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Completed

NCT Number: NCT01278316

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

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.

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Key information

Conditions

Post-Traumatic Stress Disorders Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Mental Disorders Nervous System Diseases Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control

Behavioral

Participants will be asked to perform computerized tasks that involve auditory and verbal performance one hour each day, five days per week for 8-10 weeks. Six tasks requiring auditory and verbal information will be presented.

Cognitive training

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  1. Improvement in performance over time

    Time frame: Up 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.

  2. Relation of performance to mental health

    Time frame: At ten weeks

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

Sponsors and collaborators

Lead sponsor

Michael E. DeBakey VA Medical Center

Fed

Collaborators

  • South Central VA Mental Illness Research, Education & Clinical Center

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 17, 2011
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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