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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

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.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Behavioral: Mindfulness Based Stress Reduction Behavioral: Stress Management Education Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects
Study Start Date : March 2008
Actual Primary Completion Date : January 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT01033851


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Elizabeth A Hoge, MD Massachusetts General Hospital