Rural Veterans With Post-traumatic Stress Disorder (PTSD) And Comorbid Mild Traumatic Brain Injury (TBI): A Feasibility Study
|ClinicalTrials.gov Identifier: NCT01278316|
Recruitment Status : Unknown
Verified July 2014 by Mary Newsome, Michael Debakey Veterans Affairs Medical Center.
Recruitment status was: Active, not recruiting
First Posted : January 17, 2011
Last Update Posted : July 18, 2014
|Condition or disease||Intervention/treatment|
|Post-Traumatic Stress Disorders Traumatic Brain Injury||Behavioral: Control Behavioral: Cognitive Training|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Remote Administration Of Cognitive Training Tasks In Rural Veterans With PTSD And Comorbid Mild TBI: A Feasibility Study|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||May 2015|
Experimental: Cognitive training
Cognitive 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.
Behavioral: Cognitive Training
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.
Active Comparator: Control
The control group will perform computerized tasks that utilize cognitive performance, but were not systematically developed to improve cognitive performance.
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.
- 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.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278316
|United States, Texas|
|Michael E. DeBakey VA Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Mary R Newsome, PhD||Michael E. DeBakey VA Medical Center|