Exercise and Behavioral Therapy Trial (EBT).

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00007748
First received: December 29, 2000
Last updated: April 25, 2008
Last verified: February 2003
  Purpose

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.


Condition Intervention Phase
Persian Gulf Syndrome
Behavioral: Aerobic exercise
Behavioral: Cognitive behavioral therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CSP#470 - A Randomized, Multi-Center, Controlled Trial of Multi-Modal Therapy in Veterans With Gulf War Illnesses

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 1064
Study Start Date: March 1999
Estimated Study Completion Date: August 2001
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007748

  Show 29 Study Locations
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00007748     History of Changes
Other Study ID Numbers: 470
Study First Received: December 29, 2000
Last Updated: April 25, 2008
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
aerobic exercise
cognitive behavioral therapy
CBT
Gulf War Illnesses
GWI

Additional relevant MeSH terms:
Persian Gulf Syndrome
Occupational Diseases

ClinicalTrials.gov processed this record on October 19, 2014