Neural Correlates of Stress Reduction

Stress Clinical Trial

Official title:

Structural and Functional Mechanisms of Stress Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488422
• Other study ID #: AT006344
• Status: Completed
• Phase: N/A
• First received: December 5, 2011
• Last updated: January 14, 2015
• Start date: December 2011
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will identify neural mechanisms associated with changes in emotion regulation following participation in stress reduction programs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 18-50 years of age

• Right-handed

• Stressed

Exclusion Criteria:

• Lifetime history of schizophrenia or psychosis

• Psychiatric illness

• History of seizure or significant head trauma

• Use of psychotropic medications

• Metallic implants or devices contraindicating magnetic resonance imaging

• Claustrophobia

• Pregnancy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Emotional Stress
• Life Stress
• Psychological Stress
• Social Stress
• Stress
• Stress, Psychological

Intervention

Behavioral:
• Stress Reduction
We are comparing 2 well-studied approaches to stress reduction. All participants will receive stress reduction instructions that have already been proven to effectively reduce stress. Our goal is to compare the neural mechanisms associated with both approaches.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in gray matter structure	Study participants will undergo an MRI scan before and after attending an 8-week stress reduction program.	8 weeks	No
Secondary	Emotion regulation	Study participants will do an emotion regulation task while they are in the MRI scanner. We will assess brain activity and skin conductance during the task. Changes in these measures will be assessed before and after enrollment in the stress reduction program	8-weeks	No

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