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NCT00007748 · ClinicalTrials.gov registry record · Phase 3

Exercise and Behavioral Therapy Trial (EBT).

A Phase 3 study, sponsored by US Department of Veterans Affairs.

Completed
Registry status
Phase 3
Development phase
1,064
Enrollment target

NCT00007748 is a Phase 3 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 1,064 participants.

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The verdict

NCT00007748, a Phase 3 study, has completed, sponsored by US Department of Veterans Affairs.

COMPLETED
Registry status
Phase 3
Development phase
1,064 participants
Enrollment target

Study Summary

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.

Interventions

  • BEHAVIORAL Aerobic exercise
  • BEHAVIORAL Cognitive behavioral therapy

Trial Details

FieldValue
Enrollment Target 1,064 participants
Start Date 1999-03
Est. Completion 2001-08
Phase Phase 3

Sponsor

US Department of Veterans Affairs

632 total trials

What the Registry Record Tells You About NCT00007748

The ClinicalTrials.gov registry entry for NCT00007748 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,064 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Aerobic exercise is the first listed.

NCT00007748 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00007748 about?

NCT00007748 is a clinical study titled "Exercise and Behavioral Therapy Trial (EBT).". 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 individua...

What is the current status of trial NCT00007748?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,064 participants. The study started on 1999-03. Estimated completion is 2001-08.

What interventions are being tested in trial NCT00007748?

The interventions under investigation include: Aerobic exercise (BEHAVIORAL), Cognitive behavioral therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT00007748?

This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.