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Clinical Trials/NCT01278316
NCT01278316
Completed
Not Applicable

Remote Administration Of Cognitive Training Tasks In Rural Veterans With PTSD And Comorbid Mild TBI: A Feasibility Study

Michael E. DeBakey VA Medical Center1 site in 1 country16 target enrollmentJanuary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-Traumatic Stress Disorders
Sponsor
Michael E. DeBakey VA Medical Center
Enrollment
16
Locations
1
Primary Endpoint
Compliance rates
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This study is being conducted to understand whether training in tasks that require perceiving and thinking about things, or cognition, can improve memory in veterans who have been exposed to a blast explosion and have TBI and PTSD. A primary goal of the study is to determine whether it is feasible for veterans who don't live close to a VA to perform this cognitive training at home.

Detailed Description

Many military personnel have experienced traumatic brain injury (TBI) and posttraumatic stress disorder (PTSD) as a result of the current Afghanistan and Iraq wars. TBI occurs when a sudden force causes the brain to move, causing damage to brain cells. PTSD is an anxiety disorder associated with serious traumatic events. Blast explosions can lead to TBI. People who experience TBI as a result of a blast injury are more likely to experience PTSD than people who have TBI not due to blast. TBI and PTSD may be associated with memory problems in some patients. Because therapy for PTSD sometimes requires learning new ways to think about things and making new responses, being able to remember the new information being learned is important. It is possible that improving memory may also improve PTSD treatment. This is a prospective study of Operation Enduring Freedom and Operation Iraqi Freedom (Afghanistan and Iraq wars; OEF/OIF) veterans who will undergo two neuropsychological and psychiatric assessments prior and subsequent to a cognitive training intervention. This is a feasibility study to ascertain whether OEF/OIF veterans diagnosed with mild TBI and comorbid PTSD and who live in rural locations will adhere to the schedule demands required of a computer-based cognitive training protocol.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
May 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mary Newsome

PI

Michael E. DeBakey VA Medical Center

Eligibility Criteria

Inclusion Criteria

  • Rural residence
  • Willingness to commit to the time requirements of the study
  • Undergoing treatment for posttraumatic stress disorder (PTSD) as assessed by a clinician, diagnosed with mild traumatic brain injury (TBI)
  • Native English speaker
  • 20-40 years
  • Normal or corrected to normal vision and hearing.

Exclusion Criteria

  • Substance dependence
  • Major depression with suicidal ideation
  • Psychotic disorder
  • History of neurological disorder other than mild traumatic brain injury (TBI) due to blast from Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) (i.e., Afghanistan and Iraq wars) deployment
  • History of known or suspected learning disorder.

Outcomes

Primary Outcomes

Compliance rates

Time Frame: Up to ten weeks

Compliance is defined as number of times per week and number of hours per day of task performance

Qualitative assessment

Time Frame: Up to ten weeks

Participants' reactions to the study will be gathered with Likert scale ratings of perceived problems of delivery, ease of program use, and perceived improvement of cognition. Open-ended responses to structured questions on likes and dislikes, suggestions for improvement, and overall satisfaction will also be implemented.

Secondary Outcomes

  • Improvement in performance over time(Up to ten weeks)
  • Relation of performance to mental health(At ten weeks)

Study Sites (1)

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