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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Collaborator: |
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 |
| 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 |
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
Hide Study 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| White River Jct., Vermont, United States, 05009 | |
| White River Junction Vamc | |
| Burlington, Vermont, United States | |
| United States, Virginia | |
| Richmond Vamc | |
| Richmond, Virginia, United States, 23249 | |
| 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 | |
| VA Puget Sound Healthcare System, Seattle Division | |
| Seattle, Washington, United States, 98108-1597 | |
| Puerto Rico | |
| San Juan Vamc | |
| San Juan, Puerto Rico, 00921-3201 | |
More Information
| 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 |
|
aerobic exercise cognitive behavioral therapy CBT Gulf War Illnesses GWI |
|
Pathologic Processes Disease Syndrome |
Disorders of Environmental Origin Occupational Diseases Persian Gulf Syndrome |
