Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

Generalized Anxiety Disorder Clinical Trial

Official title:

Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033851
• Other study ID #: 2008-P-000275
• Secondary ID: 5K23AT004432
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2009
• Last updated: May 29, 2014
• Start date: March 2008
• Est. completion date: February 2013

Study information

• Verified date: May 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: February 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Behavioral:
• Mindfulness Based Stress Reduction
8 week course
• Stress Management Education
8 week course

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Active Symptoms of Generalized Anxiety Disorder	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.	2 months	No
Secondary	Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms.	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).	2 months	No