Clinical trial NCT01278316: Rural Veterans With Post-traumatic Stress Disorder (PTSD) And Comorbid Mild Traumatic Brain Injury (TBI): A Feasibility Study
Official title: Remote Administration Of Cognitive Training Tasks In Rural Veterans With PTSD And Comorbid Mild TBI: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorders
Traumatic Brain Injury
Keywords: PTSD
TBI
Cognition
Cognitive Training
Lead sponsor: Michael E. DeBakey VA Medical Center
Sponsor class: FED
Collaborators: name: South Central VA Mental Illness Research, Education & Clinical Center
First posted: 2011-01-17
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Compliance rates
timeFrame: Up to ten weeks
measure: Qualitative assessment
timeFrame: Up to ten weeks
Secondary outcomes:
measure: Improvement in performance over time
timeFrame: Up to ten weeks
measure: Relation of performance to mental health
timeFrame: At ten weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center
name: Mary R Newsome, PhD
role: PRINCIPAL_INVESTIGATOR
References: