TY - JOUR
T1 - Cognitive Behavioral Therapy and Aerobic Exercise for Gulf War Veterans' Illnesses
T2 - A Randomized Controlled Trial
AU - Donta, Sam T.
AU - Clauw, Daniel J.
AU - Engel, Charles C.
AU - Guarino, Peter
AU - Peduzzi, Peter
AU - Williams, David A.
AU - Skinner, James S.
AU - Barkhuizen, André
AU - Taylor, Thomas
AU - Kazis, Lewis E.
AU - Sogg, Stephanie
AU - Hunt, Stephen C.
AU - Dougherty, Cynthia M.
AU - Richardson, Ralph D.
AU - Kunkel, Charles
AU - Rodriguez, William
AU - Alicea, Edwin
AU - Chiliade, Philippe
AU - Ryan, Margaret
AU - Gray, Gregory C.
AU - Lutwick, Larry
AU - Norwood, Dorothy
AU - Smith, Samantha
AU - Everson, Michael
AU - Blackburn, Warren
AU - Martin, Wade
AU - Griffiss, J. Mc Leod
AU - Cooper, Robert
AU - Renner, Ed
AU - Schmitt, James
AU - McMurtry, Cynthia
AU - Thakore, Manisha
AU - Mori, Deanna
AU - Kerns, Robert
AU - Park, Maryann
AU - Pullman-Mooar, Sally
AU - Bernstein, Jack
AU - Hershberger, Paul
AU - Salisbury, Don C.
AU - Feussner, John R.
PY - 2003/3/19
Y1 - 2003/3/19
N2 - 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 × 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.
AB - 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 × 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.
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U2 - 10.1001/jama.289.11.1396
DO - 10.1001/jama.289.11.1396
M3 - Article
C2 - 12636462
AN - SCOPUS:0037454291
SN - 0098-7484
VL - 289
SP - 1396
EP - 1404
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
IS - 11
ER -