Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects
|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|
|Primary Completion Date :||January 2012|
|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).
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|