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
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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|
|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|
- 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
- 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.
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
|Contact: Benjamin Sipes, MScemail@example.com|
|Contact: Namasvi Jariwala, MAfirstname.lastname@example.org|
|United States, California|
|San Francisco, California, United States, 94143|
|Contact: Olga Tymofiyeva, PhD email@example.com|
|Principal Investigator:||Olga Tymofiyeva, PhD||University of California, San Francisco|