Post-Traumatic Stress DisorderViRTICo-BPNCT01990547
Virtual Reality Therapy and Imaging in Combat Veterans With Blast Injury and Posttraumatic Stress Disorder
An observational study of Post-Traumatic Stress Disorder and Blast Injury, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder, Blast Injury
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Combat OIF/OEF Veterans
Who may be able to join
- Over 18 years of age.
- Able to give written informed consent prior to participation in this study.
- Good overall health. Subjects with stable medical problems (e.g., hypertension, hypothyroidism, diabetes mellitus) that are fully under control with treatment will be included.
- Specific criteria according to arm:
- 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.
- OIF/OEF veterans with a history of blast exposure (as defined above) who do not meet criteria for PTSD (PCL-M <50)
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- 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.
- 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.
- --
Who cannot join
- Dementia or an inability to read or understand written and oral questions for any other reason.
- The presence of a clinically significant or unstable medical disorder (e.g., unstable angina, uncontrolled diabetes mellitus, uncontrolled hypertension, symptomatic liver or kidney disease).
- Meet DSM-IV criteria for alcohol abuse within 1 month prior to screening.
- Meet DSM-IV criteria for alcohol and/or substance dependence within 1 month prior to screening.
- Currently at imminent or high risk for homicide or suicide.
- 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.
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- Active pregnancy, actively seeking to become pregnant or being unwilling to use birth control measures if of child-bearing age and sexually active.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Intrepid Center of Excellence / Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: The ViRTICo-BP Trials: Virtual Reality Therapy and Imaging in Combat Veterans With Blast Injury and Posttraumatic Stress Disorder
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.
Read the 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.
- Conditions
- Post-Traumatic Stress Disorder, Blast Injury
- Keywords
- Virtual Reality Exposure Therapy, functional Magnetic Resonance Imaging, Traumatic Event, Trauma Survivor, Combat-related PTSD, mTBI, mild TBI, PTSD, Veteran
- Medical subject headings
- Stress Disorders, Post-Traumatic, Blast Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline functional MRI blood-oxygen-level-dependent (BOLD) signal at 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.
Measured: baseline and 3months
Secondary outcomes (4)
Clinician-Administered PTSD Scale (CAPS)
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.
Measured: baseline and 3months
PTSD Checklist-Military Version (PCL-M)
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.
Measured: baseline and 3months
Defense Veteran's Brain Injury Center (DVBIC)screen
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).
Measured: baseline and 3months
CAGE and Alcohol Use Disorders Identification Test (AUDIT)
CAGE \& AUDIT: assess for alcohol abuse and dependence.
Measured: baseline and 3month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Uniformed Services University of the Health Sciences, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Michael J Roy, MD, MPH, Colonel (Retired), Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990547
- Sponsor's protocol ID
- 20318-17
- Other IDs
- N0001407MP20086
- Acronym
- ViRTICo-BP
- Status last verified
- Feb 2016
- First submitted
- 6 Nov 2013
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roy MJ, Francis J, Friedlander J, Banks-Williams L, Lande RG, Taylor P, Blair J, McLellan J, Law W, Tarpley V, Patt I, Yu H, Mallinger A, Difede J, Rizzo A, Rothbaum B. Improvement in cerebral function with treatment of posttraumatic stress disorder. Ann N Y Acad Sci. 2010 Oct;1208:142-9. doi: 10.1111/j.1749-6632.2010.05689.x.
PubMed 20955336Roy MJ, Costanzo ME, Blair JR, Rizzo AA. Compelling Evidence that Exposure Therapy for PTSD Normalizes Brain Function. Stud Health Technol Inform. 2014;199:61-5.
PubMed 24875691
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ViRTICo-BP Trials: Virtual Reality Therapy and Imaging in Combat Veterans With Blast Injury and Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01990547
- Acronym / sponsor ID
- ViRTICo-BP / 20318-17
- Conditions
- Post-Traumatic Stress Disorder, Blast Injury
- Keywords
- Virtual Reality Exposure Therapy, functional Magnetic Resonance Imaging, Traumatic Event, Trauma Survivor, Combat-related PTSD, mTBI, mild TBI, PTSD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Collaborators
- Uniformed Services University of the Health Sciences, National Institutes of Health (NIH)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Combat OIF/OEF Veterans
Key inclusion criteria (9 listed)
- Over 18 years of age.
- Able to give written informed consent prior to participation in this study.
- Good overall health. Subjects with stable medical problems (e.g., hypertension, hypothyroidism, diabetes mellitus) that are fully under control with treatment will be included.
- Specific criteria according to arm:
- --
Key exclusion criteria (9 listed)
- Dementia or an inability to read or understand written and oral questions for any other reason.
- The presence of a clinically significant or unstable medical disorder (e.g., unstable angina, uncontrolled diabetes mellitus, uncontrolled hypertension, symptomatic liver or kidney disease).
- Meet DSM-IV criteria for alcohol abuse within 1 month prior to screening.
- Meet DSM-IV criteria for alcohol and/or substance dependence within 1 month prior to screening.
- Currently at imminent or high risk for homicide or suicide.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Clinician-Administered PTSD Scale (CAPS)
Time frame: baseline and 3months
PTSD Checklist-Military Version (PCL-M)
Time frame: baseline and 3months
Defense Veteran's Brain Injury Center (DVBIC)screen
Time frame: baseline and 3months
CAGE and Alcohol Use Disorders Identification Test (AUDIT)
Time frame: baseline and 3month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
- Results publication: PubMed 20955336Roy MJ, Francis J, Friedlander J, Banks-Williams L, Lande RG, Taylor P, Blair J, McLellan J, Law W, Tarpley V, Patt I, Yu H, Mallinger A, Difede J, Rizzo A, Rothbaum B. Improvement in cerebral function with treatment of posttraumatic stress disorder. Ann N Y Acad Sci. 2010 Oct;1208:142-9. doi: 10.1111/j.1749-6632.2010.05689.x.
- Results publication: PubMed 24875691Roy MJ, Costanzo ME, Blair JR, Rizzo AA. Compelling Evidence that Exposure Therapy for PTSD Normalizes Brain Function. Stud Health Technol Inform. 2014;199:61-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Roy, MD, MPH, Colonel (Retired) principal investigator
Uniformed Services University of the Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Traumatic Stress Disorder and Blast Injury, run by Walter Reed National Military Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline functional MRI blood-oxygen-level-dependent (BOLD) signal at 3months (time frame: baseline and 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01990547, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2016.