Does Mindfulness Training Change the Processing of Social Threat?

Healthy Clinical Trial

Official title:

Does Mindfulness Training Change the Processing of Social Threat?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992875
• Other study ID #: 2008A057212
• Secondary ID: FP7-PEOPLE-IOF-2
• Status: Completed
• Phase: N/A
• First received: September 28, 2009
• Last updated: May 4, 2012
• Start date: January 2009
• Est. completion date: February 2011

Study information

• Verified date: May 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy
• Stress

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	European Commission, Mind and Life Institute, Hadley, Massachusetts

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOLD signal on a 1.5T MRI scanner		the second time-point will take place eight weeks after the first data collection	No