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Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction
Stress Management Education
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mindfulness Based Stress Reduction

Stress Management Education

Arm Description

Mindfulness Based Stress Reduction (MBSR) is an 8-week group intervention that trains participants in mindfulness meditation techniques.

Stress Management Education (SME) is an 8-week group intervention that educates participants about stress physiology and health lifestyle changes.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
December 9, 2009
Last Updated
May 29, 2014
Sponsor
Massachusetts General Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01033851
Brief Title
Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects
Official Title
Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Based Stress Reduction
Arm Type
Active Comparator
Arm Description
Mindfulness Based Stress Reduction (MBSR) is an 8-week group intervention that trains participants in mindfulness meditation techniques.
Arm Title
Stress Management Education
Arm Type
Active Comparator
Arm Description
Stress Management Education (SME) is an 8-week group intervention that educates participants about stress physiology and health lifestyle changes.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction
Intervention Description
8 week course
Intervention Type
Behavioral
Intervention Name(s)
Stress Management Education
Intervention Description
8 week course
Primary Outcome Measure Information:
Title
Active Symptoms of Generalized Anxiety Disorder
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms.
Description
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).
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Hoge, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28314552
Citation
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.
Results Reference
derived
PubMed Identifier
23541163
Citation
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.
Results Reference
derived

Learn more about this trial

Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

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