Rural Veterans With Post-traumatic Stress Disorder (PTSD) And Comorbid Mild Traumatic Brain Injury (TBI): A Feasibility Study
Remote Administration Of Cognitive Training Tasks In Rural Veterans With PTSD And Comorbid Mild TBI: A Feasibility Study
2 other identifiers
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 14, 2011
CompletedFirst Posted
Study publicly available on registry
January 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMarch 22, 2018
March 1, 2018
4 years
January 14, 2011
March 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Compliance rates
Compliance is defined as number of times per week and number of hours per day of task performance
Up to ten weeks
Qualitative assessment
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.
Up to ten weeks
Secondary Outcomes (2)
Improvement in performance over time
Up to ten weeks
Relation of performance to mental health
At ten weeks
Study Arms (2)
Cognitive training
EXPERIMENTALCognitive 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.
Control
ACTIVE COMPARATORThe control group will perform computerized tasks that utilize cognitive performance, but were not systematically developed to improve cognitive performance.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- years
- Normal or corrected to normal vision and hearing.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary R Newsome, PhD
Michael E. DeBakey VA Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
January 14, 2011
First Posted
January 17, 2011
Study Start
January 1, 2011
Primary Completion
January 1, 2015
Study Completion
May 1, 2015
Last Updated
March 22, 2018
Record last verified: 2018-03