A Head-to-head Comparison of Virtual Reality Treatment for Post Traumatic Stress Disorder

Exposure Therapy (ET) is the current gold standard for treating Post Traumatic Stress
Disorder (PTSD). Although ET has the best evidence in its favor, it is also clear that the
treatment is less than perfect in achieving remission of PTSD. Attempts have been made to
improve on traditional ET by augmenting the exposure using Virtual Reality (VR). Open
label trials of VR assisted ET (VRET) showed this method to be safe and effective, and
suggested remission rates that were higher than normally seen with ET alone. For the
treatment of phobias, head to head comparison with traditional ET has shown VRET to be
superior. For PTSD, trials that directly pit VRET against traditional ET, and against other
traditional therapy, are ongoing, but it is already clear that some individuals who fail to
respond to traditional ET do get better once VR is added. Lost in the rush to develop
VRET, however, has been any direct testing of its signature aspect, the VR itself. There
are theoretical reasons to believe that VR might enhance ET in special ways. However there
are other reasons to believe that any form of Augmented Exposure Therapy (AET) that
introduced sights and sounds from the trauma would do just as well. VR, although exciting,
is expensive, cumbersome, and not available at most treatment facilities. If similar
effects could be achieved using more primitive technology, it would open up the possibility
of enhanced ET to a much wider range of patients. Conversely, if VRET were shown to be
superior to simplified AET, it would argue for a unique role of VR in psychotherapy. Not
only would this be theoretically important for neuroscientists, it would indicate VRET as a
"platinum" standard for treating PTSD. For the past four years, programs at Naval Medical
Center San Diego (NMCSD) and Naval Hospital Camp Pendleton have collaborated with VR
companies and researcher to build and test VR systems to treat PTSD in Service Members
returning from Iraq and Afghanistan. NMCSD thus has the experience to perform the
necessary experiments. The existing equipment also means that NMCSD has the unique ability
to carry out such a test without any additional input from the companies that make VR
systems. We propose to perform a randomized, head-to-head study that compares VRET to AET.
We propose to perform a randomized, head-to-head study that compares VRET to AET. Up to 300
patients would be recruited with the goal of treating 40 patients with VR and 40 patients
with the control (AET) therapy. The same techniques, measures, and controls would be used
that NMCSD has already put in place to develop VRET for PTSD. Also, a cost-benefit
analysis would be used to determine the benefits of VRET.

Inclusion Criteria:

Subjects must be eligible to receive care at NMCSD or Camp Pendleton, willing and able to
give informed consent, aged 18 to 60, have a PTSD diagnosis from combat operations in Iraq
or Afghanistan based on DSM-IV criteria and Clinician Administered PTSD Scale (CAPS) score
greater than 40, have an index trauma that occurred in Iraq or Afghanistan, be medically
able to tolerate exposure treatment and physically able to don virtual reality headset and
physiological monitoring equipment as assed by their medical provider, be willing and able
to give up alcohol and/or other intoxicating substances within 12 hours of a VR treatment
session, and be able to see, hear, and smell

Exclusion Criteria:

Subjects would be excluded or dropped from the study if they exhibit psychosis, mania,
epilepsy, have current suicidal intent, are less than 30 days from a psychiatric
hospitalization or suicide attempt, meet criteria for current, active substance
dependence, use an intoxicating substance within 12 hours of a treatment session, or have
another condition or event that the treating provider or medical monitor consider to be a
safety hazard within the study. Subjects may also drop out of the study at any point with
the assurance that they will be referred to other care as needed.