Telemedicine Treatment for Veterans With Gulf War Illness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00129454
First received: August 9, 2005
Last updated: April 18, 2013
Last verified: October 2008
  Purpose

Effective treatments have been developed to ameliorate symptom-related distress and reduce unnecessary healthcare utilization using cognitive-behavioral techniques (CBT) . Despite convincing evidence of therapeutic efficacy, a major limitation of this treatment is that patients must attend sessions in person. The specific aims of the study are to: (1) Determine the clinical efficacy of Telephone CBT for veterans with GWI who are frequent consumers of ambulatory medical care; (2) Determine whether CBT for veterans with GWI leads to a reduction in the cost of VA health care; and (3) Develop a statistical model of treatment seeking in veterans with GWI who are frequent consumers of ambulatory medical care.


Condition Intervention
Gulf War Syndrome
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Telemedicine Treatment for Veterans With Gulf War Illness

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Frequency of medical visitation [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: September 2005
Study Completion Date: March 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 Behavioral: Cognitive Behavioral Therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Top 20% of medical care utilizers;
  • Satisfies criteria for multisymptom illness;
  • Enrolled in the New Jersey VA Healthcare System for at least one year

Exclusion Criteria:

  • Psychotic disorders;
  • Dementia or other cognitive disorders;
  • Brain damage;
  • Anorexia/other eating disorders;
  • Pregnancy;
  • Heart failure;
  • Cancer;
  • Chronic renal insufficiency;
  • Severe hepatic disease;
  • Active Substance Abuse/Dependence
  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: NCT00129454

Locations
United States, New Jersey
VA New Jersey Health Care System, East Orange
East Orange, New Jersey, United States, 07018
Sponsors and Collaborators
Investigators
Principal Investigator: Mia M Downing, PhD VA New Jersey Health Care System (East Orange)
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00129454     History of Changes
Other Study ID Numbers: GWI 04-355
Study First Received: August 9, 2005
Last Updated: April 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Telemedicine
Cognitive Behavior Therapy
Utilization
Randomized Control Trial
Gulf War Illness
Symptom-Based Illness
Multisymptom Illness
High utilization

Additional relevant MeSH terms:
Persian Gulf Syndrome
Occupational Diseases

ClinicalTrials.gov processed this record on September 29, 2014