Mindfulness Training for Vaping Teens

Overseen By Betty Jo Salmeron, M.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: National Institute on Drug Abuse (NIDA)

Must not be taking: Psychotropic medications

Disqualifiers: Chronic medical, Neurological, Neurodevelopmental, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this translational bench-to-bedside study is to examine the neurobiological effects of an evidence-based technology-delivered mindfulness training (MT) program on vaping-related rsFC alterations in hippocampal networks and testing whether changes in rsFC ((Delta)rsFC) in these networks predict reduction in tobacco vaping behaviors in adolescents. The study also aims to test the accessibility and feasibility of using this mindfulness-based stress reduction (MBSR) platform as an implementation for widespread MT in adolescents....

Will I have to stop taking my current medications?

The trial requires that if you are on medication for depression, anxiety, or ADHD, your dose must have been stable for the past 3 months. So, you won't need to stop taking your current medications, but you shouldn't change the dose either.

What data supports the effectiveness of the treatment Mindfulness-based Stress Reduction (MBSR) Program for vaping teens?

Mindfulness-based Stress Reduction (MBSR) has been shown to help reduce symptoms of stress, anxiety, and depression in various groups, which suggests it might also help teens who vape by addressing underlying stress or emotional issues. ^{1 2 3 4 5}

Is mindfulness training safe for humans?

Mindfulness-based stress reduction (MBSR) is generally considered safe for humans and has been used widely in medical settings for over 20 years to help with stress, anxiety, and other conditions. ^{1 3 4 5 6}

How is the Mindfulness-based Stress Reduction (MBSR) treatment different from other treatments for vaping teens?

The Mindfulness-based Stress Reduction (MBSR) treatment is unique because it uses mindfulness meditation to help manage stress and improve mental health, rather than relying on medication. This approach is non-pharmacological, meaning it doesn't involve drugs, and it has been shown to reduce symptoms of stress, anxiety, and depression in various populations. ^{1 4 5 7 8}

Research Team

Betty Jo Salmeron, M.D.

Principal Investigator

National Institute on Drug Abuse (NIDA)

Eligibility Criteria

This trial is for healthy teenagers who vape and are interested in trying a mindfulness-based stress reduction program to potentially reduce their vaping habits. Specific eligibility criteria details were not provided.

Inclusion Criteria

I am a teenager, aged 13-18, and currently in high school.

My parents or guardian have agreed to my participation if I'm 17 or under and not vaping.

Non-Vaping group: No DSM-5 diagnosis of moderate or severe SUD related to a psychoactive substance in the past year

Exclusion Criteria

I had a serious brain injury with either a loss of consciousness for over 30 minutes or lasting effects.

Chronic medical conditions associated with cerebral blood flow abnormalities per PI/MAI determination after review of medical history

Current regular meditation or yoga practice averaging >10 min/day for >2 days per week

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mindfulness-based Stress Reduction (MBSR) Training

Participants undergo in-person and technology-delivered mindfulness-based stress reduction training to study neurobehavioral correlates of nicotine vaping

5.5-7 months

Follow-up

Participants are monitored for changes in vaping behavior, emotion regulation, and engagement with a smoking cessation app after MBSR training

3 months

Treatment Details

Interventions

• Mindfulness-based Stress Reduction (MBSR) Program

Trial Overview The study tests how an online mindfulness training program affects brain connections related to memory and emotion (hippocampal networks) and if these changes can predict a decrease in tobacco vaping among teens.

Participant Groups

Group I: Mindfulness-based Stress Reduction (MBSR) Program Experimental Treatment 1 Intervention

This protocol will use fMRI and in-person and technology-delivered mindfulness-based stress reduction (MBSR) training to elucidate neurobehavioral correlates of regular nicotine vaping in adolescents compared to non-vaping adolescents, and changes in these correlates after MBSR training.

Who Is Running the Clinical Trial?

National Institute on Drug Abuse (NIDA)

Lead Sponsor

Trials

2,658

Recruited

3,409,000+

Findings from Research

Mindfulness-based stress reduction (MBSR) has been shown to improve mental health and reduce symptoms of stress, anxiety, and depression across 31 randomized studies involving both clinical and non-clinical populations.

The implementation of MBSR in the healthcare system is recommended to be gradual, ensuring that MBSR teachers in Denmark receive adequate training and education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. Fjorback, LO., Rasmussen, BH., Preuss, T.[2019]

The mindfulness-based stress reduction (MBSR) program significantly helped mental health professionals reduce their work stress and improve their self-care, which in turn enhanced patient care.

Participants in the MBSR program reported increased patient satisfaction and a reduction in patient safety events, indicating a positive impact on both staff well-being and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of mindfulness meditation in promoting a culture of safety on an acute psychiatric unit. Brady, S., O'Connor, N., Burgermeister, D., et al.[2012]

Mindfulness-Based Stress Reduction (MBSR) is a program designed to help individuals manage stress and emotions through mindfulness meditation, but current research shows significant methodological issues and a lack of robust evidence regarding its effectiveness.

While there is some preliminary evidence suggesting MBSR may be beneficial, the overall findings do not strongly support its widespread endorsement, indicating a need for more rigorous research to better understand its efficacy and mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do we really know about mindfulness-based stress reduction? Bishop, SR.[2022]

A systematic review of 18 studies found that Mindfulness Based Stress Reduction (MBSR) therapy significantly improves the conditions of patients with chronic illnesses such as cancer, hypertension, and diabetes.

MBSR offers a promising alternative treatment method that helps patients manage their diseases more effectively, although more research is needed to fully understand its mechanisms and potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. Niazi, AK., Niazi, SK.[2022]

An abbreviated Mindfulness-Based Stress Reduction (MBSR) program consisting of 6 weekly 75-minute sessions can effectively be implemented during staff lunch breaks, making it a practical training option for healthcare providers and clinic staff.

This adapted MBSR program is not only feasible but also well-accepted, suggesting it could enhance the well-being of healthcare workers in a workplace setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. Hazlett-Stevens, H.[2021]

The Journeys to Wellness trial successfully adapted the standard 8-week mindfulness-based stress reduction (MBSR) program into a workshop and teleconference format (tMBSR) for 63 kidney transplant candidates, showing high attendance and satisfaction rates among participants.

Participants in the tMBSR group reported significantly higher expectations of the intervention's usefulness for managing their health (83%) compared to the tSupport group (43%), indicating a positive reception and potential efficacy of the mindfulness training for improving quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-adapted mindfulness-based stress reduction (tMBSR) for patients awaiting kidney transplantation: Trial design, rationale and feasibility. Reilly-Spong, M., Reibel, D., Pearson, T., et al.[2022]

An eight-week study involving 63 participants compared the effects of Mindfulness Based Stress Reduction (MBSR) to an active control group (Health Enhancement Program) on sustained attention, but found no significant differences in improvement between the two groups.

While MBSR did not enhance sustained attention, there was some evidence of improved visual discrimination, suggesting that mindfulness training may have specific benefits, but further research is needed to clarify its effects on different aspects of attention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No sustained attention differences in a longitudinal randomized trial comparing mindfulness based stress reduction versus active control. MacCoon, DG., MacLean, KA., Davidson, RJ., et al.[2022]

In a study of 66 healthy adults, 8 weeks of aerobic exercise training (AET) significantly increased the time spent in moderate-to-vigorous physical activity (MVPA) compared to a no-treatment control, suggesting AET is effective for enhancing physical activity levels.

Mindfulness-based stress reduction (MBSR) training appeared to help mitigate the decrease in physical activity typically associated with shorter days and cooler weather, indicating its potential role in maintaining exercise participation during challenging seasonal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of 8-wk Mindfulness-based Stress Reduction or Aerobic Training on Seasonal Declines in Physical Activity. Meyer, JD., Torres, ER., Grabow, ML., et al.[2020]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The impact of mindfulness meditation in promoting a culture of safety on an acute psychiatric unit. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

What do we really know about mindfulness-based stress reduction? [2022]

4. India pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Telephone-adapted mindfulness-based stress reduction (tMBSR) for patients awaiting kidney transplantation: Trial design, rationale and feasibility. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

No sustained attention differences in a longitudinal randomized trial comparing mindfulness based stress reduction versus active control. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Benefits of 8-wk Mindfulness-based Stress Reduction or Aerobic Training on Seasonal Declines in Physical Activity. [2020]