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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury
The Geneva Foundation
Marine Corps Base Camp Pendlton
Naval Hospital Camp Pendlton
Information provided by (Responsible Party):
Robert McLay, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT00978484
First received: September 16, 2009
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Post Traumatic Stress Disorder
Behavioral: Virtual Reality Exposure Therapy - Dynamic
Behavioral: Augmented Exposure Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Head-to-head Comparison of Virtual Reality Treatment for Post Traumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, San Diego:

Primary Outcome Measures:
  • Clinician Administered PSTD Scale (CAPS) [ Time Frame: Post Tx, and 3 month follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PTSD Checklist, Military Version (PCL-M): [ Time Frame: Post Tx, and 3 month follow up ] [ Designated as safety issue: No ]
  • The Patient Health Questionnaire 9 (PHQ-9): [ Time Frame: same ] [ Designated as safety issue: Yes ]
  • Beck Anxiety Inventory (BAI): [ Time Frame: same ] [ Designated as safety issue: No ]
  • Behavioral Reactivity Test (BRT) [ Time Frame: same ] [ Designated as safety issue: No ]
  • Automated Neuropsychological Assessment Metric (ANAM) [ Time Frame: same ] [ Designated as safety issue: No ]
  • Mini International Neuropsychiatric Interview (MINI) [ Time Frame: same ] [ Designated as safety issue: Yes ]
  • Shehan Disability Scale (SDS) [ Time Frame: same ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: September 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Static Virtual Reality
Exposure Therapy using a still computer image
Behavioral: Augmented Exposure Therapy
Exposure Therapy augmented with a still computer image
Other Names:
  • AET
  • Static VRE
  • Prolonged Exposure
  • PE
Experimental: Dynamic Virtual Reality
Virtual Reality Exposure Therapy using full, immersive Virtual Reality
Behavioral: Virtual Reality Exposure Therapy - Dynamic
10 weeks of Virtual Reality Exposure using full, immersive VR
Other Names:
  • VRE
  • VRET

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978484

Locations
United States, California
Camp Pendlton
Camp Pendlton, California, United States
Naval Medical Center San Diego (NMCSD)
San Diego, California, United States, 92134
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury
The Geneva Foundation
Marine Corps Base Camp Pendlton
Naval Hospital Camp Pendlton
Investigators
Principal Investigator: Robert N McLay, MD/PhD United States Naval Medical Center, San Diego
  More Information

No publications provided

Responsible Party: Robert McLay, PI, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT00978484     History of Changes
Other Study ID Numbers: W81XWH-08-1-0755, W81XWH-08-1-0755
Study First Received: September 16, 2009
Last Updated: June 27, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government
United States: Human Research Protection Office Office of Research Protections U.S. Army Medical Research and Materiel Command
United States: Department of the Navy Human Research Protection Program

Keywords provided by United States Naval Medical Center, San Diego:
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

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014