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

This study has been completed.
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Britta Holzel, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01128309
First received: May 19, 2010
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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 Intervention
Generalized Anxiety Disorder
Behavioral: Stress Reduction Intervention
Behavioral: Active Control intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Stress Reduction and Anxiety: Effects on the Function and Structure of the Brain

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • brain activation and structure as assessed by MRI [ Time Frame: Day 1 (within two weeks before the intervention) ] [ Designated as safety issue: No ]
    BOLD functional MRI and structural MRI

  • brain activation and structure as assessed by MRI [ Time Frame: Day 2 (within two weeks after the intervention) ] [ Designated as safety issue: No ]
    BOLD functional MRI and structural MRI


Enrollment: 29
Study Start Date: May 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Britta Holzel, Research Fellow, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01128309     History of Changes
Other Study ID Numbers: 2010P000947, 236975
Study First Received: May 19, 2010
Last Updated: May 4, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014