Clinical trial NCT02161133: Cognitive Rehabilitation for Gulf War Illness
Official title: Cognitive Rehabilitation for Gulf War Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gulf War Illness
Keywords: Veterans
neuropsychology
fatigue
Chronic Multisymptom Illness
Gulf War Illness
behavioral treatment
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-06-11
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disability - WHO-DAS 2 Change
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Problem-Solving Inventory Change
timeFrame: Baseline and 12 weeks
measure: Problem-Solving Ability Change
timeFrame: Baseline and 12 weeks
measure: Disability - WHO-DAS 2 Change
timeFrame: Baseline and 6 months
measure: Problem-Solving Inventory Change
timeFrame: Baseline and 6 months
Other outcomes:
measure: Pain Disability Change
timeFrame: Baseline and 12 weeks
measure: Multidimensional Pain Inventory - Pain Severity Subscale Change
timeFrame: baseline and 12 weeks
measure: Fatigue Change
timeFrame: Baseline and 12 weeks
Locations:
city: Bedford
country: United States
facility: Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
state: Massachusetts
city: East Orange
country: United States
facility: East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
state: New Jersey
city: Canandaigua
country: United States
facility: Canandaigua VA Medical Center, Canandaigua, NY
state: New York
Study officials:
affiliation: East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
name: Lisa M McAndrew, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sullivan N, Phillips LA, Pigeon WR, Quigley KS, Graff F, Litke DR, Helmer DA, Rath JF, McAndrew LM. Coping with Medically Unexplained Physical Symptoms: the Role of Illness Beliefs and Behaviors. Int J Behav Med. 2019 Dec;26(6):665-672. doi: 10.1007/s12529-019-09817-z.