Telemedicine Treatment for Veterans With Gulf War Illness

Not Applicable

Completed

• Conditions: Gulf War Syndrome
• Interventions: Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT00129454
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2005-08-09
• Study First Submitted QC: 2005-08-09
• Study First Posted: 2005-08-11
• Study Start: 2005-09-01
• Primary Completion: 2008-02-22
• Study Completion: 2008-03-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-02
• Last Update Posted: 2017-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Telemedicine treatment	Cognitive Behavioral Therapy	Psychotherapy delivered by telephone
In-Person treatment	Cognitive Behavioral Therapy	Psychotherapy delivered in-person

Primary Outcome Measures

Name	Time	Method
Frequency of medical visitation	12 months

Secondary Outcome Measures

Name	Time	Method
quality of life	12 months

Trial Locations

Locations (1)

East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ; 🇺🇸 East Orange, New Jersey, United States