Clinical trial NCT00007748: Exercise and Behavioral Therapy Trial (EBT).
Official title: CSP#470 - A Randomized, Multi-Center, Controlled Trial of Multi-Modal Therapy in Veterans With Gulf War Illnesses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Persian Gulf Syndrome
Keywords: aerobic exercise
cognitive behavioral therapy
CBT
Gulf War Illnesses
GWI
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: United States Department of Defense
First posted: 2001-01-01
Enrollment: 1064
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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).

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