Virtual Reality Therapy and Imaging in Combat Veterans With Blast Injury and Posttraumatic Stress Disorder (ViRTICo-BP)
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|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|
|Actual Primary Completion Date :||July 2014|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|