ClinicalTrials.gov processed this data on March 29, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT00129454GWI 04-355NCT00129454Telemedicine Treatment for Veterans With Gulf War IllnessTelemedicine Treatment for Veterans With Gulf War IllnessVA Office of Research and DevelopmentU.S. FedNo
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.
CompletedSeptember 1, 2005March 1, 2008February 22, 2008N/AInterventionalNoRandomizedFactorial AssignmentOtherFrequency of medical visitation12 monthsquality of life12 months3128Gulf War SyndromeTelemedicine treatmentExperimentalPsychotherapy delivered by telephoneIn-Person treatmentActive ComparatorPsychotherapy delivered in-personAssessment onlyNo InterventionNo interventionBehavioralCognitive Behavioral TherapyThe 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).In-Person treatmentTelemedicine treatmentBehavioralCognitive Behavioral TherapyThis description is the same as the experimental treatment only disseminated in person rather than over the telephone.In-Person treatmentTelemedicine treatment
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
All18 Years70 YearsNoMia M Downing, PhDPrincipal InvestigatorEast Orange Campus of the VA New Jersey Health Care System, East Orange, NJEast Orange Campus of the VA New Jersey Health Care System, East Orange, NJEast OrangeNew Jersey07018United StatesUnited StatesJune 2017August 9, 2005August 9, 2005August 11, 2005June 2, 2017June 2, 2017June 6, 2017SponsorTelemedicineCognitive Behavior TherapyUtilizationRandomized Control TrialGulf War IllnessSymptom-Based IllnessMultisymptom IllnessHigh utilizationPersian Gulf Syndrome