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NCT01320969 · ClinicalTrials.gov registry record · NA

Could Meditation Modulate the Neurobiology of Learning Not to Fear?

A NA study of Healthy Individuals and Highly Stressed, sponsored by Massachusetts General Hospital.

Completed
Registry status
NA
Development phase
85
Enrollment target
1
Study location

NCT01320969: Completed NA study of Healthy Individuals and Highly Stressed, sponsored by Massachusetts General Hospital.

NCT01320969 is a NA study of Healthy Individuals and Highly Stressed that has completed, run by Massachusetts General Hospital. The registered enrollment target is 85 participants, below the 97-participant average among 3 other Healthy Individuals trials with a reported enrollment target (12% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01320969, a NA study of Healthy Individuals and Highly Stressed, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
NA
Development phase
85 participants
Enrollment target
1
Study location

Study Summary

It is well-established that the practice of mindfulness meditation leads to improvements in mental health and well-being and the cultivation of positive emotions. However, the neural mechanisms of these improvements are largely unknown. A few recent studies suggest that mindfulness meditation impacts the structure and function of the ventromedial prefrontal cortex, the hippocampus, and the amygdala. Interestingly, recent studies have shown that these regions are part of a brain circuit that is critical for the extinction of conditioned fear responses, and for the retention of fear extinction memory. Building on the overlap of these regions and on conceptual considerations, the project investigates whether mindfulness meditation could influence one's capacity to retain the memory of fear extinction. Meditation-naïve participants will be randomized to either a mindfulness-meditation based training or an active control training that controls for all mindfulness-unspecific components. Participants will undergo a fear conditioning, extinction and extinction recall protocol in an MRI scanner before and after the trainings. We hypothesize that participants who have practiced mindfulness meditation will show greater improvements in fear extinction memory after the course, and that these improvements will be correlated with anatomical and functional changes in the brain regions of interest. Improvements in fear extinction memory will also be related to improvements in self-reported psychological well-being. Merging the fields of an ancient spiritual tradition and a fundamental learning mechanism, the project investigates the underlying neural mechanisms of a practice for the enhancement of mental health and well-being.

Primary Outcome

We will measure the change in functional MRI during fear conditioning, extinction, and extinction retention memory pre to post intervention. Furthermore, we will measure changes in structural MRI data, DTI data and resting state fMRI data.

Interventions

  • BEHAVIORAL Mindfulness-Based Stress Reduction course

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Charlestown

Trial Details

FieldValue
Enrollment Target 85 participants
Start Date 2010-12
Est. Completion 2012-05
Phase NA
Massachusetts General Hospital

2,032 total trials

What the finished NCT01320969 record still lists

NCT01320969 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 97-participant average among 3 other Healthy Individuals trials with a reported enrollment target (12% lower).

The record links to 2 conditions, with Healthy Individuals appearing as the primary indexed condition, and to 1 intervention - of which Mindfulness-Based Stress Reduction course is the first listed.

NCT01320969 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01320969 about?

NCT01320969 is a clinical study titled "Could Meditation Modulate the Neurobiology of Learning Not to Fear?". It is well-established that the practice of mindfulness meditation leads to improvements in mental health and well-being and the cultivation of positive emotions. However, the neural mechanisms of these improvements are largely unknown. A few recent studies suggest that mindfulness meditation impact...

What is the current status of trial NCT01320969?

This trial is currently completed. It is a NA study. The enrollment target is 85 participants. The study started on 2010-12. Estimated completion is 2012-05.

What conditions does trial NCT01320969 study?

This clinical trial studies the following conditions: Healthy Individuals, Highly Stressed.

What interventions are being tested in trial NCT01320969?

The interventions under investigation include: Mindfulness-Based Stress Reduction course (BEHAVIORAL).

Who is sponsoring clinical trial NCT01320969?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01320969 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01320969, the US trial registry maintained by the National Library of Medicine. NCT01320969 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.