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

August 9, 2007
March 20, 2014
September 2007
October 2008   (final data collection date for primary outcome measure)
anxiety [ Time Frame: 6 months ] [ Designated as safety issue: No ]
anxiety [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00515242 on ClinicalTrials.gov Archive Site
worry, depression, disability [ Time Frame: 6 months ] [ Designated as safety issue: No ]
worry, depression, disability [ Time Frame: 6 months ]
Not Provided
Not Provided
 
Therapeutic Massage for Generalized Anxiety Disorder
Therapeutic Massage for Generalized Anxiety Disorder

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Generalized Anxiety Disorder
  • Behavioral: massage
    therapeutic massage
  • Behavioral: thermotherapy
    heat therapy
  • Behavioral: relaxing environment
    time in a relaxing environment
  • Experimental: 1
    Therapeutic massage
    Intervention: Behavioral: massage
  • Active Comparator: 2
    Thermotherapy
    Intervention: Behavioral: thermotherapy
  • Placebo Comparator: 3
    Relaxation
    Intervention: Behavioral: relaxing environment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
August 2009
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00515242
R21 AT002560, R21AT002560
Yes
Group Health Cooperative
Group Health Cooperative
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Karen J. Sherman, PhD, MPH Group Health
Group Health Cooperative
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP