Exercise and Behavioral Therapy Trial (EBT).

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00007748
First received: December 29, 2000
Last updated: April 25, 2008
Last verified: February 2003
  Purpose

This trial is a study of Gulf War era veterans who have unexplained chronic medical symptoms such as pain, fatigue, and/or cognitive difficulties. The treatments to be studied, cognitive behavior therapy (CBT) and aerobic exercise, have been shown to be effective in alleviating symptoms in individuals with other similar types of illnesses, such as chronic fatigue syndrome and fibromyalgia. This is a Phase 3, 2X2 factorial designed study. All study participants are assigned to one of four treatment groups - CBT and aerobic exercise, aerobic exercise alone, CBT alone or usual and customary care. This study durations is 28 months; 1092 participants were enrolled and will be followed in clinic at 3, 6 and 12 months after enrollment.


Condition Intervention Phase
Persian Gulf Syndrome
Behavioral: Aerobic exercise
Behavioral: Cognitive behavioral therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CSP#470 - A Randomized, Multi-Center, Controlled Trial of Multi-Modal Therapy in Veterans With Gulf War Illnesses

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 1064
Study Start Date: March 1999
Estimated Study Completion Date: August 2001
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Gulf War era veterans deployed to the South West Asia theater of operations between August 1990 and August 1991 who have two of the following three symptoms that began after 1990 lasting more than 6 months and continuing to present - fatigue that limits usual activities (work, recreation or social), musculoskeletal pain involving more than one region of the body or neurocognitive dysfunction (self-reported difficulties in memory, concentration, or attention).

  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: NCT00007748

  Hide Study Locations
Locations
United States, Alabama
Birmingham Vamc Birmingham Vamc
Birmingham, Alabama, United States, 35233
Birmingham Vamc
Birmingham, Alabama, United States, 35233
United States, California
Naval Health Research Center, San Diego
San Diego, California, United States, 92186-5122
Naval Health Research Center, San Diego
San Diego, California, United States, 92152
Naval Health Research Center, San Diego
San Diego, California, United States, 92106-6000
San Francisco Vamc
San Francisco, California, United States, 94121
United States, Connecticut
VA CT Healthcare System, West Haven
West Haven, Connecticut, United States, 06516
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Maryland
Uniformed Services University
Bethesda, Maryland, United States, 20814-4799
United States, Massachusetts
Boston Vamc
Boston, Massachusetts, United States, 02114
Boston Vamc
Boston, Massachusetts, United States, 02130
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Missouri
John Cochran VAMC, Saint Louis
St. Louis, Missouri, United States, 63106
United States, New Jersey
VA New Jersey Health Care System, East Orange
East Orange, New Jersey, United States, 07018
United States, New Mexico
Vamc - Albuquerque
Albuquerque, New Mexico, United States, 87108
United States, New York
New York Harbor VA Healthcare System, Brooklyn Campus
Brooklyn, New York, United States, 11209
United States, North Dakota
Fargo Vamc
Fargo, North Dakota, United States, 58102
United States, Ohio
Vamc - Dayton
Dayton, Ohio, United States, 45428
United States, Oregon
Portland Vamc
Portland, Oregon, United States, 97207
United States, Pennsylvania
Philadelphia Vamc
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Houston Vamc
Houston, Texas, United States, 77030
Audie L. Murphy Memorial Veterans Hospital, San Antonio
San Antonio, Texas, United States, 78284
United States, Vermont
White River Junction Vamc
Burlington, Vermont, United States
White River Junction Vamc
White River Jct., Vermont, United States, 05009
United States, Virginia
Richmond Vamc
Richmond, Virginia, United States, 23249
United States, Washington
VA Puget Sound Healthcare System, Seattle Division
Seattle, Washington, United States, 98108-1597
VA Puget Sound Healthcare System, Seattle Division
Seattle, Washington, United States, 98108
Puerto Rico
San Juan Vamc
San Juan, Puerto Rico, 00921-3201
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00007748     History of Changes
Other Study ID Numbers: 470
Study First Received: December 29, 2000
Last Updated: April 25, 2008
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
aerobic exercise
cognitive behavioral therapy
CBT
Gulf War Illnesses
GWI

Additional relevant MeSH terms:
Persian Gulf Syndrome
Occupational Diseases

ClinicalTrials.gov processed this record on July 24, 2014