AzTrials
AzTrials

Gulf War SyndromeNCT00129454

Telemedicine Treatment for Veterans With Gulf War Illness

A study testing Cognitive Behavioral Therapy in people with Gulf War Syndrome, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gulf War Syndrome
What is being tested?
Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteUnited States
Study dates
1 Sep 2005to 1 Mar 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Top 20% of medical care utilizers;
  • Satisfies criteria for multisymptom illness;
  • Enrolled in the New Jersey VA Healthcare System for at least one year

Who cannot join

  • Psychotic disorders;
  • Dementia or other cognitive disorders;
  • Brain damage;
  • Anorexia/other eating disorders;
  • Pregnancy;
  • Heart failure;
Show all 10Show fewer
  • Cancer;
  • Chronic renal insufficiency;
  • Severe hepatic disease;
  • Active Substance Abuse/Dependence

Trial locations and contacts

1 site in 1 country.

United States1 site
  • East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

    East Orange, New Jersey, 07018

Other trials in United States

About this study

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.

Read the 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.

Keywords
Telemedicine, Cognitive Behavior Therapy, Utilization, Randomized Control Trial, Gulf War Illness, Symptom-Based Illness, Multisymptom Illness, High utilization
Medical subject headings
Persian Gulf Syndrome, Patient Acceptance of Health Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral TherapyBehavioural

    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 TherapyBehavioural

    This description is the same as the experimental treatment only disseminated in person rather than over the telephone.

Study groups in NCT00129454
Study groupRoleWhat they receive
Telemedicine treatmentExperimentalPsychotherapy delivered by telephone
Receives: Behavioral: Cognitive Behavioral Therapy
In-Person treatmentActive comparatorPsychotherapy delivered in-person
Receives: Behavioral: Cognitive Behavioral Therapy
Assessment onlyNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of medical visitation

    Measured: 12 months

Secondary outcomes (1)
  1. quality of life

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2005 (estimated)
  2. Study start1 Sep 2005
  3. Primary completion22 Feb 2008
  4. Study completion1 Mar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00129454
Sponsor's protocol ID
GWI 04-355
Status last verified
Jun 2017
First submitted
9 Aug 2005
Last updated
6 Jun 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy in people with Gulf War Syndrome, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of medical visitation (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in