N/A N=268 Randomized Double-blind Treatment

Cognitive Rehabilitation for Gulf War Illness

Gulf War Illness

Bottom Line

View on ClinicalTrials.gov: NCT02161133 ↗

Enrolled (actual)

268

Serious AEs

19.4%

Results posted

Jun 2020

Primary outcome: Primary: Disability - WHO-DAS 2 Change — -2.81; -2.21 score on a scale — p=0.712

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Problem-Solving Therapy (Behavioral); Health Education (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Disability - WHO-DAS 2 Change	-2.61; 1.11	0.057
SECONDARY Problem-Solving Inventory Change	-7.03; 0.26	0.013 sig
SECONDARY Problem-Solving Ability Change	13.81; 1.58	0.244
SECONDARY Disability - WHO-DAS 2 Change	-2.61; 1.11	0.057
SECONDARY Problem-Solving Inventory Change	-7.03; 0.26	0.013 sig

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02161133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.