Clinical Trials Directory

Trials / Completed

CompletedNCT02161133

Cognitive Rehabilitation for Gulf War Illness

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
268 (actual)
Sponsor
VA Office of Research and Development · Federal
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALProblem-Solving TherapyProblem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems.
BEHAVIORALHealth EducationHealth Education provides didactic information about Gulf War Illness

Timeline

Start date
2015-01-01
Primary completion
2018-12-31
Completion
2019-09-01
First posted
2014-06-11
Last updated
2020-08-26
Results posted
2020-06-04

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02161133. Inclusion in this directory is not an endorsement.