Clinical trial NCT00978484: A Head-to-head Comparison of Virtual Reality Treatment for Post Traumatic Stress Disorder
Official title: A Head-to-head Comparison of Virtual Reality Treatment for Post Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Post Traumatic Stress Disorder
Keywords: PTSD
Depression
Anxiety
Virtual Reality
Computer Therapy
Exposure Therapy
Prolonged Exposure
Military Medicine
Combat
Iraq
Afghanistan
Air Force Personnel
Armed Forces Personnel
Army Personnel
Coast Guard
psychology
military psychiatry
combat disorders
combat neurosis
Marines
Military
Navy Personnel
Sailors
Soldiers
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury
name: The Geneva Foundation
name: Marine Corps Base Camp Pendleton
name: Naval Hospital Camp Pendleton
First posted: 2009-09-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinician Administered PSTD Scale (CAPS)
timeFrame: Post Tx, and 3 month follow up
Secondary outcomes:
measure: PTSD Checklist, Military Version (PCL-M):
timeFrame: Post Tx, and 3 month follow up
measure: The Patient Health Questionnaire 9 (PHQ-9):
timeFrame: same
measure: Beck Anxiety Inventory (BAI):
timeFrame: same
measure: Behavioral Reactivity Test (BRT)
timeFrame: same
measure: Automated Neuropsychological Assessment Metric (ANAM)
timeFrame: same
measure: Mini International Neuropsychiatric Interview (MINI)
timeFrame: same
measure: Shehan Disability Scale (SDS)
timeFrame: same
Other outcomes:
Locations:
city: Camp Pendlton
country: United States
facility: Camp Pendlton
state: California
city: San Diego
country: United States
facility: Naval Medical Center San Diego (NMCSD)
state: California
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: Robert N McLay, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: