Cognitive Rehabilitation for Gulf War Illness

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2019-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mild TBI Assessment & Rehabilitation

NCT02920788

Brain Injuries, Traumatic

ACTIVE_NOT_RECRUITING NA

Telerehabilitation for OIF/OEF Returnees With Combat-Related Traumatic Brain Injury

NCT00676182

Traumatic Brain Injury Post-traumatic Stress Disorder

COMPLETED

Goal-oriented Telehealth Rehabilitation of Executive Functioning for Veterans With Chronic TBI

NCT07190365

Mild to Moderate Traumatic Brain Injury Cognitive Rehabilitation Veteran

NOT_YET_RECRUITING NA

Evaluation of the Veterans' In-home Program

NCT01831830

Traumatic Brain Injury

COMPLETED NA

Validation of Cognitive Enhancement Techniques for Mild Traumatic Brain Injury

NCT04245124

Mild Traumatic Brain Injury

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gulf War Illness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Problem-Solving Therapy

Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems.

Group Type EXPERIMENTAL

Problem-Solving Therapy

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

Health Education provides didactic information about Gulf War Illness

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Problem-Solving Therapy

Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems.

Intervention Type BEHAVIORAL

Health Education

Health Education provides didactic information about Gulf War Illness

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No