Clinical trial NCT04254796: Neural Mechanisms of Meditation Training in Healthy and Depressed Adolescents: An MRI Connectome Study
Official title: Neural Mechanisms of Meditation Training in Healthy and Depressed Adolescents: An MRI Connectome Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institute of Mental Health (NIMH)
First posted: 2020-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Putamen Node Strength
timeFrame: Baseline/randomization and 12 weeks after baseline/randomization
Secondary outcomes:
measure: Change in Emotional Problems
timeFrame: Baseline/randomization and 12 weeks after baseline/randomization
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Olga Tymofiyeva, PhD
role: PRINCIPAL_INVESTIGATOR
References: