- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00007748
Exercise and Behavioral Therapy Trial (EBT).
CSP#470 - A Randomized, Multi-Center, Controlled Trial of Multi-Modal Therapy in Veterans With Gulf War Illnesses
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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:
- Both aerobic exercise and CBT will lead to improvements in the cardinal symptoms of GWVI: pain, fatigue and cognitive difficulties.
- Both aerobic exercise and CBT will lead to decreased levels of distress in persons with GWVI.
- 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.
Studietyp
Inskrivning
Fas
- Fas 3
Kontakter och platser
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35233
- Birmingham Vamc
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Birmingham, Alabama, Förenta staterna, 35233
- Birmingham Vamc Birmingham Vamc
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California
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San Diego, California, Förenta staterna, 92106-6000
- Naval Health Research Center, San Diego
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San Diego, California, Förenta staterna, 92152
- Naval Health Research Center, San Diego
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San Diego, California, Förenta staterna, 92186-5122
- Naval Health Research Center, San Diego
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San Francisco, California, Förenta staterna, 94121
- San Francisco VAMC
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Connecticut
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West Haven, Connecticut, Förenta staterna, 06516
- VA CT Healthcare System, West Haven
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 20007
- Georgetown University Medical Center
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Washington, District of Columbia, Förenta staterna, 20307-5001
- Walter Reed Army Medical Center
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Maryland
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Bethesda, Maryland, Förenta staterna, 20814-4799
- Uniformed Services University
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02118
- Boston Medical Center
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Boston, Massachusetts, Förenta staterna, 02130
- Boston Vamc
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Boston, Massachusetts, Förenta staterna, 02114
- Boston Vamc
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Missouri
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St. Louis, Missouri, Förenta staterna, 63106
- John Cochran VAMC, Saint Louis
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New Jersey
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East Orange, New Jersey, Förenta staterna, 07018
- VA New Jersey Health Care System, East Orange
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87108
- Vamc - Albuquerque
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New York
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Brooklyn, New York, Förenta staterna, 11209
- New York Harbor VA Healthcare System, Brooklyn Campus
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North Dakota
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Fargo, North Dakota, Förenta staterna, 58102
- Fargo Vamc
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Ohio
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Dayton, Ohio, Förenta staterna, 45428
- Vamc - Dayton
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Oregon
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Portland, Oregon, Förenta staterna, 97207
- Portland Vamc
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Philadelphia Vamc
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Texas
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Houston, Texas, Förenta staterna, 77030
- Houston Vamc
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San Antonio, Texas, Förenta staterna, 78284
- Audie L. Murphy Memorial Veterans Hospital, San Antonio
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Vermont
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Burlington, Vermont, Förenta staterna
- White River Junction VAMC
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White River Jct., Vermont, Förenta staterna, 05009
- White River Junction VAMC
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Virginia
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Richmond, Virginia, Förenta staterna, 23249
- Richmond VAMC
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Washington
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Seattle, Washington, Förenta staterna, 98108-1597
- VA Puget Sound Healthcare System, Seattle Division
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Seattle, Washington, Förenta staterna, 98108
- VA Puget Sound Healthcare System, Seattle Division
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San Juan, Puerto Rico, 00921-3201
- San Juan Vamc
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Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
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Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 470
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