Exercise and Behavioral Therapy Trial (EBT).

CSP#470 - A Randomized, Multi-Center, Controlled Trial of Multi-Modal Therapy in Veterans With Gulf War Illnesses

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.

Study Overview

• Status: Completed
• Conditions: Persian Gulf Syndrome
• Intervention / Treatment: Behavioral: Cognitive behavioral therapy; Behavioral: Aerobic exercise

Detailed Description

Primary Hypothesis:

The primary hypothesis is that both aerobic exercise and cognitive behavioral therapy (CBT) will significantly improve physical function (as measured by the Physical Component Summary Scale of the SF-36V) in veterans with Gulf War Veterans' Illnesses (GWVI), and the combination of cognitive behavioral therapy and aerobic exercise will be more beneficial than either therapy alone.

Secondary Hypotheses:

1. Both aerobic exercise and CBT will lead to improvements in the cardinal symptoms of GWVI: pain, fatigue and cognitive difficulties.
2. Both aerobic exercise and CBT will lead to decreased levels of distress in persons with GWVI.
3. Both aerobic exercise and CBT will lead to improvements in emotional functioning in persons with GWVI.

Primary Outcomes: Improvement on the Physical Component Summary Scale of the SF-36V of more than 7 units at one year relative to baseline.

Interventions: Twelve one-hour weekly sessions of Cognitive behavioral therapy, aerobic exercise, the combination of the two therapies (12 one-hour sessions of CBT and 12 one-hour sessions of aerobic exercise) and a control group that receives usual and customary care.

Study Abstract: This trial was a study of Gulf War era veterans who have unexplained chronic medical symptoms such as pain, fatigue, and/or cognitive difficulties. All Gulf War veterans who were deployed to the South West Asia theater of operations between August 1990 and August 1991 were eligible for the study if they had at least two of the following three symptoms that began after August of 1990, lasting for more than six months and occurring up to present: 1. fatigue that limits usual activities (work, recreation, or social), 2. musculoskeletal pain involving two or more regions of the body, and neuro-cognitive dysfunction (self-reported difficulties in memory, concentration, or attention). Veterans who met enrollment criteria were randomized to one of four treatment arms: 1. CBT plus aerobic exercise, 2. aerobic exercise alone, 3. CBT alone, and 4. usual and customary care. Treatment was given for three months in group format. The CBT and exercise groups met for one hour, once a week for 12 weeks for a total of 12 hourly sessions. The interventions were standardized and all investigators were trained in the use of these methods prior to start up of the trial. The target sample size was 1064 veterans with GWVI to be accrued from 20 Medical Centers (18 VA and 2 DOD). All veterans were followed for one year and outcomes measured at 3 months (immediately following the end of treatment), 6 months and 12 months after enrollment.

The study was kicked-off in April 1999 and enrollment ended on September 5, 2000, during which 1092 veterans were randomized. Patient follow-up concluded on September 30, 2001 and the final DSMB meeting was held on November 28, 2001. The major finding was that there were no significant differences in the proportion of veterans who reported an improvement in physical function at one year among the treatment groups (11.5% for usual care, 11.7% for exercise, 18.4% for CBT and 18.5% for CBT + exercise). However, statistically significant improvements in fatigue, cognitive symptoms, distress, and mental health functioning were observed with exercise alone and with exercise plus CBT compared to usual care. CBT alone had a statistically significant effect on cognitive symptoms and in mental health functioning. Except for affective pain, which improved with CBT alone or with exercise, neither treatment had a significant effect on the other three measures of pain. In summary, neither exercise nor CBT had a significant impact on physical function for veterans with GWVI but both treatments, especially exercise, resulted in improvement in fatigue, cognitive symptoms, distress and mental health functioning.

Results embargoed until publication.

• Study Type: Interventional
• Enrollment: 1064
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00921-3201
    • San Juan Vamc
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Birmingham Vamc
    • Birmingham, Alabama, United States, 35233
      • Birmingham Vamc Birmingham Vamc
  • California
    • San Diego, California, United States, 92106-6000
      • Naval Health Research Center, San Diego
    • San Diego, California, United States, 92152
      • Naval Health Research Center, San Diego
    • San Diego, California, United States, 92186-5122
      • Naval Health Research Center, San Diego
    • San Francisco, California, United States, 94121
      • San Francisco VAMC
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • VA CT Healthcare System, West Haven
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Medical Center
    • Washington, District of Columbia, United States, 20307-5001
      • Walter Reed Army Medical Center
  • Maryland
    • Bethesda, Maryland, United States, 20814-4799
      • Uniformed Services University
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Boston, Massachusetts, United States, 02130
      • Boston Vamc
    • Boston, Massachusetts, United States, 02114
      • Boston Vamc
  • Missouri
    • St. Louis, Missouri, United States, 63106
      • John Cochran VAMC, Saint Louis
  • New Jersey
    • East Orange, New Jersey, United States, 07018
      • VA New Jersey Health Care System, East Orange
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Vamc - Albuquerque
  • New York
    • Brooklyn, New York, United States, 11209
      • New York Harbor VA Healthcare System, Brooklyn Campus
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • Fargo Vamc
  • Ohio
    • Dayton, Ohio, United States, 45428
      • Vamc - Dayton
  • Oregon
    • Portland, Oregon, United States, 97207
      • Portland Vamc
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia Vamc
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Vamc
    • San Antonio, Texas, United States, 78284
      • Audie L. Murphy Memorial Veterans Hospital, San Antonio
  • Vermont
    • Burlington, Vermont, United States
      • White River Junction VAMC
    • White River Jct., Vermont, United States, 05009
      • White River Junction VAMC
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Richmond VAMC
  • Washington
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start: March 1, 1999
• Study Completion: August 1, 2001

Study Registration Dates

• First Submitted: December 29, 2000
• First Submitted That Met QC Criteria: December 30, 2000
• First Posted (Estimate): January 1, 2001

Study Record Updates

• Last Update Posted (Estimate): June 26, 2015
• Last Update Submitted That Met QC Criteria: June 25, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: aerobic exercise; cognitive behavioral therapy; CBT; GWI; Gulf War Illnesses
• Additional Relevant MeSH Terms: Occupational Diseases; Persian Gulf Syndrome
• Other Study ID Numbers: 470