Gulf War Syndrome Clinical Trial
Official title:
Telemedicine Treatment for Veterans With Gulf War Illness
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.
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.
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