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Rural Veterans With Post-traumatic Stress Disorder (PTSD) And Comorbid Mild Traumatic Brain Injury (TBI): A Feasibility Study

Not Applicable
Completed
Conditions
Post-Traumatic Stress Disorders
Traumatic Brain Injury
Interventions
Behavioral: Cognitive Training
Behavioral: Control
Registration Number
NCT01278316
Lead Sponsor
Michael E. DeBakey VA Medical Center
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Cognitive trainingCognitive TrainingCognitive Intervention Tasks Participants will be asked to perform the Brain Fitness (PositScience) cognitive training tasks an hour each day, five days per week for 8-10 weeks. Six tasks manipulating auditory and verbal information will be presented, and stimuli from all tasks are presented auditorily. All tasks are designed to begin with the lowest level of difficulty required to attain 85% accuracy, and as performance improves, difficulty increases to maintain 85% accuracy, with difficulty decreasing if accuracy decreases.
ControlControlThe control group will perform computerized tasks that utilize cognitive performance, but were not systematically developed to improve cognitive performance.
Primary Outcome Measures
NameTimeMethod
Compliance ratesUp to ten weeks

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

Qualitative assessmentUp 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 Outcome Measures
NameTimeMethod
Improvement in performance over timeUp to ten weeks

Performance at the beginning of the training session of each task will be compared to performance at the completion of the training session of each task.

Relation of performance to mental healthAt ten weeks

Scores on pre- and post- mental health measures will also be related to task performance

Trial Locations

Locations (1)

Michael E. DeBakey VA Medical Center

🇺🇸

Houston, Texas, United States

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