mechanisms pre-intervention, post-intervention, and at 9-month follow up. Trajectories of change will be assessed to test the following three aims.
Aim 1 is to examine the impact of MORE on changes in students' psychological well-being (i.e., anxiety, depression, stress) and ATOD use relative to a standard curriculum. The investigators hypothesize that MORE will improve psychological well-being and reduce ATOD use, relative to the standard curriculum.
Aim 2 is to examine the impact of MORE on changes in students' attentional control (i.e., mindfulness), negative emotion regulation (i.e., positive reappraisal), positive emotion generation (i.e., savoring), and feelings of connectedness (i.e., self-transcendence) relative to a standard curriculum. The investigators hypothesize that MORE will improve attentional control, negative emotion regulation, and positive emotion generation, as well as increasing feelings of connectedness, relative to a standard curriculum.
Aim 3 is to examine the extent to which MORE encourages improved psychological well-being and reduced ATOD use via the therapeutic mechanisms identified in Aim 2 (attentional control, negative emotion regulation, positive emotion generation, and feelings of connectedness). The investigators hypothesize that the relationship between MORE and positive outcomes will be mediated by the proposed therapeutic mechanisms.
Hypothesis: Results of the current study will provide important information to advance the fields of both ATOD prevention and school-based MBIs. Additionally, results of this study will be of wide interest to school administrators, school counselors, and clinicians working to prevent adolescent substance use. Successful completion of this study will lead to multiple publications. Additionally, results of this study will provide essential pilot data to inform further testing of MORE for adolescents via randomized controlled trials and support multiple possible grant submissions. While MBIs have become a common part of substance abuse treatment among adults, school-based MBIs for ATOD prevention lack sufficient evidence and are yet to be regularly incorporated into standard prevention efforts.
2,181 studies on the registry are indexed under Substance-Related Disorders; 399 are open to participants now.
This study's enrollment of 80 is below the median of 108 across 1,770 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University of Utah is the lead sponsor of 991 studies on the registry; 177 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 64 (58%) have results posted.
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Exclusion Criteria:
Weekly mindfulness instruction embedded in classroom setting
Behavioral: Mindfulness-Oriented Recovery Enhancement
Classroom setting completed as usual
Mindfulness instruction incorporated in classroom-based curriculum
Youth Risk Behavior Surveillance System: Substance use
alcohol, tobacco, and other drug use as measured by the Youth Risk Behavior Surveillance System. Items are measured as any use on both lifetime and past 30 days.
Time frame: change in each measure across 9 months
Youth Risk Behavior Surveillance System: Suicide ideation
suicide ideation and attempts as measured by the Youth Risk Behavior Surveillance System. Suicide ideation is measured as any ideation in the past 12 months and attempts are measured as the count of attempts in the past 12 months.
Time frame: change in each measure across 9 months
Pediatric Patient Reported Outcomes Measurement Information System (PROMIS)
positive affect, life satisfaction, meaning and purpose, anxiety, depressive symptoms as measured by the pediatric PROMIS. For each scale, higher scores indicate higher levels of the name of the scale. Items on each scale are summed and T scores with a mean of 50 and standard deviation of 10 are calculated.
Time frame: change in each measure across 9 months
Child Acceptance and Mindfulness Measure
Mindfulness as measured by the child acceptance and mindfulness measure (CAMM). The CAMM is scored from 0 to 40 with higher scores indicating higher levels of mindfulness
Time frame: change in each measure across 9 months
Cognitive Emotion Regulation Questionnaire
Positive reappraisal as measured by the Cognitive Emotion Regulation Questionnaire (CERQ). The CERQ is scored from 1 to 7 with higher scores indicating higher levels of emotion regulation.
Time frame: change in each measure across 9 months
Nondual Awareness Dimensional Assessment
Transcendental experiences as measured by the Nondual Awareness Dimensional Assessment (NADA). Higher scores indicate greater nondual awareness trait scored from 0 to 12 and nondual awareness states scores from 0 to 40
Time frame: change in each measure across 9 months
Toronto Mindfulness Scale
Mindfulness as measured by the Toronto Mindfulness Scale. Higher scores indicate higher degree of state mindfulness. Scores range from 0 to 24 on the curiosity subscale and from 0 to 28 on the decentering subscale.
Time frame: change in each measure across 9 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2022 to primary completion in May 2023, 16 months.
Of 812 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 16 months is below that.
Counting every sponsor, half of 855 studies reached it within 32 months; a quarter within 16 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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