Therapeutic Massage for Generalized Anxiety Disorder - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00515242

Purpose

The purpose of this study is to compare the relative effectiveness of three relaxation treatments (therapeutic massage, thermotherapy, and time in a relaxing environment) in reducing anxiety in persons with Generalized Anxiety Disorder.

Condition	Intervention	Phase
Generalized Anxiety Disorder	Behavioral: massage Behavioral: thermotherapy Behavioral: relaxing environment	Phase I Phase II

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Therapeutic Massage for Generalized Anxiety Disorder

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

anxiety [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

worry, depression, disability [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	September 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Therapeutic massage	Behavioral: massage therapeutic massage
2: Active Comparator Thermotherapy	Behavioral: thermotherapy heat therapy
3: Placebo Comparator Relaxation	Behavioral: relaxing environment time in a relaxing environment

Detailed Description:

Anxiety and stress are costly problems that afflict millions of American adults. Together, they are among the most common reasons for which adults use complementary and alternative medical (CAM) therapies as well as more conventional relaxation therapies. Although massage is one of the most popular CAM treatments for anxiety, its effectiveness for this problem has never been rigorously evaluated. This study is designed to evaluate the effectiveness of massage as a treatment for a diagnosed anxiety disorder. Massage will be compared with two other relaxing treatments: thermotherapy and time in a relaxing environment, which reflect the types of activities that persons with anxiety might try to relieve their symptoms.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Member of Group Health, Seattle metropolitan area
Generalized Anxiety Disorder confirmed by SCID
At least moderate anxiety

Exclusion Criteria:

Serious mental health co-morbidity
Any life threatening condition
Currently receiving psychotherapy
Substantial alcohol use
Contraindications for massage

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515242

Locations

United States, Washington
Group Health
Seattle, Washington, United States, 98101

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Karen J. Sherman, PhD, MPH

Group Health

More Information

Responsible Party:	Group Health Center for Health Studies ( Karen Sherman )
Study ID Numbers:	R21 AT002560
Study First Received:	August 9, 2007
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00515242
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

massage therapy
relaxation treatments

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009