Therapeutic Massage for Generalized Anxiety Disorder (CALM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00515242
Recruitment Status : Completed
First Posted : August 13, 2007
Last Update Posted : October 13, 2017
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
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 or disease Intervention/treatment Phase
Generalized Anxiety Disorder Behavioral: massage Behavioral: thermotherapy Behavioral: relaxing environment Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Massage for Generalized Anxiety Disorder
Study Start Date : September 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 1
Therapeutic massage
Behavioral: massage
therapeutic massage

Active Comparator: 2
Behavioral: thermotherapy
heat therapy

Placebo Comparator: 3
Behavioral: relaxing environment
time in a relaxing environment

Primary Outcome Measures :
  1. anxiety [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. worry, depression, disability [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00515242

United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Kaiser Permanente
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Karen J. Sherman, PhD, MPH Group Health

Responsible Party: Kaiser Permanente Identifier: NCT00515242     History of Changes
Other Study ID Numbers: R21AT002560 ( U.S. NIH Grant/Contract )
R21AT002560 ( U.S. NIH Grant/Contract )
First Posted: August 13, 2007    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by Kaiser Permanente:
massage therapy
relaxation treatments

Additional relevant MeSH terms:
Anxiety Disorders
Pathologic Processes
Mental Disorders