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Telemedicine Treatment for Veterans With Gulf War Illness

Primary Purpose

Gulf War Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Cognitive Behavioral Therapy
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gulf War Syndrome focused on measuring Telemedicine, Cognitive Behavior Therapy, Utilization, Randomized Control Trial, Gulf War Illness, Symptom-Based Illness, Multisymptom Illness, High utilization

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Telemedicine treatment

In-Person treatment

Assessment only

Arm Description

Psychotherapy delivered by telephone

Psychotherapy delivered in-person

No intervention

Outcomes

Primary Outcome Measures

Frequency of medical visitation

Secondary Outcome Measures

quality of life

Full Information

First Posted
August 9, 2005
Last Updated
June 2, 2017
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00129454
Brief Title
Telemedicine Treatment for Veterans With Gulf War Illness
Official Title
Telemedicine Treatment for Veterans With Gulf War Illness
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2005 (Actual)
Primary Completion Date
February 22, 2008 (Actual)
Study Completion Date
March 1, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gulf War Syndrome
Keywords
Telemedicine, Cognitive Behavior Therapy, Utilization, Randomized Control Trial, Gulf War Illness, Symptom-Based Illness, Multisymptom Illness, High utilization

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine treatment
Arm Type
Experimental
Arm Description
Psychotherapy delivered by telephone
Arm Title
In-Person treatment
Arm Type
Active Comparator
Arm Description
Psychotherapy delivered in-person
Arm Title
Assessment only
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
This description is the same as the experimental treatment only disseminated in person rather than over the telephone.
Primary Outcome Measure Information:
Title
Frequency of medical visitation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mia M Downing, PhD
Organizational Affiliation
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States

12. IPD Sharing Statement

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Telemedicine Treatment for Veterans With Gulf War Illness

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