Cognitive Rehabilitation for Gulf War Illness

Gulf War Illness Clinical Trial

Official title:

Cognitive Rehabilitation for Gulf War Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161133
• Other study ID #: SPLD-009-13S
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: September 1, 2019

Study information

• Verified date: August 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are almost 700,000 Gulf War Veterans (GWV) with 25-30% suffering from a devastating multi-symptom illness coined Gulf War Illness (GWI). GWV with GWI report significant activity limitations and chronic cognitive problems consistent with problem-solving deficits. Problem-solving is considered the most complex of cognitive abilities and is what enables us to conduct complicated behaviors such as setting goals, sequencing and multi-tasking. As a result studies have found that problem-solving deficits are prospectively related to a greater risk of disability. Despite published reports documenting these problems there are no treatments that target the problem-solving deficits of GWI. This proposal seeks to determine whether Problem-Solving Therapy, a patient centered cognitive rehabilitation therapy, can reduce disability by compensating for problem-solving deficits.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: September 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gulf War Illness

Intervention

Behavioral:
• Problem-Solving Therapy
Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems.
• Health Education
Health Education provides didactic information about Gulf War Illness

Locations

Country	Name	City	State
United States	Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA	Bedford	Massachusetts
United States	Canandaigua VA Medical Center, Canandaigua, NY	Canandaigua	New York
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
Other	Pain Disability Change	Pain Disability Index (PDI). Scale ranges from 0-70 with higher scores meaning worse disability.	Baseline and 12 weeks
Other	Multidimensional Pain Inventory - Pain Severity Subscale Change	three items assessing pain severity. scores range 0-18 with higher scores=worse severity	baseline and 12 weeks
Other	Fatigue Change	The Fatigue Severity Scale (FSS). Scale from 9 to 63 with higher scores = worse fatigue	Baseline and 12 weeks
Primary	Disability - WHO-DAS 2 Change	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: Understanding and communicating; Self-care; Mobility (getting around); Interpersonal relationships (getting along with others); Work and household roles (life activities); Community and civic roles (participation); 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
Secondary	Problem-Solving Inventory Change	Self-report problem-solving ability. Scores range from 32-192 with lower scores equally better problem-solving ability.	Baseline and 12 weeks
Secondary	Problem-Solving Ability Change	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.	Baseline and 12 weeks
Secondary	Disability - WHO-DAS 2 Change	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: Understanding and communicating; Self-care; Mobility (getting around); Interpersonal relationships (getting along with others); Work and household roles (life activities); Community and civic roles (participation); 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
Secondary	Problem-Solving Inventory Change	Self-report problem-solving ability. Scores range from 32-192 with lower scores equally better problem-solving ability.	Baseline and 6 months