NCT00129454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2005

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2008

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

2.5 years

First QC Date

August 9, 2005

Last Update Submit

June 2, 2017

Conditions

Gulf War Syndrome

Keywords

TelemedicineCognitive Behavior TherapyUtilizationRandomized Control TrialGulf War IllnessSymptom-Based IllnessMultisymptom IllnessHigh utilization

Outcome Measures

Primary Outcomes (1)

  • Frequency of medical visitation

    12 months

Secondary Outcomes (1)

  • quality of life

    12 months

Study Arms (3)

Telemedicine treatment

EXPERIMENTAL

Psychotherapy delivered by telephone

Behavioral: Cognitive Behavioral Therapy

In-Person treatment

ACTIVE COMPARATOR

Psychotherapy delivered in-person

Behavioral: Cognitive Behavioral Therapy

Assessment only

NO INTERVENTION

No intervention

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

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).

In-Person treatmentTelemedicine treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

East Orange, New Jersey, 07018, United States

Location

MeSH Terms

Conditions

Persian Gulf SyndromePatient Acceptance of Health Care

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Occupational DiseasesWar-Related InjuriesWounds and InjuriesTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mia M Downing, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2005

First Posted

August 11, 2005

Study Start

September 1, 2005

Primary Completion

February 22, 2008

Study Completion

March 1, 2008

Last Updated

June 6, 2017

Record last verified: 2017-06

Locations

US(1)