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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
Sponsor:
Collaborators:
Uniformed Services University of the Health Sciences
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Walter Reed National Military Medical Center

Tracking Information
First Submitted Date November 6, 2013
First Posted Date November 21, 2013
Last Update Posted Date February 10, 2016
Study Start Date Not Provided
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2013)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01990547 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 20, 2013)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Virtual Reality Therapy and Imaging in Combat Veterans With Blast Injury and Posttraumatic Stress Disorder
Official Title The ViRTICo-BP Trials: Virtual Reality Therapy and Imaging in Combat Veterans With Blast Injury and Posttraumatic Stress Disorder
Brief Summary The main purpose of this study is to determine whether functional magnetic resonance imaging (fMRI), can distinguish between service members with and without traumatic brain injury (TBI), as well as those with posttraumatic stress disorder (PTSD) who receive either virtual reality exposure therapy (VRET) or PTSD treatment other than exposure therapy. The investigators and other investigators have previously identified changes in function in multiple regions of the brain in combat veterans with PTSD, and the investigators have also seen that structural changes in the white matter associated with combat TBI are also linked with changes in function, and in turn with PTSD symptoms. However, the investigators need to confirm these findings in larger numbers, and also need to discern whether fMRI can distinguish if there is something significantly different about those who have PTSD after TBI vs. those in whom it does not follow a TBI. Finally, the investigators have previously demonstrated that exposure therapy ameliorates the functional changes in the brain induced by PTSD, but the investigators do not know if similar changes occur with other forms of therapy, so the investigators seek to compare the two directly. It is our expectation that the findings will better inform the choice of therapy for service members with combat-related PTSD, with or without TBI.
Detailed Description The investigators have previously demonstrated that military service members (SMs) with PTSD related to deployment to Iraq or Afghanistan have fMRI brain activation patterns similar to those reported in other populations with PTSD. The investigators have also demonstrated significant improvements, or normalization, in the activation of each of these brain areas following exposure therapy. In this study the investigators will assess recovery in SMs receiving virtual reality exposure therapy, comparing them to healthy veterans, those with history of blast exposure and those with PTSD receiving usual care. The investigators hope to (1) demonstrate that fMRI can distinguish between military service members with PTSD, with mild TBI, and those who have neither; (2) demonstrate that significant differences are not seen in brain activation patterns merely by repeating fMRI scans at 3 month intervals but when significant changes are present they in fact represent the effect of the exposure therapy intervention; (3) discern whether those with PTSD after TBI have different activation patterns than those with PTSD in the absence of TBI; and (4) identify fMRI characteristics of resilience in service members who have been deployed but did not develop PTSD.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Combat OIF/OEF Veterans
Condition
  • Post-Traumatic Stress Disorder
  • Blast Injury
Intervention Not Provided
Study Groups/Cohorts
  • Healthy Veterans
    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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: November 20, 2013)
88
Original Estimated Enrollment Same as current
Actual Study Completion Date August 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria

  1. Over 18 years of age.
  2. Able to give written informed consent prior to participation in this study.
  3. Good overall health. Subjects with stable medical problems (e.g., hypertension, hypothyroidism, diabetes mellitus) that are fully under control with treatment will be included.
  4. Specific criteria according to arm:

    1. Healthy OIF/OEF veterans who deployed for at least 3 months in support of OIF/OEF who do not have blast exposure (i.e., within 100 feet of a blast, in which the pressure wave knocked them to the ground or caused other physical symptoms, or the vehicle in which they were riding hit an improvised explosive device, jarring them from their seat) or PTSD: PCL-M<50, negative history of concussion or loss of consciousness.
    2. OIF/OEF veterans with a history of blast exposure (as defined above) who do not meet criteria for PTSD (PCL-M <50)
    3. OIF/OEF veterans with PTSD only who receive usual care: any form of individual or group psychotherapy so long as it does not include exposure therapy, and/or may be on any combination of prescription psychotropic medications; participants in this group may or may not have a history of blast exposure, provided they did not have loss of consciousness of 60 minutes or more or otherwise meet any criteria for moderate or severe TBI.
    4. OIF/OEF veterans with PTSD that will receive VRET through the WRNMMC IRB approved protocol entitled "Enhancing Exposure Therapy for PTSD: Virtual Reality and Imaginal Exposure with Cognitive Enhancer": must meet entry criteria for that study; most notably, they must have combat-related PTSD; participants in this group may or may not have a history of blast exposure, provided they did not have loss of consciousness of 60 minutes or more or otherwise meet any criteria for moderate or severe TBI.

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Exclusion Criteria

  1. Dementia or an inability to read or understand written and oral questions for any other reason.
  2. The presence of a clinically significant or unstable medical disorder (e.g., unstable angina, uncontrolled diabetes mellitus, uncontrolled hypertension, symptomatic liver or kidney disease).
  3. Meet DSM-IV criteria for alcohol abuse within 1 month prior to screening.
  4. Meet DSM-IV criteria for alcohol and/or substance dependence within 1 month prior to screening.
  5. Currently at imminent or high risk for homicide or suicide.
  6. A current or past history of schizophrenia, schizoaffective disorder, and bipolar disorder. However, those with a comorbid history of other Axis 1 disorders such as major depression, dysthymia, or panic disorder will be included, if there are neither psychotic features nor significant suicidal or homicidal ideation.
  7. Active pregnancy, actively seeking to become pregnant or being unwilling to use birth control measures if of child-bearing age and sexually active.
  8. Residual shrapnel fragments retained within the body as a result of blast injury, or any prosthetic ferro-magnetic metal devices within the body that would pose health risks with the use of MRI. Those with MRI-safe surgical devices such as titanium will be permitted.
  9. History of claustrophobia or inability to tolerate an MRI in the past without use of sedating medicine, as the use of sedating medicine could interfere with interpretation of the fMRI.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01990547
Other Study ID Numbers 20318-17
N0001407MP20086 ( Other Grant/Funding Number: Office of Naval Research )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Walter Reed National Military Medical Center
Study Sponsor Walter Reed National Military Medical Center
Collaborators
  • Uniformed Services University of the Health Sciences
  • National Institutes of Health (NIH)
Investigators
Principal Investigator: Michael J Roy, MD, MPH, Colonel (Retired) Uniformed Services University of the Health Sciences
PRS Account Walter Reed National Military Medical Center
Verification Date February 2016