Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

NCT ID: NCT01033851

Last Updated: 2014-06-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Generalized Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Mindfulness Based Stress Reduction

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

Group Type ACTIVE_COMPARATOR

Mindfulness Based Stress Reduction

Intervention Type BEHAVIORAL

8 week course

Stress Management Education

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

Group Type ACTIVE_COMPARATOR

Stress Management Education

Intervention Type BEHAVIORAL

8 week course

Interventions

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Mindfulness Based Stress Reduction

8 week course

Intervention Type BEHAVIORAL

Stress Management Education

8 week course

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth A. Hoge, MD

Assistant Psychiatrist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth A Hoge, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28314552 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23541163 (View on PubMed)

Other Identifiers

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5K23AT004432

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2008-P-000275

Identifier Type: -

Identifier Source: org_study_id

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