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Therapeutic Massage for Generalized Anxiety Disorder (CALM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00515242
First Posted: August 13, 2007
Last Update Posted: October 13, 2017
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.
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Kaiser Permanente
  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 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Massage for Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • anxiety [ Time Frame: 6 months ]

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

Enrollment: 68
Study Start Date: September 2007
Study Completion Date: August 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Therapeutic massage
Behavioral: massage
therapeutic massage
Active Comparator: 2
Thermotherapy
Behavioral: thermotherapy
heat therapy
Placebo Comparator: 3
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00515242


Locations
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)
Investigators
Principal Investigator: Karen J. Sherman, PhD, MPH Group Health
  More Information

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00515242     History of Changes
Other Study ID Numbers: R21AT002560 ( U.S. NIH Grant/Contract )
First Submitted: August 9, 2007
First Posted: August 13, 2007
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by Kaiser Permanente:
massage therapy
relaxation treatments

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders