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OpenTrials
Completed

NCT Number: NCT00992875

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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Key information

Conditions

Age range

22 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mindfulness-Based Stress Reduction

Behavioral

Behavioral intervention, mindfulness meditation in form of yoga, sitting meditation, body scan and mindfulness to routine activities

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • European Commission
  • Mind and Life Institute, Hadley, Massachusetts

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 9, 2009
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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