Exercise and Behavioral Therapy Trial (EBT).

This study has been completed.

First Received: December 29, 2000 Last Updated: April 25, 2008 History of Changes

Sponsors and Collaborators:	Department of Veterans Affairs Department of Defense
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00007748

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Factorial Assignment, Efficacy Study
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:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007748

Show 36 Study Locations

Sponsors and Collaborators

Department of Veterans Affairs

Department of Defense

More Information

No publications provided

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

Keywords provided by Department of Veterans Affairs:

aerobic exercise
cognitive behavioral therapy
CBT
Gulf War Illnesses
GWI

Study placed in the following topic categories:

Disorders of Environmental Origin
Occupational Diseases
Persian Gulf Syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

Disorders of Environmental Origin
Occupational Diseases
Persian Gulf Syndrome

ClinicalTrials.gov processed this record on July 02, 2009