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

NCT04254796 | Completed Results DMC

• 3 other identifiers: 19-290835R25MH0604821R61AT009864-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change in Putamen Node Strength

  Change in the Putamen node strength assessed using diffusion MRI. Node strengths are calculated as the sum of connection weights between the brain region of interest and all other nodes in the network. Higher values of node strength in general indicate stronger white matter connectivity between a specific brain region and the other regions, often caused by higher myelination. Higher values of change in node strength, similarly, indicate a higher level of structural network change occurred within the tissue.

  Baseline/randomization and 12 weeks after baseline/randomization

Secondary Outcomes (1)

• Change in Emotional Problems

  Baseline/randomization and 12 weeks after baseline/randomization

Study Arms (2)

TARA Training

EXPERIMENTAL

12-week group TARA Training

Behavioral: Training for Awareness, Resilience, and Action (TARA)

Control

NO INTERVENTION

Waitlist Control

Interventions

Training for Awareness, Resilience, and Action (TARA) BEHAVIORAL

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

TARA Training

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UCSF

San Francisco, California, 94143, United States

Location

Related Publications (1)

• Tymofiyeva O, Sipes BS, Luks T, Hamlat EJ, Samson TE, Hoffmann TJ, Glidden DV, Jakary A, Li Y, Ngan T, Henje E, Yang TT. Interoceptive brain network mechanisms of mindfulness-based training in healthy adolescents. Front Psychol. 2024 Aug 13;15:1410319. doi: 10.3389/fpsyg.2024.1410319. eCollection 2024.

  PMID: 39193038 DERIVED

Results Point of Contact

• Title: Olga Tymofiyeva
• Organization: University of California, San Francisco

olga.tymofiyeva@ucsf.edu

415-514-4870

Study Officials

• Olga Tymofiyeva, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: June 19, 2020
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: June 26, 2023
• Results First Posted: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)