Exercise and Behavioral Therapy Trial (EBT).

NCT00007748 | Completed Phase 3

• 1 other identifier: 470
• Study Type: interventional
• Target: 1,064
• Locations: 2 countries
• Sites: 29

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.

Conditions

Persian Gulf Syndrome

Keywords

aerobic exercise; cognitive behavioral therapy; CBT; Gulf War Illnesses; GWI

Interventions

Aerobic exercise BEHAVIORAL

Cognitive behavioral therapy BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• United States Department of Defense: collaborator

Study Sites (29)

Birmingham Vamc Birmingham Vamc

Birmingham, Alabama, 35233, United States

Location

Birmingham Vamc

Birmingham, Alabama, 35233, United States

Location

Naval Health Research Center, San Diego

San Diego, California, 92106-6000, United States

Location

Naval Health Research Center, San Diego

San Diego, California, 92152, United States

Location

Naval Health Research Center, San Diego

San Diego, California, 92186-5122, United States

Location

San Francisco Vamc

San Francisco, California, 94121, United States

Location

VA CT Healthcare System, West Haven

West Haven, Connecticut, 06516, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5001, United States

Location

Uniformed Services University

Bethesda, Maryland, 20814-4799, United States

Location

Boston Vamc

Boston, Massachusetts, 02114, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Boston Vamc

Boston, Massachusetts, 02130, United States

Location

John Cochran VAMC, Saint Louis

St Louis, Missouri, 63106, United States

Location

VA New Jersey Health Care System, East Orange

East Orange, New Jersey, 07018, United States

Location

Vamc - Albuquerque

Albuquerque, New Mexico, 87108, United States

Location

New York Harbor VA Healthcare System, Brooklyn Campus

Brooklyn, New York, 11209, United States

Location

Fargo Vamc

Fargo, North Dakota, 58102, United States

Location

Vamc - Dayton

Dayton, Ohio, 45428, United States

Location

Portland Vamc

Portland, Oregon, 97207, United States

Location

Philadelphia Vamc

Philadelphia, Pennsylvania, 19104, United States

Location

Houston Vamc

Houston, Texas, 77030, United States

Location

Audie L. Murphy Memorial Veterans Hospital, San Antonio

San Antonio, Texas, 78284, United States

Location

White River Junction Vamc

Burlington, Vermont, United States

Location

White River Junction Vamc

White River Jct., Vermont, 05009, United States

Location

Richmond Vamc

Richmond, Virginia, 23249, United States

Location

VA Puget Sound Healthcare System, Seattle Division

Seattle, Washington, 98108-1597, United States

Location

VA Puget Sound Healthcare System, Seattle Division

Seattle, Washington, 98108, United States

Location

San Juan Vamc

San Juan, 00921-3201, Puerto Rico

Location

MeSH Terms

Conditions

Persian Gulf Syndrome

Interventions

Exercise; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED

Study Record Dates

• First Submitted: December 29, 2000
• First Posted: January 1, 2001
• Study Start: March 1, 1999
• Study Completion: August 1, 2001
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

US (28); PR (1)