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Neural Mechanisms of Meditation Training in Healthy and Depressed Adolescents: An MRI Connectome Study

NCT04254796 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-06-26

Study results available
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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.

Conditions

  • Healthy

Interventions

BEHAVIORAL

Training for Awareness, Resilience, and Action (TARA)

This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)

Sponsors & Collaborators

Principal Investigators

  • Olga Tymofiyeva, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-19
Primary Completion
2021-12-20
Completion
2021-12-20

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04254796 on ClinicalTrials.gov