Exercise and Behavioral Therapy Trial (EBT).
CSP#470 - A Randomized, Multi-Center, Controlled Trial of Multi-Modal Therapy in Veterans With Gulf War Illnesses
研究概览
详细说明
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.
研究类型
注册
阶段
- 第三阶段
联系人和位置
学习地点
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San Juan、波多黎各、00921-3201
- San Juan Vamc
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Alabama
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Birmingham、Alabama、美国、35233
- Birmingham Vamc
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Birmingham、Alabama、美国、35233
- Birmingham Vamc Birmingham Vamc
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California
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San Diego、California、美国、92106-6000
- Naval Health Research Center, San Diego
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San Diego、California、美国、92152
- Naval Health Research Center, San Diego
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San Diego、California、美国、92186-5122
- Naval Health Research Center, San Diego
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San Francisco、California、美国、94121
- San Francisco VAMC
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Connecticut
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West Haven、Connecticut、美国、06516
- VA CT Healthcare System, West Haven
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District of Columbia
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Washington、District of Columbia、美国、20007
- Georgetown University Medical Center
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Washington、District of Columbia、美国、20307-5001
- Walter Reed Army Medical Center
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Maryland
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Bethesda、Maryland、美国、20814-4799
- Uniformed Services University
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Massachusetts
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Boston、Massachusetts、美国、02118
- Boston Medical Center
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Boston、Massachusetts、美国、02130
- Boston Vamc
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Boston、Massachusetts、美国、02114
- Boston Vamc
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Missouri
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St. Louis、Missouri、美国、63106
- John Cochran VAMC, Saint Louis
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New Jersey
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East Orange、New Jersey、美国、07018
- VA New Jersey Health Care System, East Orange
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New Mexico
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Albuquerque、New Mexico、美国、87108
- Vamc - Albuquerque
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New York
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Brooklyn、New York、美国、11209
- New York Harbor VA Healthcare System, Brooklyn Campus
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North Dakota
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Fargo、North Dakota、美国、58102
- Fargo Vamc
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Ohio
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Dayton、Ohio、美国、45428
- Vamc - Dayton
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Oregon
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Portland、Oregon、美国、97207
- Portland Vamc
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Philadelphia Vamc
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Texas
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Houston、Texas、美国、77030
- Houston Vamc
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San Antonio、Texas、美国、78284
- Audie L. Murphy Memorial Veterans Hospital, San Antonio
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Vermont
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Burlington、Vermont、美国
- White River Junction VAMC
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White River Jct.、Vermont、美国、05009
- White River Junction VAMC
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Virginia
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Richmond、Virginia、美国、23249
- Richmond VAMC
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Washington
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Seattle、Washington、美国、98108-1597
- VA Puget Sound Healthcare System, Seattle Division
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Seattle、Washington、美国、98108
- VA Puget Sound Healthcare System, Seattle Division
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:无(打开标签)
合作者和调查者
研究记录日期
研究主要日期
学习开始
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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