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NCT04053582 · ClinicalTrials.gov registry record · NA

Augmented Mindfulness Training for Resilience in Early Life

A NA study, sponsored by Laureate Institute for Brain Research.

Completed
Registry status
NA
Development phase
83
Enrollment target

NCT04053582: Completed NA study, sponsored by Laureate Institute for Brain Research.

NCT04053582 is a NA study that has completed, run by Laureate Institute for Brain Research. The registered enrollment target is 83 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04053582, a NA study, has completed, sponsored by Laureate Institute for Brain Research.

COMPLETED
Registry status
NA
Development phase
83 participants
Enrollment target

Study Summary

This project aims to determine whether neurofeedback augmented mindfulness intervention increases the plasticity in brain areas affected by exposure to early life adversity in youth. The study will first establish the augmented mindfulness training protocol targeting the posterior cingulate cortex (PCC) with real-time fMRI neurofeedback for use with healthy control and ELA-exposed youth. Next, in addition to ongoing data collection with healthy controls, ELA-exposed youth will be randomly assigned to either complete the neurofeedback augmented mindfulness training (AMT) or sham condition protocol. Effect of augmented mindfulness training on state measures of mindfulness, perceived stress, and affect will be examined.

Primary Outcome

Percent signal change in the PCC for Focus - Describe condition contrast will be lower in the AMT relative to the Sham group during mindfulness practice.

Interventions

  • BEHAVIORAL AMT
  • BEHAVIORAL Sham

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2019-08-01
Est. Completion 2023-08-01
Phase NA

What the finished NCT04053582 record still lists

NCT04053582 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which AMT is the first listed.

NCT04053582 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04053582 about?

NCT04053582 is a clinical study titled "Augmented Mindfulness Training for Resilience in Early Life". This project aims to determine whether neurofeedback augmented mindfulness intervention increases the plasticity in brain areas affected by exposure to early life adversity in youth. The study will first establish the augmented mindfulness training protocol targeting the posterior cingulate cortex (...

What is the current status of trial NCT04053582?

This trial is currently completed. It is a NA study. The enrollment target is 83 participants. The study started on 2019-08-01. Estimated completion is 2023-08-01.

What interventions are being tested in trial NCT04053582?

The interventions under investigation include: AMT (BEHAVIORAL), Sham (BEHAVIORAL).

Who is sponsoring clinical trial NCT04053582?

This trial is sponsored by Laureate Institute for Brain Research, which has 45 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04053582's enrollment target sits among peer trials

83 990th of 2000 higher than 1,011 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04053582, the US trial registry maintained by the National Library of Medicine. NCT04053582 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.