- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02161133
Cognitive Rehabilitation for Gulf War Illness
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Gulf War Illness (GWI) is a complex multi-dimensional illness which causes as much disability as other major medical diseases. Previous clinical trials (i.e. cognitive behavioral therapy and graded exercise) for GWI have sought to improve disability by increasing activity regardless of symptom presentation. These previous trials for GWI have shown limited efficacy and poor adherence. An innovative treatment approach is to target a specific component of GWI, namely problem-solving ability, known to be associated with disability.
Impairment in problem-solving ability affects Gulf War Veterans (GWV) with GWI and is prospectively related to greater risk of disability. This impairment is also related to poorer adherence to medical regimes, making it difficult for GWV to manage other aspects of GWI. Problem-solving is considered one of the most complex of cognitive abilities and is related to complicated behaviors such as setting goals, sequencing and multi-tasking. Despite published reports documenting these deficits there are no treatments that target the problem-solving deficits of GWI in order to reduce disability.
The investigators propose a targeted treatment, Problem-Solving Therapy, to compensate for the problem-solving deficits of GWI and thereby reducing disability. Problem-Solving Therapy, a top down approach, teaches patients skills to overcome problems like cognitive dysfunction or physical symptoms that impact problem-solving. Compensating for problem-solving deficits would reduce disability and provide information on the effect of treating one component of GWI on other symptoms of GWI. This is the first trial of cognitive rehabilitation therapy for GWI.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Bedford, Massachusetts, United States, 01730
- Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
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New Jersey
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East Orange, New Jersey, United States, 07018
- East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
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New York
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Canandaigua, New York, United States, 14424
- Canandaigua VA Medical Center, Canandaigua, NY
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Inclusion:
- deployed to first Gulf War and meets Kansas definition for GWI (see definition in measures section);
- scores at least a half a standard deviation worse than the mean on the World Health Organization Disability Schedule (WHO-DAS II).
Exclusion Criteria:
Exclusion:
- current suicidal/homicide intent or plan assessed by The Columbia Suicide Severity Rating Scale, schizophrenia or current psychotic symptoms
- self-reported diagnosis of a degenerative brain disorder or serious psychiatric or medical illness which may limit generalizability of the findings, limit safety or account for the symptoms of GWI.
Exclusionary medical illnesses include: Class 3 and 4 heart failure, cancer diagnosed within the past year and/or undergoing active treatment (chemotherapy or radiation therapy), chronic renal insufficiency, hospitalization due to myocardial infarct, stroke in the past year, a neurodegenerative disorder, or another medical or psychiatric disorder that may limit generalizability, limit participants safety or account for the symptoms of GWI at the discretion of the PI.
- a disability that would preclude telephone use.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Problem-Solving Therapy
Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems.
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Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems.
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Active Comparator: Health Education
Health education provides didactic information about Gulf War Illness
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Health Education provides didactic information about Gulf War Illness
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disability - WHO-DAS 2 Change
Time Frame: Baseline and 12 weeks
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World Health Organization Disability Assessment Schedule. The WHO-DAS 2.0 measures disability due to physical and mental health conditions. The WHO-DAS 2.0 is a 36 item measure that focuses upon six life tasks:
These six life tasks reflect two underlying constructs: Activity limitations and Participation deficits. Scores range from 0-100 with higher scores = more disability. |
Baseline and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Problem-Solving Inventory Change
Time Frame: Baseline and 12 weeks
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Self-report problem-solving ability.
Scores range from 32-192 with lower scores equally better problem-solving ability.
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Baseline and 12 weeks
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Problem-Solving Ability Change
Time Frame: Baseline and 12 weeks
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Neuropsychological Battery includes: Halstead Category Test, Russell Revised Version, The Conner's Continuous Performance Test-3 (CPT-3), Stroop Color and Word Test, Trails Making Test A and B (TMT).
Problem-solving ability was be created by standardizing (i.e., converting to z-scores) these neuropsychological tests based on administrative norms and averaging them.
The Z-score indicates the number of standard deviations away from the mean.
A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched).
Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population and higher scores reflecting greater problem solving.
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Baseline and 12 weeks
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Disability - WHO-DAS 2 Change
Time Frame: Baseline and 6 months
|
World Health Organization Disability Assessment Schedule. The WHO-DAS 2.0 measures disability due to physical and mental health conditions. The WHO-DAS 2.0 is a 36 item measure that focuses upon six life tasks:
These six life tasks reflect two underlying constructs: Activity limitations and Participation deficits. Scores range from 0-100 with higher scores = more disability. |
Baseline and 6 months
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Problem-Solving Inventory Change
Time Frame: Baseline and 6 months
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Self-report problem-solving ability.
Scores range from 32-192 with lower scores equally better problem-solving ability.
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Baseline and 6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Disability Change
Time Frame: Baseline and 12 weeks
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Pain Disability Index (PDI).
Scale ranges from 0-70 with higher scores meaning worse disability.
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Baseline and 12 weeks
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Multidimensional Pain Inventory - Pain Severity Subscale Change
Time Frame: baseline and 12 weeks
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three items assessing pain severity.
scores range 0-18 with higher scores=worse severity
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baseline and 12 weeks
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Fatigue Change
Time Frame: Baseline and 12 weeks
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The Fatigue Severity Scale (FSS).
Scale from 9 to 63 with higher scores = worse fatigue
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Baseline and 12 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Lisa M McAndrew, PhD, East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SPLD-009-13S
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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