Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elizabeth A. Hoge, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01033851
First received: December 9, 2009
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

Current therapies for Generalized Anxiety Disorder (GAD) have limited effectiveness. This study measures the efficacy of two different approaches to reducing anxiety and stress. One approach uses education, nutrition, exercise, and time management training, and another uses mindfulness meditation and yoga, which is taught as part of the Mindfulness-based stress reduction (MBSR) course, an 8-week manualized mindfulness intervention. We hypothesize that the two approaches will reduce anxiety in individuals with GAD in different ways. We will measure changes in stress hormones associated with these changes.


Condition Intervention Phase
Generalized Anxiety Disorder
Behavioral: Mindfulness Based Stress Reduction
Behavioral: Stress Management Education
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Active Symptoms of Generalized Anxiety Disorder [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The Hamilton Anxiety Scale (HAMA) was defined as the primary anxiety outcome variable. This scale has 14 items describing symptoms of anxiety, each answered on a 0-4 scale, with 0 for a single question generally representing no symptoms, and 4 representing severe levels of the symptom. The total score is calculated by adding all the items together, for a possible total score of 0 to 56.


Secondary Outcome Measures:
  • Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    This is an overal clinical measure of anxiety symptoms after examining and interviewing the patient. The scale is one global item, that scores from 1 (1= not ill at all) to 7 (7= among the most extremely ill).


Enrollment: 89
Study Start Date: March 2008
Study Completion Date: February 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mindfulness Based Stress Reduction
Mindfulness Based Stress Reduction (MBSR) is an 8-week group intervention that trains participants in mindfulness meditation techniques.
Behavioral: Mindfulness Based Stress Reduction
8 week course
Active Comparator: Stress Management Education
Stress Management Education (SME) is an 8-week group intervention that educates participants about stress physiology and health lifestyle changes.
Behavioral: Stress Management Education
8 week course

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with generalized anxiety disorder
  • medically healthy

Exclusion Criteria:

  • substance abuse
  • history of other psychiatric diagnoses such as psychosis, Obsessive Compulsive Disorder, PTSD
  • use of certain types of psychotherapy, meditation training, yoga
  • pregnant or lactating women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033851

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Elizabeth A Hoge, MD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elizabeth A. Hoge, MD, Assistant Psychiatrist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01033851     History of Changes
Other Study ID Numbers: 2008-P-000275, 5K23AT004432
Study First Received: December 9, 2009
Results First Received: February 21, 2013
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 21, 2014