Treatment
Project Summary

Title: A Randomized, Multi-Center, Controlled Trial of Multi-Model Therapy in Veterans with Gulf War Illnesses (EBT) (See also VA-62; formerly VA/DOD 1D)
Synopsis: This ongoing study is designed to determine whether or not cognitive behavioral therapy (CBT) and aerobic exercise, alone or in combination, are better than usual and customary care for Gulf War veterans with chronic unexplained symptoms.
Overall Project Objective: To determine if multi-modal therapy will significantly improve clinical outcomes in veterans with Gulf War Illnesses. The primary endpoint was the proportion of patients improved at one year relative to baseline on the PCS scale of the SF-36V.
Status/Results to Date: The kickoff meeting was held in April of 1999 and patient enrollment began in May 1999. The Data Monitoring Board met in July 1999. A total of 1,092 patients were enrolled in the study. The primary endpoint was obtained on over 90% of enrolled patients. The data have been analyzed and the results were presented to the Data Monitoring Board in November, 2001 and to the principal investigators in December, 2001. A manuscript of the primary outcome was submitted in early January, 2002.
Project:DoD-115
Agency:Department Of Defense
Location:VAMC West Haven/Multiple Sites
P.I. Name:Sam T. Donta, M.D.
Research Type:Clinical
Research Focus:Treatment
Focus Category:Treatment
Status:Ongoing
Study Start Date:March 01,1999
Estimated Completion Date:August 03,2001
Specific Aims: This clinical trial studied Gulf War veterans who have unexplained chronic medical symptoms such as pain, fatigue, and/or cognitive difficulties. Patients were randomized to one of four groups: 1) Cognitive Behavioral Therapy (CBT) plus aerobic exercise, 2) aerobic exercise alone, 3) CBT alone, and 4) usual and customary care. The primary outcome was a clinically meaningful improvement in the Physical Component Summary (PCS) scale of the SF-36V at one year relative to baseline.
Methodology: A cohort of 1,092 patients who satisfied an operational definition of Gulf War Illness were enrolled from 18 VA and 2 DoD medical centers over a 18-month period. All patients were followed for one year and outcomes were measured at 3 months (immediately following the end of treatment), 6 months and 12 months. Patients with more than a 7-point increase were used, instead of changes in the actual PCS scale, because it represents a significant improvement and, hence, was more clinically meaningful than just a change in value.
Most Recent Publications:

Guarino G, Peduzzi P, Donta ST, Engel CC, Clauw D, Williams D, Skinner JS, Barkhauzen A, Kazis LE, Feussner JR. A multicenter two by two factorial trial of cognitive behavioral therapy and aerobic exercise for Gulf War veterans' illnesses: design of a veterans affairs cooperative study (CSP #470). Control Clin Trials, 22(3):310-32. Jun 2001. Abstract

Donta ST, Clauw D, Engel CC, Guarino P, Peduzzi P, Williams D, Skinner JS, Barkhuizen A, Taylor T, Kazis LE, Sogg S, Hunt S, Dougherty C, Richardson RD, Kunkel C, Rodriguez W, Alicea E, Chiliade P, Ryan MA, Gray GC, Lutwick L, Norwood D, Smith S, Everson MP, Blackburn WD, Martin W, Griffiss M, Cooper R, Renner E, Schmitt J, McMurtry C, Thakore M, Mori D, Kerns R, Park M, Pullman-Mooar S, Bernstein J, Hershberger P, Salisbury D, Feussner JR. Cognitive Behavioral Therapy and Aerobic Exercise for Gulf War Veterans' Illnesses. A Randomized Controlled Trail. JAMA, 289(11):1396-1404. Mar 2003. Abstract

Skinner JS, Clauw D, Engel CC, Donta ST, Williams D, Barkhauzen A, Kazis LE, Sogg S, Guarino G, Peduzzi P, Feussner JR. Exercise testing in Gulf War veterans with chronic multisymptom illnesses: Comparison to physical functional status, and other self-report measures: Results from the VA Cooperative Study #470. Conference on Illnesses among Gulf War Veterans. A Decade of Scientific Research, 2001. Presentation

Engel CC, Williams D, Clauw D, Donta ST, Guarino G, Peduzzi P, Skinner JS, Barkhauzen A, Sogg S, Kazis LE, Feussner JR. Fatigue, pain, cognitive symptoms and mental health-related functioning among Gulf vets with chronic multisymptorn illnesses: Results from VA Cooperative Study #470. Conference on Illnesses among Gulf War Veterans. A Decade of Scientific Research, 2001. Presentation

Clauw D, Barkhauzen A, Engel CC, Donta ST, Williams D, Kazis LE, Sogg S, Guarino G, Peduzzi P, Skinner JS, Feussner JR. Measurement of tenderness in Gulf War veterans: what does it tell us? Arthritis Rheum, 44 (9 Suppl), Sep 2001. Article

Williams D, Engel CC, Clauw D, Donta ST, Barkhauzen A, Skinner JS, Kazis LE, Sogg S, Guarino G, Peduzzi P, Feussner JR. Physical functional status and its relationship to common symptoms of chronic multisymptom illnesses in Gulf War Veterans: Results from VA Cooperative Study #470. Conference on Illnesses among Gulf War Veterans. A Decade of Scientific Research, 2001. Presentation

Peduzzi P, Guarino G, Donta ST, Engel CC, Clauw D, Feussner JR. Research on informed consent: investigator-developed versus focus group-developed consent documents, a VA cooperative study. Control Clin Trials, 23(2):184-97, Apr 2002. Abstract