Neural Correlates of Stress Reduction

January 14, 2015 updated by: Sara W Lazar, Massachusetts General Hospital

Structural and Functional Mechanisms of Stress Reduction

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 1
Both groups will receive stress reduction materials. We expect both groups to achieve similar amounts of stress reduction, but to use different brain regions to do so.
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.
ACTIVE_COMPARATOR: Group 2
Both groups will receive stress reduction materials. We expect both groups to achieve similar amounts of stress reduction, but to use different brain regions to do so.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in gray matter structure
Time Frame: 8 weeks
Study participants will undergo an MRI scan before and after attending an 8-week stress reduction program.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotion regulation
Time Frame: 8-weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 6, 2011

First Posted (ESTIMATE)

December 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 15, 2015

Last Update Submitted That Met QC Criteria

January 14, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT006344

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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