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Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

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ClinicalTrials.gov Identifier: NCT01033851
Recruitment Status : Completed
First Posted : December 17, 2009
Results First Posted : June 11, 2013
Last Update Posted : June 4, 2014
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Elizabeth A. Hoge, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE December 9, 2009
First Posted Date  ICMJE December 17, 2009
Results First Submitted Date  ICMJE February 21, 2013
Results First Posted Date  ICMJE June 11, 2013
Last Update Posted Date June 4, 2014
Study Start Date  ICMJE March 2008
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2013)
Active Symptoms of Generalized Anxiety Disorder [ Time Frame: 2 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2009)
Active Symptoms of Generalized Anxiety Disorder [ Time Frame: 10 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2013)
Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms. [ Time Frame: 2 months ]
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).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects
Official Title  ICMJE Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Generalized Anxiety Disorder
Intervention  ICMJE
  • Behavioral: Mindfulness Based Stress Reduction
    8 week course
  • Behavioral: Stress Management Education
    8 week course
Study Arms  ICMJE
  • Active Comparator: Mindfulness Based Stress Reduction
    Mindfulness Based Stress Reduction (MBSR) is an 8-week group intervention that trains participants in mindfulness meditation techniques.
    Intervention: Behavioral: Mindfulness Based Stress Reduction
  • 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.
    Intervention: Behavioral: Stress Management Education
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2013)
89
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2009)
60
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01033851
Other Study ID Numbers  ICMJE 2008-P-000275
5K23AT004432 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elizabeth A. Hoge, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Elizabeth A Hoge, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP