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NCT04254796 · ClinicalTrials.gov registry record · NA
Neural Mechanisms of Meditation Training in Healthy and Depressed Adolescents: An MRI Connectome Study
A NA study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT04254796 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 100 participants.
The verdict
NCT04254796, a NA study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Training for Awareness, Resilience, and Action (TARA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-06-19 |
| Est. Completion | 2021-12-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04254796
The ClinicalTrials.gov registry entry for NCT04254796 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Training for Awareness, Resilience, and Action (TARA) is the first listed.
NCT04254796 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04254796 about?
NCT04254796 is a clinical study titled "Neural Mechanisms of Meditation Training in Healthy and Depressed Adolescents: An MRI Connectome Study". 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 ...
What is the current status of trial NCT04254796?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2020-06-19. Estimated completion is 2021-12-20.
What interventions are being tested in trial NCT04254796?
The interventions under investigation include: Training for Awareness, Resilience, and Action (TARA) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04254796?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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