Does Mindfulness Training Change the Processing of Social Threat?

May 4, 2012 updated by: Britta Holzel, Massachusetts General Hospital
Training in mindfulness, the non-judgmental observation of experiences as they arise in the present moment, has been increasingly and successfully applied to the treatment of normative stress conditions and mental disorders. Yet, the neurological mechanisms that underlie the reported improvements are still largely unknown. This longitudinal study will investigate the influence of mindfulness training on a key underpinning of mental health, namely emotion regulation, and its associated brain activity. Healthy participants will be randomly assigned to either a validated eight week Mindfulness-based stress reduction (MBSR) program or to a control condition. In a pre-post investigation, participants' subjective reactions to aversive emotional stimuli (affective facial expressions) will be assessed, as will the associated brain activation using functional magnetic resonance imaging (fMRI). The investigators hypothesize that after the training the MBSR participants will rate the pictures as less aversive compared to control participants. Furthermore, the MBSR participants will show a patter of brain activation indicative of improved emotion regulation, relative to control participants. Finally, the effect of MBSR on the gray matter structure of the brain will be investigated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • no previous significant meditation or yoga experience
  • eligible for MRI scanning (no metallic implants, not pregnant, not claustrophobic)
  • no significant previous meditation or yoga experience

Exclusion Criteria:

  • DSM-IV diagnosis for depression, manic episodes, GAD, social phobia, anorexia, bulimia, schizophrenia, ADHD, substance dependency/abuse, suicidality
  • ineligible for MRI scanning (metallic implants, pregnant, claustrophobic)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BOLD signal on a 1.5T MRI scanner
Time Frame: the second time-point will take place eight weeks after the first data collection
the second time-point will take place eight weeks after the first data collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

European Commission
Mind and Life Institute, Hadley, Massachusetts

Investigators

  • Principal Investigator: Sara W Lazar, PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

September 28, 2009

First Submitted That Met QC Criteria

October 7, 2009

First Posted (Estimate)

October 9, 2009

Study Record Updates

Last Update Posted (Estimate)

May 7, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2008A057212
  • FP7-PEOPLE-IOF-2008: 236975

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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