NCT00515242

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2007

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

1.1 years

First QC Date

August 9, 2007

Last Update Submit

October 11, 2017

Conditions

Generalized Anxiety Disorder

Keywords

massage therapyrelaxation treatments

Outcome Measures

Primary Outcomes (1)

  • anxiety

    6 months

Secondary Outcomes (1)

  • worry, depression, disability

    6 months

Study Arms (3)

1

EXPERIMENTAL

Therapeutic massage

Behavioral: massage

2

ACTIVE COMPARATOR

Thermotherapy

Behavioral: thermotherapy

3

PLACEBO COMPARATOR

Relaxation

Behavioral: relaxing environment

Interventions

massageBEHAVIORAL

therapeutic massage

1
thermotherapyBEHAVIORAL

heat therapy

2
relaxing environmentBEHAVIORAL

time in a relaxing environment

3

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Member of Group Health, Seattle metropolitan area
  • Generalized Anxiety Disorder confirmed by SCID
  • At least moderate anxiety

You may not qualify if:

  • Serious mental health co-morbidity
  • Any life threatening condition
  • Currently receiving psychotherapy
  • Substantial alcohol use
  • Contraindications for massage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

MassageHyperthermia, Induced

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Karen J. Sherman, PhD, MPH

    Group Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2007

First Posted

August 13, 2007

Study Start

September 1, 2007

Primary Completion

October 1, 2008

Study Completion

August 1, 2009

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

US(1)