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Cognitive Behavioral Therapy and Aerobic Exercise for Gulf War Veterans' Illnesses
A Randomized Controlled Trial
Sam T. Donta, MD;
Daniel J. Clauw, MD;
Charles C. Engel, Jr, MD, MPH;
Peter Guarino, MPH;
Peter Peduzzi, PhD;
David A. Williams, PhD;
James S. Skinner, PhD;
André Barkhuizen, MD;
Thomas Taylor, MD;
Lewis E. Kazis, ScD;
Stephanie Sogg, PhD;
Stephen C. Hunt, MD;
Cynthia M. Dougherty, PhD;
Ralph D. Richardson, PhD;
Charles Kunkel, MD;
William Rodriguez, MD;
Edwin Alicea, MD;
Philippe Chiliade, MD;
Margaret Ryan, MD, MPH;
Gregory C. Gray, MD, MPH;
Larry Lutwick, MD;
Dorothy Norwood, MD;
Samantha Smith, PhD;
Michael Everson, PhD;
Warren Blackburn, MD;
Wade Martin, MD;
J. McLeod Griffiss, MD;
Robert Cooper, MD;
Ed Renner, PhD, MPH;
James Schmitt, MD;
Cynthia McMurtry, MD;
Manisha Thakore, MD;
Deanna Mori, PhD;
Robert Kerns, PhD;
Maryann Park, MD;
Sally Pullman-Mooar, MD;
Jack Bernstein, MD;
Paul Hershberger, PhD;
Don C. Salisbury, DO;
John R. Feussner, MD, MPH; for the VA Cooperative Study #470 Study Group
JAMA. 2003;289:1396-1404.
Context Gulf War veterans' illnesses (GWVI), multisymptom illnesses characterized by persistent pain, fatigue, and cognitive symptoms, have been reported by many Gulf War veterans. There are currently no effective therapies available to treat GWVI.
Objective To compare the effectiveness of cognitive behavioral therapy (CBT), exercise, and the combination of both for improving physical functioning and reducing the symptoms of GWVI.
Design, Setting, and Patients Randomized controlled 2 x 2 factorial trial conducted from April 1999 to September 2001 among 1092 Gulf War veterans who reported at least 2 of 3 symptom types (fatigue, pain, and cognitive) for more than 6 months and at the time of screening. Treatment assignment was unmasked except for a masked assessor of study outcomes at each clinical site (18 Department of Veterans Affairs [VA] and 2 Department of Defense [DOD] medical centers).
Interventions Veterans were randomly assigned to receive usual care (n = 271), consisting of any and all care received from inside or outside the VA or DOD health care systems; CBT plus usual care (n = 286); exercise plus usual care (n = 269); or CBT plus exercise plus usual care (n = 266). Exercise sessions were 60 minutes and CBT sessions were 60 to 90 minutes; both met weekly for 12 weeks.
Main Outcome Measures The primary end point was a 7-point or greater increase (improvement) on the Physical Component Summary scale of the Veterans Short Form 36-Item Health Survey at 12 months. Secondary outcomes were standardized measures of pain, fatigue, cognitive symptoms, distress, and mental health functioning. Participants were evaluated at baseline and at 3, 6, and 12 months.
Results The percentage of veterans with improvement in physical function at 1 year was 11.5% for usual care, 11.7% for exercise alone, 18.4% for CBT plus exercise, and 18.5% for CBT alone. The adjusted odds ratios (OR) for improvement in exercise, CBT, and exercise plus CBT vs usual care were 1.07 (95% confidence interval [CI], 0.63-1.82), 1.72 (95% CI, 0.91-3.23), and 1.84 (95% CI, 0.95-3.55), respectively. The OR for the overall (marginal) effect of receiving CBT (n = 552) vs no CBT (n = 535) was 1.71 (95% CI, 1.15-2.53) and for exercise (n = 531) vs no exercise (n = 556) was 1.07 (95% CI, 0.76-1.50). For secondary outcomes, exercise alone or in combination with CBT significantly improved fatigue, distress, cognitive symptoms, and mental health functioning, while CBT alone significantly improved cognitive symptoms and mental health functioning. Neither treatment had a significant impact on pain.
Conclusion Our results suggest that CBT and/or exercise can provide modest relief for some of the symptoms of chronic multisymptom illnesses such as GWVI.
Author Affiliations: VA Medical Center, Boston, Mass (Drs Donta, Sogg, Thakore, and Mori); University of Michigan Medical Center, Ann Arbor (Drs Clauw and Williams); Walter Reed Army Medical Center and Uniformed Services University, Bethesda, Md (Drs Engel and Smith); Cooperative Studies Program Coordinating Center (Mr Guarino and Dr Peduzzi), VA Connecticut Healthcare System (Dr Kerns), West Haven, Conn; Indiana University, Bloomington (Dr Skinner); Portland VA Medical Center and Oregon Health and Science University, Portland (Dr Barkhuizen); VA Medical and Regional Office Center, White River Junction, Vt (Dr Taylor); VA Medical Center, Bedford, Mass (Dr Kazis); VA Puget Sound Healthcare System, Seattle Division, Seattle, Wash (Drs Hunt, Dougherty, and Richardson); New Mexico VA Health Care System, Albuquerque (Drs Kunkel and Salisbury); San Juan VA Medical Center, San Juan, Puerto Rico (Drs Rodriguez and Alicea); Audie L. Murphy Memorial Veterans Hospital, San Antonio, Tex (Dr Chiliade); Naval Health Research Center, San Diego, Calif (Drs Ryan and Gray); New York Harbor VA Healthcare System, Brooklyn Campus, New York, NY (Drs Lutwick and Norwood); Birmingham VA Medical Center, Birmingham, Ala (Drs Everson and Blackburn); John Cochran VA Medical Center, St Louis, Mo (Dr Martin); San Francisco VA Medical Center, San Francisco, Calif (Dr Griffiss); Fargo VA Medical and Regional Office Center, Fargo, ND (Drs Cooper and Renner); H. H. McGuire VA Medical Center, Richmond, Va (Drs Schmitt and McMurtry); VA New Jersey Health Care System, East Orange (Dr Park); Philadelphia VA Medical Center, Philadelphia, Pa (Dr Pullman-Mooar); Dayton VA Medical Center, Dayton, Ohio (Drs Bernstein and Hershberger); and Medical University of South Carolina, Charleston (Dr Feussner).
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