Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01033851|
Recruitment Status : Completed
First Posted : December 17, 2009
Results First Posted : June 11, 2013
Last Update Posted : June 4, 2014
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
- 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.
- 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).
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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Elizabeth A Hoge, MD||Massachusetts General Hospital|