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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-19

Study Completion Date

2021-12-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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TARA Training

12-week group TARA Training

Group Type EXPERIMENTAL

Training for Awareness, Resilience, and Action (TARA)

Intervention Type BEHAVIORAL

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

Control

Waitlist Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Training for Awareness, Resilience, and Action (TARA)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes