NCT01033851

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 17, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
4 months until next milestone

Results Posted

Study results publicly available

June 11, 2013

Completed
Last Updated

June 4, 2014

Status Verified

May 1, 2014

Enrollment Period

3.8 years

First QC Date

December 9, 2009

Results QC Date

February 21, 2013

Last Update Submit

May 29, 2014

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms.

    2 months

Study Arms (2)

Mindfulness Based Stress Reduction

ACTIVE COMPARATOR

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

Behavioral: Mindfulness Based Stress Reduction

Stress Management Education

ACTIVE COMPARATOR

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

Behavioral: Stress Management Education

Interventions

Mindfulness Based Stress ReductionBEHAVIORAL

8 week course

Mindfulness Based Stress Reduction
Stress Management EducationBEHAVIORAL

8 week course

Stress Management Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with generalized anxiety disorder
  • medically healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • 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.

    PMID: 28314552DERIVED

  • 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.

    PMID: 23541163DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Elizabeth Hoge
Organization
Massachusetts General Hospital
ehoge@partners.org
6177240859

Study Officials

  • Elizabeth A Hoge, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Psychiatrist

Study Record Dates

First Submitted

December 9, 2009

First Posted

December 17, 2009

Study Start

March 1, 2008

Primary Completion

January 1, 2012

Study Completion

February 1, 2013

Last Updated

June 4, 2014

Results First Posted

June 11, 2013

Record last verified: 2014-05

Locations

US(1)