Virtual Reality Therapy and Imaging in Combat Veterans With Blast Injury and Posttraumatic Stress Disorder (ViRTICo-BP)
|ClinicalTrials.gov Identifier: NCT01990547|
Recruitment Status : Completed
First Posted : November 21, 2013
Last Update Posted : February 10, 2016
|Condition or disease|
|Post-Traumatic Stress Disorder Blast Injury|
|Study Type :||Observational|
|Estimated Enrollment :||88 participants|
|Official Title:||The ViRTICo-BP Trials: Virtual Reality Therapy and Imaging in Combat Veterans With Blast Injury and Posttraumatic Stress Disorder|
|Primary Completion Date :||July 2014|
|Study Completion Date :||August 2014|
Healthy veterans, who have been deployed in support of OIF/OEF who do not have blast exposure or PTSD
Veterans with history of blast exposure
OIF/OEF veterans with a history of blast exposure who do not meet criteria for PTSD
Veterans with PTSD receiving usual care
OIF/OEF veterans with PTSD (with or without blast exposure) only who receive usual care (i.e., pharmacotherapy and/or supportive or psychodynamic individual or group therapy, not involving exposure therapy)
Veterans with PTSD receiving Virtual Reality Exposure Therapy
OIF/OEF veterans with PTSD (with or without blast exposure) that will receive Virtual Reality Exposure Therapy through the WRNMMC IRB approved protocol entitled "Enhancing Exposure Therapy for PTSD: Virtual Reality and Imaginal Exposure with Cognitive Enhancer" ClinicalTrials.gov Identifier: NCT01352637, which is also open to new enrollment
- Change from baseline functional MRI blood-oxygen-level-dependent (BOLD) signal at 3months [ Time Frame: baseline and 3months ]Functional MRI: Requires the exposure of subjects to various sensory stimuli while in the scanner, in order to assess the function of specific regions of the brain, by measuring the blood-oxygen-level-dependent (BOLD) signal. The Affective Stroop is a validated series of stimuli for distinguishing between those with PTSD and controls, that entails showing participants a variety of pictures (some neutral and some emotionally charged), and also asks them to distinguish between various number patterns.
- Clinician-Administered PTSD Scale (CAPS) [ Time Frame: baseline and 3months ]CAPS: Gold standard, 17-page instrument for the diagnosis of PTSD, which also provides a scaled measure of severity which can be followed for response to therapy.
- PTSD Checklist—Military Version (PCL-M) [ Time Frame: baseline and 3months ]PCL-M: This is a version of the 17-item PTSD Checklist that is oriented towards military veterans. Its psychometric properties have been well-established, and this version generally seems to perform better than the corresponding civilian version.
- Defense Veteran's Brain Injury Center (DVBIC)screen [ Time Frame: baseline and 3months ]Defense Veteran's Brain Injury Center (DVBIC) screen: A yes or no questionnaire regarding head injury with loss of consciousness and the presence of subsequent symptoms).
- CAGE and Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: baseline and 3month ]CAGE & AUDIT: assess for alcohol abuse and dependence.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990547
|United States, Maryland|
|National Intrepid Center of Excellence / Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20889|
|Principal Investigator:||Michael J Roy, MD, MPH, Colonel (Retired)||Uniformed Services University of the Health Sciences|