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Exercise and Behavioral Therapy Trial (EBT).

2015년 6월 25일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록

1064

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 요인 할당
  • 마스킹: 없음(오픈 라벨)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

US Department of Veterans Affairs

협력자

United States Department of Defense

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

1999년 3월 1일

연구 완료

2001년 8월 1일

연구 등록 날짜

최초 제출

2000년 12월 29일

QC 기준을 충족하는 최초 제출

2000년 12월 30일

처음 게시됨 (추정)

2001년 1월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 6월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 6월 25일

마지막으로 확인됨

2015년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 470

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