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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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 thu
Sponsor: United States Naval Medical Center, San Diego

Current Primary Outcome: Clinician Administered PSTD Scale (CAPS) [ Time Frame: Post Tx, and 3 month follow up ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: United States Naval Medical Center, San Diego

Dates:
Date Received: September 16, 2009
Date Started: September 2009
Date Completion: October 2014
Last Updated: June 27, 2014
Last Verified: June 2014