Telemedicine Treatment for Veterans With Gulf War Illness

Gulf War Syndrome Clinical Trial

Official title:

Telemedicine Treatment for Veterans With Gulf War Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129454
• Other study ID #: GWI 04-355
• Status: Completed
• Phase: N/A
• First received: August 9, 2005
• Last updated: June 2, 2017
• Start date: September 1, 2005
• Est. completion date: March 1, 2008

Study information

• Verified date: June 2017
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 1, 2008
• Est. primary completion date: February 22, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gulf War Syndrome
• Persian Gulf Syndrome

Intervention

Behavioral:
• Cognitive Behavioral Therapy
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).
• Cognitive Behavioral Therapy
This description is the same as the experimental treatment only disseminated in person rather than over the telephone.

Locations

Country	Name	City	State
United States	East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ	East Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of medical visitation		12 months
Secondary	quality of life		12 months