Virtual Reality Therapy and Imaging in Combat Veterans With Blast Injury and Posttraumatic Stress Disorder
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| End Date: | August 2014 |
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.
(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.
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.
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.
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.
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.
We found this trial at
1
site
Bethesda, Maryland 20889
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