This trial is active, not recruiting.

Condition post traumatic stress disorder
Treatments virtual reality exposure therapy - dynamic, augmented exposure therapy
Phase phase 3
Sponsor United States Naval Medical Center, San Diego
Collaborator Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury
Start date September 2009
End date September 2014
Trial size 150 participants
Trial identifier NCT00978484, W81XWH-08-1-0755


Therapy that uses Virtual Reality (VR) has been shown to help in the treatment of Post Traumatic Stress Disorder (PTSD). It is unclear what role the VR simulator itself plays in recovery. This study is examining if full-immersion in VR causes greater improvement in PTSD symptoms than does similar therapy that uses a simple, static, computer image.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(Active Comparator)
Exposure Therapy using a still computer image
augmented exposure therapy AET
Exposure Therapy augmented with a still computer image
Virtual Reality Exposure Therapy using full, immersive Virtual Reality
virtual reality exposure therapy - dynamic VRE
10 weeks of Virtual Reality Exposure using full, immersive VR

Primary Outcomes

Clinician Administered PSTD Scale (CAPS)
time frame: Post Tx, and 3 month follow up

Secondary Outcomes

PTSD Checklist, Military Version (PCL-M):
time frame: Post Tx, and 3 month follow up
The Patient Health Questionnaire 9 (PHQ-9):
time frame: same
Beck Anxiety Inventory (BAI):
time frame: same
Behavioral Reactivity Test (BRT)
time frame: same
Automated Neuropsychological Assessment Metric (ANAM)
time frame: same
Mini International Neuropsychiatric Interview (MINI)
time frame: same
Shehan Disability Scale (SDS)
time frame: same

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title A Head-to-head Comparison of Virtual Reality Treatment for Post Traumatic Stress Disorder
Principal investigator Robert N McLay, MD/PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by United States Naval Medical Center, San Diego.