Exercise and Behavioral Therapy Trial (EBT).

Persian Gulf Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00007748
• Other study ID #: 470
• Status: Completed
• Phase: Phase 3
• First received: December 29, 2000
• Last updated: June 25, 2015
• Start date: March 1999
• Est. completion date: August 2001

Study information

• Verified date: June 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1064
• Est. completion date: August 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Persian Gulf Syndrome

Intervention

Behavioral:
• Aerobic exercise

• Cognitive behavioral therapy

Locations

Country	Name	City	State
Puerto Rico	San Juan Vamc	San Juan
United States	Vamc - Albuquerque	Albuquerque	New Mexico
United States	Uniformed Services University	Bethesda	Maryland
United States	Birmingham Vamc	Birmingham	Alabama
United States	Birmingham Vamc Birmingham Vamc	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Boston Vamc	Boston	Massachusetts
United States	Boston Vamc	Boston	Massachusetts
United States	New York Harbor VA Healthcare System, Brooklyn Campus	Brooklyn	New York
United States	White River Junction Vamc	Burlington	Vermont
United States	Vamc - Dayton	Dayton	Ohio
United States	VA New Jersey Health Care System, East Orange	East Orange	New Jersey
United States	Fargo Vamc	Fargo	North Dakota
United States	Houston Vamc	Houston	Texas
United States	Philadelphia Vamc	Philadelphia	Pennsylvania
United States	Portland Vamc	Portland	Oregon
United States	Richmond Vamc	Richmond	Virginia
United States	Audie L. Murphy Memorial Veterans Hospital, San Antonio	San Antonio	Texas
United States	Naval Health Research Center, San Diego	San Diego	California
United States	Naval Health Research Center, San Diego	San Diego	California
United States	Naval Health Research Center, San Diego	San Diego	California
United States	San Francisco Vamc	San Francisco	California
United States	VA Puget Sound Healthcare System, Seattle Division	Seattle	Washington
United States	VA Puget Sound Healthcare System, Seattle Division	Seattle	Washington
United States	John Cochran VAMC, Saint Louis	St. Louis	Missouri
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	VA CT Healthcare System, West Haven	West Haven	Connecticut
United States	White River Junction Vamc	White River Jct.	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	United States Department of Defense

Countries where clinical trial is conducted

United States,  Puerto Rico,