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Does Mindfulness Training Change the Processing of Social Threat?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00992875
First Posted: October 9, 2009
Last Update Posted: May 7, 2012
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.
Collaborators:
Mind and Life Institute, Hadley, Massachusetts
European Commission
Information provided by (Responsible Party):
Britta Holzel, Massachusetts General Hospital
September 28, 2009
October 9, 2009
May 7, 2012
January 2009
February 2011   (Final data collection date for primary outcome measure)
BOLD signal on a 1.5T MRI scanner [ Time Frame: the second time-point will take place eight weeks after the first data collection ]
Same as current
Complete list of historical versions of study NCT00992875 on ClinicalTrials.gov Archive Site
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Does Mindfulness Training Change the Processing of Social Threat?
Does Mindfulness Training Change the Processing of Social Threat?
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.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Healthy
  • Stress
Behavioral: Mindfulness-Based Stress Reduction
Behavioral intervention, mindfulness meditation in form of yoga, sitting meditation, body scan and mindfulness to routine activities
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
February 2011
February 2011   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
22 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00992875
2008A057212
FP7-PEOPLE-IOF-2008: 236975
Yes
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Britta Holzel, Massachusetts General Hospital
Massachusetts General Hospital
  • Mind and Life Institute, Hadley, Massachusetts
  • European Commission
Principal Investigator: Sara W Lazar, PhD Massachusetts General Hospital
Massachusetts General Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP