Therapeutic Massage for Generalized Anxiety Disorder (CALM)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00515242
First received: August 9, 2007
Last updated: March 20, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Massage for Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

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 ]

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

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
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, see Learn About Clinical Studies.

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

Locations
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
Investigators
Principal Investigator: Karen J. Sherman, PhD, MPH Group Health
  More Information

No publications provided

Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT00515242     History of Changes
Other Study ID Numbers: R21 AT002560, R21AT002560
Study First Received: August 9, 2007
Last Updated: March 20, 2014
Health Authority: United States: Federal Government

Keywords provided by Group Health Cooperative:
massage therapy
relaxation treatments

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 01, 2014