Substance UseNCT05537961
Impact of Mindfulness Training on Adolescent Well-Being and Behavior
A study testing Mindfulness-Oriented Recovery Enhancement in people with Substance Use and Mindfulness, run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 21 years
- Conditions the study is for
- Substance Use, Mindfulness, Psychological Well-being
- What is being tested?
- Mindfulness-Oriented Recovery Enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2022to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Enrolled as a high school senior in two specific classes at Judge Memorial High School during Spring 2022
Who cannot join
- Not enrolled as a high school senior in two specific classes at Judge Memorial High School during Spring 2022
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Substance Use, Mindfulness, Psychological Well-being
- Being tested
- Mindfulness-Oriented Recovery Enhancement
- Medical subject headings
- Substance-Related Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Oriented Recovery EnhancementBehavioural
Mindfulness instruction incorporated in classroom-based curriculum
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Weekly mindfulness instruction embedded in classroom setting Receives: Behavioral: Mindfulness-Oriented Recovery Enhancement |
| No Intervention | No intervention | Classroom setting completed as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: change in each measure across 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start13 Jan 2022
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Cambron, University of Utah
- Investigators
- Christopher Cambron, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537961
- Sponsor's protocol ID
- IRB_00122449
- Status last verified
- Sep 2023
- First submitted
- 18 Aug 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mindfulness Training on Adolescent Well-Being and Behavior
- ClinicalTrials.gov ID
- NCT05537961
- Acronym / sponsor ID
- IRB_00122449
- Conditions
- Substance Use, Mindfulness, Psychological Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindfulness-Oriented Recovery EnhancementWeekly mindfulness instruction embedded in classroom setting |
| No Intervention | No intervention | –Classroom setting completed as usual |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Enrolled as a high school senior in two specific classes at Judge Memorial High School during Spring 2022
Key exclusion criteria (1 listed)
- Not enrolled as a high school senior in two specific classes at Judge Memorial High School during Spring 2022
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Oriented Recovery EnhancementMindfulness instruction incorporated in classroom-based curriculum | Behavioural | Mindfulness |
Primary outcome
Youth Risk Behavior Surveillance System: Substance use
Time frame: change in each measure across 9 months
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.
Youth Risk Behavior Surveillance System: Suicide ideation
Time frame: change in each measure across 9 months
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.
Pediatric Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: change in each measure across 9 months
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.
Child Acceptance and Mindfulness Measure
Time frame: change in each measure across 9 months
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
Cognitive Emotion Regulation Questionnaire
Time frame: change in each measure across 9 months
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.
Nondual Awareness Dimensional Assessment
Time frame: change in each measure across 9 months
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
Toronto Mindfulness Scale
Time frame: change in each measure across 9 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Cambron, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Oriented Recovery Enhancement in people with Substance Use and Mindfulness, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Youth Risk Behavior Surveillance System: Substance use (time frame: change in each measure across 9 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.