- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
Alabama
-
Birmingham, Alabama, Forente stater, 35233
- Birmingham Vamc
-
Birmingham, Alabama, Forente stater, 35233
- Birmingham Vamc Birmingham Vamc
-
-
California
-
San Diego, California, Forente stater, 92106-6000
- Naval Health Research Center, San Diego
-
San Diego, California, Forente stater, 92152
- Naval Health Research Center, San Diego
-
San Diego, California, Forente stater, 92186-5122
- Naval Health Research Center, San Diego
-
San Francisco, California, Forente stater, 94121
- San Francisco VAMC
-
-
Connecticut
-
West Haven, Connecticut, Forente stater, 06516
- VA CT Healthcare System, West Haven
-
-
District of Columbia
-
Washington, District of Columbia, Forente stater, 20007
- Georgetown University Medical Center
-
Washington, District of Columbia, Forente stater, 20307-5001
- Walter Reed Army Medical Center
-
-
Maryland
-
Bethesda, Maryland, Forente stater, 20814-4799
- Uniformed Services University
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02118
- Boston Medical Center
-
Boston, Massachusetts, Forente stater, 02130
- Boston Vamc
-
Boston, Massachusetts, Forente stater, 02114
- Boston Vamc
-
-
Missouri
-
St. Louis, Missouri, Forente stater, 63106
- John Cochran VAMC, Saint Louis
-
-
New Jersey
-
East Orange, New Jersey, Forente stater, 07018
- VA New Jersey Health Care System, East Orange
-
-
New Mexico
-
Albuquerque, New Mexico, Forente stater, 87108
- Vamc - Albuquerque
-
-
New York
-
Brooklyn, New York, Forente stater, 11209
- New York Harbor VA Healthcare System, Brooklyn Campus
-
-
North Dakota
-
Fargo, North Dakota, Forente stater, 58102
- Fargo Vamc
-
-
Ohio
-
Dayton, Ohio, Forente stater, 45428
- Vamc - Dayton
-
-
Oregon
-
Portland, Oregon, Forente stater, 97207
- Portland Vamc
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19104
- Philadelphia Vamc
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- Houston Vamc
-
San Antonio, Texas, Forente stater, 78284
- Audie L. Murphy Memorial Veterans Hospital, San Antonio
-
-
Vermont
-
Burlington, Vermont, Forente stater
- White River Junction VAMC
-
White River Jct., Vermont, Forente stater, 05009
- White River Junction VAMC
-
-
Virginia
-
Richmond, Virginia, Forente stater, 23249
- Richmond VAMC
-
-
Washington
-
Seattle, Washington, Forente stater, 98108-1597
- VA Puget Sound Healthcare System, Seattle Division
-
Seattle, Washington, Forente stater, 98108
- VA Puget Sound Healthcare System, Seattle Division
-
-
-
-
-
San Juan, Puerto Rico, 00921-3201
- San Juan Vamc
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Ingen (Open Label)
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 470
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Persian Gulf Syndrome
-
University of UtahVA Salt Lake City Health Care SystemTilbaketrukket
-
US Department of Veterans AffairsFullført
-
New England School of AcupunctureUnited States Department of DefenseFullført
-
Georgetown UniversityU.S. Army Medical Research and Development CommandFullførtGulfkrigssykdom | Persian Gulf War SyndromeForente stater
-
University of Alabama at BirminghamCongressionally Directed Medical Research ProgramsRekruttering
-
Baylor College of MedicineMichael E. DeBakey VA Medical CenterAvsluttet
-
The University of Texas at DallasUnited States Department of Defense; University of Texas Southwestern Medical...AvsluttetGulfkrigssyndromForente stater
-
American UniversityGeorgetown University; United States Department of DefenseFullført
-
South Florida Veterans Affairs Foundation for Research...United States Department of Defense; Nova Southeastern UniversityUkjentYrkessykdommer | Persian Gulf Syndrome | GulfkrigssykdomForente stater
-
South Florida Veterans Affairs Foundation for Research...Ukjent
Kliniske studier på Kognitiv atferdsterapi
-
Medical University of South CarolinaNational Institutes of Health (NIH)Påmelding etter invitasjonDepresjon | Depressive symptomerForente stater
-
Medical University of South CarolinaRekrutteringDepresjon | Kreft | Depressive symptomerForente stater
-
Nemours Children's ClinicFullførtDiabetes mellitus, type 2 | BarnefedmeForente stater
-
Nemours Children's ClinicFullførtDiabetes mellitus, type 2 | BarnefedmeForente stater
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA); National Institutes of Health...FullførtDepresjon | Depressive symptomer | UngdomsadferdForente stater
-
Medical University of South CarolinaDrug Abuse Research Training ProgramFullført
-
Hacettepe UniversityPåmelding etter invitasjonMotorisk aktivitet | Eksekutiv dysfunksjon | Kognitiv orienteringTyrkia
-
VA Office of Research and DevelopmentFullført
-
Texas Tech UniversityHar ikke rekruttert ennåSorg | Psykisk helseproblem | Byrde, omsorgspersonForente stater
-
Imperial College LondonNHS England (NHSE/I) LondonFullført