Exercise and Behavioral Therapy Trial (EBT).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00007748
Recruitment Status : Completed
First Posted : January 1, 2001
Last Update Posted : June 26, 2015
United States Department of Defense
Information provided by:
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Persian Gulf Syndrome Behavioral: Aerobic exercise Behavioral: Cognitive behavioral therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1064 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (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
Study Start Date : March 1999
Study Completion Date : August 2001

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00007748

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Sponsors and Collaborators
VA Office of Research and Development
United States Department of Defense Identifier: NCT00007748     History of Changes
Other Study ID Numbers: 470
First Posted: January 1, 2001    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015

Keywords provided by VA Office of Research and Development:
aerobic exercise
cognitive behavioral therapy
Gulf War Illnesses

Additional relevant MeSH terms:
Persian Gulf Syndrome
Occupational Diseases