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Depression MildNCT05267340

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

A study testing TARA and Psycho-Education in people with Depression Mild and Depression Moderate, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 18 years
What is being tested?
TARA and Psycho-Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
8 Feb 2023to 15 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Female and male adolescents with elevated depression (RADS-2 T-score >50 or as judged by the study physician), 14-18 years old.
  • We will use Medical History form a (NCCIH Version 1.0). The required current status of participants within 4 weeks prior to randomization is absence of current medical, neurological, or psychiatric conditions except for a diagnosis of a DSM-5 depressive disorder (which is allowed but not required). Due to the exceptionally high comorbidity with depression and anxiety, participants with a depressive disorder and comorbid anxiety disorder will also be allowed to enter the study.
  • Fluency in English. Being under the care of a primary care provider or a mental health provider. Access to a smartphone, a tablet or a computer, on which program "Zoom" can be run for remote participation in the intervention.

Who cannot join

  • Subjects younger or older than 14-18 years old. Subjects who have a significant medical disorder or mental health disorder other than a DSM-5 depressive disorder or a depressive disorder with a comorbid anxiety disorder. We will use Phone Pre-Screener and Medical History form a (NCCIH Version 1.0) to exclude any adolescent who has been clinically diagnosed with any significant medical disorder that would prevent him or her from performing yoga-based movements (e.g., cerebral palsy), neurological disorder (e.g., multiple sclerosis, severe head trauma) or mental health disorder other than a DSM-5 depressive disorder or a DSM-5 depressive disorder and comorbid anxiety disorder (e.g., psychosis, schizophrenia, schizoaffective disorder, bipolar disorder, ADHD, autism spectrum disorder, anorexia nervosa, PTSD) or has intellectual disability, or suicidal ideation or attempt in past 3 months. (Please note that a diagnosis of a DSM-5 depressive disorder is allowed, but not required, to enter our study).
  • Subjects who are taking any psychotropic medication other than one of the first-line selective serotonin reuptake inhibitor (SSRI) antidepressant medications (i.e., fluoxetine, escitalopram, sertraline).
  • MRI contraindications (metallic objects on or inside the body, e.g., braces), some types of tatoos, and pregnancy.
  • Pregnancy or any plans to become pregnant during the study is an exclusion criterion for entrance into the study. Women of reproductive capability will be asked to employ at least one of the following allowable contraception methods until they complete their second MRI scan: birth control implant, birth control shot, birth control patch, birth control pill, condom, internal condom, birth control sponge, cervical cap, spermicide, fertility awareness (calendar method), outercourse and abstinence.
  • The study's pregnancy-related policy and procedure are as follows. First, all female participants will be asked to fill out a pregnancy screening questionnaire and then take a urine pregnancy test immediately prior to entering the MRI scanner room. Any subject that is either pregnant or might possibly be pregnant are not allowed to enter the MRI scanner room. Results of the urine pregnancy screening test will be shared with the adolescent subject only and not with the adolescent's parents or legal guardians. As per California state confidentiality laws, the results of pregnancy tests in minors cannot be shared with the minor's parent or legal guardian without the written permission of the minor. If the pregnancy test is positive, we will counsel the teen and give her referrals to teen pregnancy resources such as Planned Parenthood. If the participant is pregnant, the participant is not allowed to enter the study until the pregnancy is over. Second, if the participant who is in the intervention group becomes pregnant during the course of the study after the first MRI scan, she will be allowed to finish participating in the group intervention since there are no known potential adverse effects on the fetus due to meditation. However, although there are no known adverse negative effects of MRI scans on the fetus, we have decided to be conservative in our study and not allow participants who become pregnant during the study after the first MRI scan to have the second MRI scan in order to minimize any potential risk to the unborn fetus.
  • 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. We will use the Brief Screener for Tobacco, Alcohol, and other Drugs (BSTAD) developed by National Institute on Drug Abuse (NIDA) to determine higher risk subjects who will be excluded: https://www.drugabuse.gov/adolescent-substance-use-screening-tools.
  • 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.
  • Any other factors preventing from participation according to the judgment of the Principal Investigators.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UCSF

    San Francisco, California, 94143

Other trials in United States

About this study

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.

Being tested
TARA, Psycho-Education
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TARABehavioural

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

  • Psycho-EducationBehavioural

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

Study groups in NCT05267340
Study groupRoleWhat they receive
Experimental: TARA TrainingExperimentalBehavioral: Training for Awareness, Resilience, and Action (TARA) This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)
Receives: Behavioral: TARA
Control: Psycho-EducationActive comparatorBehavioral: 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
Receives: Behavioral: Psycho-Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Putamen node strength

    Change in the Putamen node strength assessed using diffusion MRI

    Measured: Baseline/randomization and 12 weeks after baseline/randomization

Secondary outcomes (1)
  1. Change in Depression Symptoms

    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.

    Measured: Baseline/randomization and 12 weeks after baseline/randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2022
  2. Study start8 Feb 2023
  3. Primary completion11 Dec 2025
  4. Study completion15 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05267340
Sponsor's protocol ID
19-29083 (c)
Other IDs
R33AT009864
Status last verified
Aug 2026
First submitted
23 Feb 2022
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TARA and Psycho-Education in people with Depression Mild and Depression Moderate, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Putamen node strength (time frame: Baseline/randomization and 12 weeks after baseline/randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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