Numerous studies have shown that poorly defined medical conditions, such as Gulf War Illness (GWI), are commonly reported in the aftermath of military conflict. 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 of GWI 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 with GWI diagnosed in 45% to 60% of returning soldiers. Despite an uncertain etiology, GWI has substantial consequences that include increased medical visitation, increased physical disability, and increased psychological distress. The fact that America is now engaged in military conflict abroad and threatened with weapons of mass destruction at home raises the possibility that a large number of veterans (and civilians) may eventually develop similar war-related illness. Unfortunately, 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 GWI are urgently needed to augment or replace standard VA care. Fortunately, 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 clinical effectiveness of CBT since fewer than half of those who need treatment are likely to attend. A recent trial of CBT for veterans with GWI 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.

Condition	Intervention
High utilization	Behavior: Cognitive Behavioral Therapy

Further Study Details: 

Primary Outcomes: Frequency of medical visitation
Secondary Outcomes: quality of life
Expected Total Enrollment:  150

Background:

Numerous studies have shown that poorly defined medical conditions, such as Gulf War Illness (GWI), are commonly reported in the aftermath of military conflict. 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 of GWI 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 with GWI diagnosed in 45% to 60% of returning soldiers. Despite an uncertain etiology, GWI has substantial consequences that include increased medical visitation, increased physical disability, and increased psychological distress. The fact that America is now engaged in military conflict abroad and threatened with weapons of mass destruction at home raises the possibility that a large number of veterans (and civilians) may eventually develop similar war-related illness. Unfortunately, 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 GWI are urgently needed to augment or replace standard VA care. Fortunately, 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 clinical effectiveness of CBT since fewer than half of those who need treatment are likely to attend. A recent trial of CBT for veterans with GWI 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.

Objectives:

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.

Methods:

Participation will be 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 will be adapted in consultation with Dr. Charles Engel who participated in the largest trial to date of CBT for military personnel. The proposed study will be 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.

Findings:

No results at this time.

Status:

Eligible participants utilizing VA primary care services at the 80th percentile or above have been identified. A modified CBT manual is under development and project staff are being hired.

Impact:

Given the prevalence of GWI and the likelihood that many of these individuals may seek VA services for medically unexplained illness, there is an urgent need to develop and test more cost effective methods of reducing unnecessary utilization. The development of a telephone intervention may

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00129454

New Jersey
      VA New Jersey Health Care System, East Orange, East Orange,  New Jersey,  07018,  United States

Study chairs or principal investigators

Donald S. Ciccone, PhD,  Principal Investigator,  VA New Jersey Health Care System, East Orange   

Study ID Numbers:  GWI 04-355
Last Updated:  August 10, 2005
Record first received:  August 9, 2005
ClinicalTrials.gov Identifier:  NCT00129454
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23