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

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00978484
• Other study ID #: W81XWH-08-1-0755
• Secondary ID: W81XWH-08-1-0755
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 16, 2009
• Last updated: June 27, 2014
• Start date: September 2009
• Est. completion date: October 2014

Study information

• Verified date: June 2014
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal GovernmentUnited States: Human Research Protection Office Office of Research Protections U.S. Army Medical Research and Materiel CommandUnited States: Department of the Navy Human Research Protection Program
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Virtual Reality Exposure Therapy - Dynamic
10 weeks of Virtual Reality Exposure using full, immersive VR
• Augmented Exposure Therapy
Exposure Therapy augmented with a still computer image

Locations

Country	Name	City	State
United States	Camp Pendlton	Camp Pendlton	California
United States	Naval Medical Center San Diego (NMCSD)	San Diego	California

Sponsors (5)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego	Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, Marine Corps Base Camp Pendlton, Naval Hospital Camp Pendlton, The Geneva Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PSTD Scale (CAPS)		Post Tx, and 3 month follow up	No
Secondary	PTSD Checklist, Military Version (PCL-M):		Post Tx, and 3 month follow up	No
Secondary	The Patient Health Questionnaire 9 (PHQ-9):		same	Yes
Secondary	Beck Anxiety Inventory (BAI):		same	No
Secondary	Behavioral Reactivity Test (BRT)		same	No
Secondary	Automated Neuropsychological Assessment Metric (ANAM)		same	No
Secondary	Mini International Neuropsychiatric Interview (MINI)		same	Yes
Secondary	Shehan Disability Scale (SDS)		same	No