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Therapeutic Massage for Generalized Anxiety Disorder (CALM)

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
massage
thermotherapy
relaxing environment
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring massage therapy, relaxation treatments

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Group Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

Therapeutic massage

Thermotherapy

Relaxation

Outcomes

Primary Outcome Measures

anxiety

Secondary Outcome Measures

worry, depression, disability

Full Information

First Posted
August 9, 2007
Last Updated
October 11, 2017
Sponsor
Kaiser Permanente
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00515242
Brief Title
Therapeutic Massage for Generalized Anxiety Disorder
Acronym
CALM
Official Title
Therapeutic Massage for Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
massage therapy, relaxation treatments

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Therapeutic massage
Arm Title
2
Arm Type
Active Comparator
Arm Description
Thermotherapy
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Relaxation
Intervention Type
Behavioral
Intervention Name(s)
massage
Intervention Description
therapeutic massage
Intervention Type
Behavioral
Intervention Name(s)
thermotherapy
Intervention Description
heat therapy
Intervention Type
Behavioral
Intervention Name(s)
relaxing environment
Intervention Description
time in a relaxing environment
Primary Outcome Measure Information:
Title
anxiety
Time Frame
6 months
Secondary Outcome Measure Information:
Title
worry, depression, disability
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen J. Sherman, PhD, MPH
Organizational Affiliation
Group Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

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Therapeutic Massage for Generalized Anxiety Disorder

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