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Telemedicine Treatment for Veterans With Gulf War Illness

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00129454
First Posted: August 11, 2005
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
Effective treatments have been developed to ameliorate symptom-related distress and reduce unnecessary healthcare utilization using cognitive-behavioral techniques (CBT) . However there is 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
Intervention Model: Factorial Assignment
Primary Purpose: Other
Official Title: Telemedicine Treatment for Veterans With Gulf War Illness

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Frequency of medical visitation [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: 12 months ]

Enrollment: 128
Actual Study Start Date: September 1, 2005
Study Completion Date: March 1, 2008
Primary Completion Date: February 22, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telemedicine treatment
Psychotherapy delivered by telephone
Behavioral: Cognitive Behavioral Therapy
The investigators adapted two previously validated CBT manuals for use in both Telephone and In-Person groups (the "Personal Health Improvement Program" and Dr. Charles Engel's group treatment for GWI). Treatment included the following standard components of CBT: Didactic or educational material about the causes of GWI and an explanation of how thinking can cause stress ("ABC" model); Assessment of psychological distress and behavioral problems that may be targets of therapeutic intervention (e.g. symptom-related anxiety); Assessment of "thinking errors" that lead to psychological distress and trigger behavioral problems (e.g. catastrophizing); Cognitive restructuring to teach disputing skills or how to correct thinking errors; Cognitive and behavioral homework assignments (e.g. written self-disclosure); Didactic homework assignments (e.g. listen to previous treatment session).
Behavioral: Cognitive Behavioral Therapy
This description is the same as the experimental treatment only disseminated in person rather than over the telephone.
Active Comparator: In-Person treatment
Psychotherapy delivered in-person
Behavioral: Cognitive Behavioral Therapy
The investigators adapted two previously validated CBT manuals for use in both Telephone and In-Person groups (the "Personal Health Improvement Program" and Dr. Charles Engel's group treatment for GWI). Treatment included the following standard components of CBT: Didactic or educational material about the causes of GWI and an explanation of how thinking can cause stress ("ABC" model); Assessment of psychological distress and behavioral problems that may be targets of therapeutic intervention (e.g. symptom-related anxiety); Assessment of "thinking errors" that lead to psychological distress and trigger behavioral problems (e.g. catastrophizing); Cognitive restructuring to teach disputing skills or how to correct thinking errors; Cognitive and behavioral homework assignments (e.g. written self-disclosure); Didactic homework assignments (e.g. listen to previous treatment session).
Behavioral: Cognitive Behavioral Therapy
This description is the same as the experimental treatment only disseminated in person rather than over the telephone.
No Intervention: Assessment only
No intervention

Detailed Description:

At least as far back as the American Civil War, soldiers have reported nonspecific ailments that could not be attributed to an underlying medical cause. The most frequent symptoms include persistent fatigue, palpitations, headache, muscle or joint pain, disturbed sleep, and cognitive difficulties. Recent epidemiologic studies suggest that war-related syndromes are exceptionally common in deployed personnel and may affect 45% to 60% of returning soldiers. These post-deployment symptoms have substantial consequences that include increased medical visitation, increased physical disability, and increased psychological distress. The number of veterans at risk is likely to increase rather than decrease in the years ahead. In order to address this anticipated increase, new and more efficient treatments for symptom-based illness are urgently needed to augment or replace standard VA care. An effective treatment using cognitive-behavioral techniques (CBT) has been developed to ameliorate symptom-related distress and reduce unnecessary healthcare utilization. Despite convincing evidence of therapeutic efficacy, a major limitation of this treatment is that patients must attend sessions in person. This requirement may undermine the effectiveness of CBT since fewer than half of those who need treatment will attend. A recent trial of CBT for veterans with Gulf War Illness found that only 38% were treatment adherent. Any sudden increase in the number of veterans seeking care could overwhelm the limited resources of a local VA healthcare center. The proposed study will address this important public health problem by testing a cost-effective and innovative strategy for delivering CBT over the phone.

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.

Participation is limited to veterans who satisfy a validated case definition of GWI and whose utilization is at (or above) the 80th percentile. A long-term goal of the proposed research is to make specialized Telephone CBT services widely available to veterans regardless of their geographic location. A previously validated CBT program for GWI has been adapted in consultation with Dr. Charles Engel. The proposed study represents the first randomized (multicenter) trial of Telephone CBT designed to ameliorate GWI and reduce unnecessary reliance on VA health care services. A total of 150 eligible veterans will be assigned to one of three groups: (I) Telephone CBT + Customary Medical Care; (II) In-Person CBT + Customary Medical Care; or (III) Customary Medical Care only.

Revised study procedures were developed and approved by our local IRB. CBT manual was refined and adapted for telephone use. Two postdoctoral fellows were recruited, trained in CBT, and study assessment techniques. A large pool of high utilizing veterans was identified. Of the first 1000 veteran names, 523 were not viable after chart review (outside catchment area; medical rule out; moved; deceased; etc); of 477 remaining 147 were not reachable; 102 declined; 46 were deemed ineligible after initial screening; 49 were eligible and scheduled for psychiatric interview. As of December 2006 a total of 116 veterans have been enrolled in the study and randomized to treatment.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129454


Locations
United States, New Jersey
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
East Orange, New Jersey, United States, 07018
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Mia M Downing, PhD East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00129454     History of Changes
Other Study ID Numbers: GWI 04-355
First Submitted: August 9, 2005
First Posted: August 11, 2005
Last Update Posted: June 6, 2017
Last Verified: June 2017

Keywords provided by VA Office of Research and Development:
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