- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- Birmingham Vamc
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Birmingham, Alabama, Estados Unidos, 35233
- Birmingham Vamc Birmingham Vamc
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California
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San Diego, California, Estados Unidos, 92106-6000
- Naval Health Research Center, San Diego
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San Diego, California, Estados Unidos, 92152
- Naval Health Research Center, San Diego
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San Diego, California, Estados Unidos, 92186-5122
- Naval Health Research Center, San Diego
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San Francisco, California, Estados Unidos, 94121
- San Francisco VAMC
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Connecticut
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West Haven, Connecticut, Estados Unidos, 06516
- VA CT Healthcare System, West Haven
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20007
- Georgetown University Medical Center
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Washington, District of Columbia, Estados Unidos, 20307-5001
- Walter Reed Army Medical Center
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Maryland
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Bethesda, Maryland, Estados Unidos, 20814-4799
- Uniformed Services University
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Boston Medical Center
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Boston, Massachusetts, Estados Unidos, 02130
- Boston Vamc
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Boston, Massachusetts, Estados Unidos, 02114
- Boston Vamc
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Missouri
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St. Louis, Missouri, Estados Unidos, 63106
- John Cochran VAMC, Saint Louis
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New Jersey
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East Orange, New Jersey, Estados Unidos, 07018
- VA New Jersey Health Care System, East Orange
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87108
- Vamc - Albuquerque
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New York
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Brooklyn, New York, Estados Unidos, 11209
- New York Harbor VA Healthcare System, Brooklyn Campus
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58102
- Fargo Vamc
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Ohio
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Dayton, Ohio, Estados Unidos, 45428
- Vamc - Dayton
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Oregon
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Portland, Oregon, Estados Unidos, 97207
- Portland Vamc
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Philadelphia Vamc
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Texas
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Houston, Texas, Estados Unidos, 77030
- Houston Vamc
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San Antonio, Texas, Estados Unidos, 78284
- Audie L. Murphy Memorial Veterans Hospital, San Antonio
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Vermont
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Burlington, Vermont, Estados Unidos
- White River Junction VAMC
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White River Jct., Vermont, Estados Unidos, 05009
- White River Junction VAMC
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Virginia
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Richmond, Virginia, Estados Unidos, 23249
- Richmond VAMC
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Washington
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Seattle, Washington, Estados Unidos, 98108-1597
- VA Puget Sound Healthcare System, Seattle Division
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Seattle, Washington, Estados Unidos, 98108
- VA Puget Sound Healthcare System, Seattle Division
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San Juan, Porto Rico, 00921-3201
- San Juan Vamc
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Nenhum (rótulo aberto)
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 470
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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