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Exercise and Behavioral Therapy Trial (EBT).

25 juni 2015 bijgewerkt door: US Department of Veterans Affairs

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving

1064

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Puerto Rico
      • San Juan, Puerto Rico, 00921-3201
        • San Juan Vamc
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35233
        • Birmingham Vamc
      • Birmingham, Alabama, Verenigde Staten, 35233
        • Birmingham Vamc Birmingham Vamc
    • California
      • San Diego, California, Verenigde Staten, 92106-6000
        • Naval Health Research Center, San Diego
      • San Diego, California, Verenigde Staten, 92152
        • Naval Health Research Center, San Diego
      • San Diego, California, Verenigde Staten, 92186-5122
        • Naval Health Research Center, San Diego
      • San Francisco, California, Verenigde Staten, 94121
        • San Francisco VAMC
    • Connecticut
      • West Haven, Connecticut, Verenigde Staten, 06516
        • VA CT Healthcare System, West Haven
    • District of Columbia
      • Washington, District of Columbia, Verenigde Staten, 20007
        • Georgetown University Medical Center
      • Washington, District of Columbia, Verenigde Staten, 20307-5001
        • Walter Reed Army Medical Center
    • Maryland
      • Bethesda, Maryland, Verenigde Staten, 20814-4799
        • Uniformed Services University
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02118
        • Boston Medical Center
      • Boston, Massachusetts, Verenigde Staten, 02130
        • Boston Vamc
      • Boston, Massachusetts, Verenigde Staten, 02114
        • Boston Vamc
    • Missouri
      • St. Louis, Missouri, Verenigde Staten, 63106
        • John Cochran VAMC, Saint Louis
    • New Jersey
      • East Orange, New Jersey, Verenigde Staten, 07018
        • VA New Jersey Health Care System, East Orange
    • New Mexico
      • Albuquerque, New Mexico, Verenigde Staten, 87108
        • Vamc - Albuquerque
    • New York
      • Brooklyn, New York, Verenigde Staten, 11209
        • New York Harbor VA Healthcare System, Brooklyn Campus
    • North Dakota
      • Fargo, North Dakota, Verenigde Staten, 58102
        • Fargo Vamc
    • Ohio
      • Dayton, Ohio, Verenigde Staten, 45428
        • Vamc - Dayton
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97207
        • Portland Vamc
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • Philadelphia Vamc
    • Texas
      • Houston, Texas, Verenigde Staten, 77030
        • Houston VAMC
      • San Antonio, Texas, Verenigde Staten, 78284
        • Audie L. Murphy Memorial Veterans Hospital, San Antonio
    • Vermont
      • Burlington, Vermont, Verenigde Staten
        • White River Junction VAMC
      • White River Jct., Vermont, Verenigde Staten, 05009
        • White River Junction VAMC
    • Virginia
      • Richmond, Virginia, Verenigde Staten, 23249
        • Richmond VAMC
    • Washington
      • Seattle, Washington, Verenigde Staten, 98108-1597
        • VA Puget Sound Healthcare System, Seattle Division
      • Seattle, Washington, Verenigde Staten, 98108
        • VA Puget Sound Healthcare System, Seattle Division

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Faculteitstoewijzing
  • Masker: Geen (open label)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

US Department of Veterans Affairs

Medewerkers

United States Department of Defense

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 1999

Studie voltooiing

1 augustus 2001

Studieregistratiedata

Eerst ingediend

29 december 2000

Eerst ingediend dat voldeed aan de QC-criteria

30 december 2000

Eerst geplaatst (Schatting)

1 januari 2001

Updates van studierecords

Laatste update geplaatst (Schatting)

26 juni 2015

Laatste update ingediend die voldeed aan QC-criteria

25 juni 2015

Laatst geverifieerd

1 juni 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 470

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