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

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ClinicalTrials.gov Identifier: NCT01128309
Recruitment Status : Completed
First Posted : May 21, 2010
Last Update Posted : May 7, 2012
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Britta Holzel, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Behavioral: Stress Reduction Intervention Behavioral: Active Control intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Stress Reduction and Anxiety: Effects on the Function and Structure of the Brain
Study Start Date : May 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Stress Reduction Intervention
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



Primary Outcome Measures :
  1. brain activation and structure as assessed by MRI [ Time Frame: Day 1 (within two weeks before the intervention) ]
    BOLD functional MRI and structural MRI

  2. brain activation and structure as assessed by MRI [ Time Frame: Day 2 (within two weeks after the intervention) ]
    BOLD functional MRI and structural MRI



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128309


Locations
United States, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
European Commission
Investigators
Principal Investigator: Sara W Lazar, PhD Massachusetts General Hospital
Principal Investigator: Britta K Holzel, PhD Massachusetts General Hospital

Responsible Party: Britta Holzel, Research Fellow, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01128309     History of Changes
Other Study ID Numbers: 2010P000947
236975 ( Other Grant/Funding Number: European Commission )
First Posted: May 21, 2010    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders