Summary

Eligibility
for people ages 14-18 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
Olga Tymofiyeva, PhD (ucsf)
Photo of Olga Tymofiyeva
Olga Tymofiyeva

Description

Summary

The primary objective will be to study changes in putamen structural connectivity in healthy teens with meditation training. Hypothesis: Putamen structural node strength will increase in the training group compared to controls. R61 Go/No-Go Criteria. Detect an effect size (a threshold of Cohen's d > 0.20) in changes of the primary mechanistic outcome (Putamen structural node strength) by the described meditation training in 100 healthy adolescents that are 14-18 years old and retain at least 80% of randomized participants for primary outcome measurement at the end of the study regardless of adherence to the intervention. The secondary objective will be to study changes in emotional problems in healthy teens with meditation training. Hypothesis: There will be a significant decrease in emotional problems measured with the Strengths and Difficulties Questionnaire (SDQ) in the training group compared to controls. Design and Outcomes: The current research study design will utilize an individually randomized group treatment, open-label, waitlist-controlled clinical trial to test the efficacy and safety of the investigator's innovative mindfulness meditation intervention (Training for Awareness Resilience and Action [TARA]) on the primary outcome (Putamen structural node strength) and secondary outcome (emotional problems measured with the Strengths and Difficulties Questionnaire [SDQ]) in healthy adolescents between the ages of 14 to 18 years old.

Keywords

Healthy Meditation Healthy teens, MRI Depression Training for Awareness, Resilience, and Action (TARA) TARA Training

Eligibility

You can join if…

Open to people ages 14-18

  • Healthy female and male adolescents, 14-18 years old
  • Fluency in English

You CAN'T join if...

  • Subjects younger or older than 14-18 years old.
  • Subjects who are not healthy. Subjects who are taking any psychotropic medication.
  • MRI contraindications (ferromagnetic objects on or inside the body, e.g., braces) and pregnancy.
  • Not allowable: Current mindfulness training (e.g. MBSR, MBCT, DBT) and/or practice with a typically sitting meditation or yoga of 20 or more minutes two or more times per week within 60 days prior to study entry.
  • Potential adolescent subjects with current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to the study requirements will be excluded and not allowed to enter the study.
  • Potential subjects with an inability or unwillingness to give written informed assent or whose legal guardian/representative are unable or unwilling to give written informed consent will be excluded and not allowed to enter the study.

Location

  • UCSF accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UC Health

  • Olga Tymofiyeva, PhD (ucsf)
    Dr. Olga Tymofiyeva is an Assistant Professional Researcher in the UCSF Department of Radiology and Biomedical Imaging. Dr. Tymofiyeva holds her degrees in Physics (PhD, University of Wuerzburg, Germany), Electrical Engineering (MSc, University of Applied Sciences, Karlsruhe, Germany and BSc, NTUU “KPI”, Kyiv, Ukraine), and Psychology (BSc, University of Hagen, Germany).

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04254796
Study Type
Interventional
Last Updated