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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04254796
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.


Condition or disease Intervention/treatment Phase
Healthy Behavioral: Training for Awareness, Resilience, and Action (TARA) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Neural Mechanisms of Meditation Training in Healthy and Depressed Adolescents: An MRI Connectome Study
Actual Study Start Date : June 19, 2020
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TARA Training Behavioral: Training for Awareness, Resilience, and Action (TARA)
This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)
No Intervention: Control


Outcome Measures
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Primary Outcome Measures :
  1. Change in Putamen node strength [ Time Frame: Baseline/randomization and 12 weeks after baseline/randomization ]
    Change in the Putamen node strength assessed using diffusion MRI


Secondary Outcome Measures :
  1. Change in Emotional Problems [ Time Frame: Baseline/randomization and 12 weeks after baseline/randomization ]
    Change in the level of emotional problems measured with the Strengths and Difficulties Questionnaire (SDQ). The emotional problems scores have a possible range of 0 to 10. Higher scores represent higher levels of emotional problems.


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04254796


Contacts
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Contact: Benjamin Sipes, MSc 415-514-6759 benjamin.sipes@ucsf.edu
Contact: Namasvi Jariwala, MA 415-514-6759 namasvi.jariwala@ucsf.edu

Locations
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United States, California
UCSF Recruiting
San Francisco, California, United States, 94143
Contact: Olga Tymofiyeva, PhD       olga.tymofiyeva@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Olga Tymofiyeva, PhD University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04254796    
Other Study ID Numbers: 19-29083
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms