Does Mindfulness Training Change the Processing of Social Threat?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00992875
Recruitment Status : Completed
First Posted : October 9, 2009
Last Update Posted : May 7, 2012
Mind and Life Institute, Hadley, Massachusetts
European Commission
Information provided by (Responsible Party):
Britta Holzel, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Stress Behavioral: Mindfulness-Based Stress Reduction Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Does Mindfulness Training Change the Processing of Social Threat?
Study Start Date : January 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Intervention Details:
  • Behavioral: Mindfulness-Based Stress Reduction
    Behavioral intervention, mindfulness meditation in form of yoga, sitting meditation, body scan and mindfulness to routine activities

Primary Outcome Measures :
  1. BOLD signal on a 1.5T MRI scanner [ Time Frame: the second time-point will take place eight weeks after the first data collection ]

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00992875

United States, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
Mind and Life Institute, Hadley, Massachusetts
European Commission
Principal Investigator: Sara W Lazar, PhD Massachusetts General Hospital

Additional Information:
Responsible Party: Britta Holzel, Research Fellow, Massachusetts General Hospital Identifier: NCT00992875     History of Changes
Other Study ID Numbers: 2008A057212
FP7-PEOPLE-IOF-2008: 236975
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 2012

Keywords provided by Britta Holzel, Massachusetts General Hospital:
Healthy but stressed individuals