Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Behavioral: Mindfulness Based Stress Reduction; Behavioral: Stress Management Education

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Elizabeth A Hoge, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Hoge EA, Guidos BM, Mete M, Bui E, Pollack MH, Simon NM, Dutton MA. Effects of mindfulness meditation on occupational functioning and health care utilization in individuals with anxiety. J Psychosom Res. 2017 Apr;95:7-11. doi: 10.1016/j.jpsychores.2017.01.011. Epub 2017 Jan 23.
• Hoge EA, Bui E, Marques L, Metcalf CA, Morris LK, Robinaugh DJ, Worthington JJ, Pollack MH, Simon NM. Randomized controlled trial of mindfulness meditation for generalized anxiety disorder: effects on anxiety and stress reactivity. J Clin Psychiatry. 2013 Aug;74(8):786-92. doi: 10.4088/JCP.12m08083.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: December 9, 2009
• First Submitted That Met QC Criteria: December 15, 2009
• First Posted (Estimate): December 17, 2009

Study Record Updates

• Last Update Posted (Estimate): June 4, 2014
• Last Update Submitted That Met QC Criteria: May 29, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2008-P-000275; 5K23AT004432 (U.S. NIH Grant/Contract)