Telemedicine Treatment for Veterans With Gulf War Illness
Condition: Gulf War Syndrome
MeSH terms: Persian Gulf Syndrome
Study type: Interventional

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.
    

Intervention name(s): Cognitive Behavioral Therapy; Cognitive Behavioral Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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).; This description is the same as the experimental treatment only disseminated in person rather than over the telephone.
Allocation: Randomized
Intervention model: Factorial Assignment
Primary purpose: Other
Keywords: Telemedicine; Cognitive Behavior Therapy; Utilization; Randomized Control Trial; Gulf War Illness; Symptom-Based Illness; Multisymptom Illness; High utilization