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Neural Mechanisms of Meditation Training in Healthy and Depressed Adolescents: An MRI Connectome Study PART 2

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: NCT05267340
Recruitment Status : Not yet recruiting
First Posted : March 4, 2022
Last Update Posted : March 4, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

The primary objective will be to study changes in putamen connectivity and depression severity in depressed teens with meditation training. H1: Putamen node strength will increase in the training group compared to the active controls. H2: This increase in node strength will correlate with practice amount recorded by participants. H3: There will be a significant reduction in self-rated depression symptoms following the training as measured by the Reynolds Adolescent Depression Scale (RADS-2), compared to controls. H4: This reduction will correlate with the increase in putamen node strength.

Design and Outcomes: The current research study design will utilize an individually randomized group treatment, open-label, active-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 (depression symptoms measured using Reynolds Adolescent Depression Scale [RADS-2]) in depressed adolescents between the ages of 14 to 18 years old.


Condition or disease Intervention/treatment Phase
Depression Mild Depression Moderate Depression, Teen Behavioral: TARA Behavioral: Psycho-Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Neural Mechanisms of Meditation Training in Healthy and Depressed Adolescents: An MRI Connectome Study PART 2
Estimated Study Start Date : August 2022
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)

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

Active Comparator: Control: Psycho-Education

Behavioral: Training for Awareness, Resilience, and Action (TARA) without the mindfulness meditation components

This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA) without the mindfulness meditation components

Behavioral: Psycho-Education
This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA) without the mindfulness meditation components




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 Depression Symptoms [ Time Frame: Baseline/randomization and 12 weeks after baseline/randomization ]
    Change in the score on the Reynold's Adolescent Depression Scale-2 (RADS-2). The RADS-2 has a possible range of 30 to 120. Higher scores represent higher levels of depression.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

The inclusion criteria: unmedicated adolescents with mild to moderate depression, of both sexes, 14-18 years old, with depression symptoms corresponding to RADS-2 t-scores of 61-69 (t-scores below 61 are the normal range, t-scores 70 and above are considered to be severe clinical depression), under the care of a primary care doctor.

Exclusion criteria are psychiatric comorbidities other than anxiety disorder, severe suicidal ideation, as well as MRI contraindications (ferromagnetic objects on or inside the body, e.g. braces) and pregnancy.


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): NCT05267340


Contacts
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Contact: Olga Tymofiyeva, PhD 4152835406 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
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05267340    
Other Study ID Numbers: 19-29083 (c)
First Posted: March 4, 2022    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: February 2022
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
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders