Therapeutic Massage for Generalized Anxiety Disorder | NCT00515242

Studies
Therapeutic Massage for Generalized Anxiety Disorder

NCT00515242

Sponsor

Kaiser Permanente

Status

Completed

Last Update Posted

Oct 13, 2017Actual

Enrollment

68Actual

Phase

Phase 1Phase 2

Conditions

Generalized Anxiety Disorder

Interventions

massage
thermotherapy
relaxing environment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R21AT002560	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Oct 2008Actual

Completion Date

Aug 2009Actual

First Submitted Date

Aug 9, 2007

First Submission Date that Met QC Criteria

Aug 10, 2007

First Posted Date

Aug 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2017

Last Update Posted Date

Oct 13, 2017Actual

Name	Class
National Center for Complementary and Integrative Health (NCCIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Therapeutic massage	Behavioral: massage
2	Active Comparator	Thermotherapy	Behavioral: thermotherapy
3	Placebo Comparator	Relaxation	Behavioral: relaxing environment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
massage	Behavioral	therapeutic massage	1
thermotherapy

Measure	Description	Time Frame
anxiety		6 months

Measure	Description	Time Frame
worry, depression, disability		6 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karen J. Sherman, PhD, MPH	Group Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Group Health Research Institute		Seattle	Washington	98101	United States

Condition Browse Module

MeSH Terms

ID	Term
D000098647	Generalized Anxiety Disorder

Ancestor Terms

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008405	Massage
D006979	Hyperthermia, Induced

Ancestor Terms

ID	Term
D064746	Therapy, Soft Tissue
D026201	Musculoskeletal Manipulations
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided