Neural Mechanisms of Meditation Training in Healthy and Depressed Adolescents: An MRI Connectome Study
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
Primary Outcome Measures
- Change in Putamen node strength [Baseline/randomization and 12 weeks after baseline/randomization]
Change in the Putamen node strength assessed using diffusion MRI
Secondary Outcome Measures
- Change in Emotional Problems [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
Criteria
Inclusion Criteria:
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Healthy female and male adolescents, 14-18 years old
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Fluency in English
Exclusion Criteria:
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Subjects younger or older than 14-18 years old.
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Subjects who are not healthy. Subjects who are taking any psychotropic medication.
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MRI contraindications (ferromagnetic objects on or inside the body, e.g., braces) and pregnancy.
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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.
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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.
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCSF | San Francisco | California | United States | 94143 |
Sponsors and Collaborators
- University of California, San Francisco
Investigators
- Principal Investigator: Olga Tymofiyeva, PhD, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-29083