Cognitive Rehabilitation for Gulf War Illness

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Gulf War Illness

Clinical Trial Details

NCT number	NCT02161133
Study type	Interventional
Source	VA Office of Research and Development
Contact
Status	Completed
Phase	N/A
Start date	January 1, 2015
Completion date	September 1, 2019

View Details

See also
Status	Clinical Trial	Phase
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Terminated	`NCT02011542` - Probiotic (VSL #3) for Gulf War Illness	Phase 2/Phase 3
Recruiting	`NCT03078530` - Probiotic (Visbiome) for Gulf War Illness	Phase 2/Phase 3
Recruiting	`NCT04058275` - "Immunomodulation in GWI (Phlebotomy)"
Recruiting	`NCT04255498` - Understanding GWI: Integrative Modeling	Phase 1
Completed	`NCT02782780` - Cognitive Behavioral Therapy for Insomnia for Gulf War Illness	N/A
Recruiting	`NCT02983734` - D-cycloserine: A Novel Treatment for Gulf War Illness (GWDCS)	Phase 2
Recruiting	`NCT05972291` - Mechanisms of Gulf War Illness	N/A
Recruiting	`NCT04182659` - Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms	N/A
Recruiting	`NCT04046536` - rTMS in Alleviating Pain and Co-Morbid Symptoms in Gulf War Veterans Illness (GWVI)	N/A
Recruiting	`NCT05377242` - Curcumin, Resveratrol, and Stinging Nettle as Treatments for GWI	N/A
Recruiting	`NCT05675878` - Confirmation of Diet as a Treatment for Gulf War Illness	Phase 3
Recruiting	`NCT05736146` - Validating Gulf War Illness Blood Biomarkers
Not yet recruiting	`NCT05820893` - Resistant Potato Starch to Alleviate GWI	Phase 2
Terminated	`NCT01846182` - Research Examining Gulf War Illness in Our Nations Service Members	Phase 2
Active, not recruiting	`NCT05252949` - OEA for Targeting Lipid Metabolism in GWI	N/A
Completed	`NCT02378025` - Treating Chronic Pain in Gulf War Illness	N/A
Completed	`NCT02865460` - Coenzyme Q10 Phase III Trial in Gulf War Illness	Phase 3
Completed	`NCT02909686` - Effects of Botanical Microglia Modulators in Gulf War Illness	N/A
Completed	`NCT01291758` - Exercise in Gulf War Illness (GWI)

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.