120 Participants Needed

Mindfulness Training for Vaping Teens

BJ
Overseen ByBetty Jo Salmeron, M.D.
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: National Institute on Drug Abuse (NIDA)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.13456

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.14578

Research Team

National Institute on Drug Abuse ...

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
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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
See 4 more

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
1Treatment groups
Experimental Treatment
Group I: Mindfulness-based Stress Reduction (MBSR) ProgramExperimental Treatment1 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.

Find a Clinic Near You

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

References

[Effect of mindfulness on symptoms of stress, anxiety and depression]. [2019]
The impact of mindfulness meditation in promoting a culture of safety on an acute psychiatric unit. [2012]
What do we really know about mindfulness-based stress reduction? [2022]
Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. [2022]
Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. [2021]
Telephone-adapted mindfulness-based stress reduction (tMBSR) for patients awaiting kidney transplantation: Trial design, rationale and feasibility. [2022]
No sustained attention differences in a longitudinal randomized trial comparing mindfulness based stress reduction versus active control. [2022]
Benefits of 8-wk Mindfulness-based Stress Reduction or Aerobic Training on Seasonal Declines in Physical Activity. [2020]
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