Status:
UNKNOWN
A Head-to-head Comparison of Virtual Reality Treatment for Post Traumatic Stress Disorder
Lead Sponsor:
United States Naval Medical Center, San Diego
Collaborating Sponsors:
Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury
The Geneva Foundation
Conditions:
Post Traumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 i...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00978484
Start Date
September 1 2009
End Date
October 1 2014
Last Update
June 30 2014
Active Locations (2)
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1
Camp Pendlton
Camp Pendlton, California, United States
2
Naval Medical Center San Diego (NMCSD)
San Diego, California, United States, 92134