Stress Reduction and Anxiety: Effects on the Function and Structure of the Brain

May 4, 2012 updated by: Britta Holzel, Massachusetts General Hospital
The aim of the study is to test whether Generalized Anxiety Disorder (GAD) patients that participate in a Stress Reduction Intervention show a brain activation pattern (assessed by MRI) indicative of improved emotion regulation compared to an active control intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

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
      • Charlestown, Massachusetts, United States, 02129
        • 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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • participation in the study 'Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects" by Dr. Elizabeth Hoge

Exclusion Criteria:

  • metallic implants
  • left handed
  • epileptic seizures
  • head trauma
  • weight over 350 pounds
  • claustrophobia

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stress Reduction Intervention
Behavioral: Stress Reduction Intervention
eight week group program, plus daily homework practice
Active Comparator: Active Control Condition
Behavioral: Active Control intervention
weekly group meetings for eight weeks, plus daily homework practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
brain activation and structure as assessed by MRI
Time Frame: Day 1 (within two weeks before the intervention)
BOLD functional MRI and structural MRI
Day 1 (within two weeks before the intervention)
brain activation and structure as assessed by MRI
Time Frame: Day 2 (within two weeks after the intervention)
BOLD functional MRI and structural MRI
Day 2 (within two weeks after the intervention)

Collaborators and Investigators

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

Sponsor

Massachusetts General Hospital

Collaborators

European Commission

Investigators

  • Principal Investigator: Sara W Lazar, PhD, Massachusetts General hospital
  • Principal Investigator: Britta K Holzel, PhD, Massachusetts General hospital

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

May 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 20, 2010

First Posted (Estimate)

May 21, 2010

Study Record Updates

Last Update Posted (Estimate)

May 7, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010P000947
  • 236975 (Other Grant/Funding Number: European Commission)

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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