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

Primary Purpose

Post Traumatic Stress Disorder

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Exposure Therapy - Dynamic
Augmented Exposure Therapy
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring 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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Camp Pendlton
  • Naval Medical Center San Diego (NMCSD)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Static Virtual Reality

Dynamic Virtual Reality

Arm Description

Exposure Therapy using a still computer image

Virtual Reality Exposure Therapy using full, immersive Virtual Reality

Outcomes

Primary Outcome Measures

Clinician Administered PSTD Scale (CAPS)

Secondary Outcome Measures

PTSD Checklist, Military Version (PCL-M):
The Patient Health Questionnaire 9 (PHQ-9):
Beck Anxiety Inventory (BAI):
Behavioral Reactivity Test (BRT)
Automated Neuropsychological Assessment Metric (ANAM)
Mini International Neuropsychiatric Interview (MINI)
Shehan Disability Scale (SDS)

Full Information

First Posted
September 16, 2009
Last Updated
June 27, 2014
Sponsor
United States Naval Medical Center, San Diego
Collaborators
Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, The Geneva Foundation, Marine Corps Base Camp Pendleton, Naval Hospital Camp Pendlton
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1. Study Identification

Unique Protocol Identification Number
NCT00978484
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Naval Medical Center, San Diego
Collaborators
Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, The Geneva Foundation, Marine Corps Base Camp Pendleton, Naval Hospital Camp Pendlton

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Static Virtual Reality
Arm Type
Active Comparator
Arm Description
Exposure Therapy using a still computer image
Arm Title
Dynamic Virtual Reality
Arm Type
Experimental
Arm Description
Virtual Reality Exposure Therapy using full, immersive Virtual Reality
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Exposure Therapy - Dynamic
Other Intervention Name(s)
VRE, VRET
Intervention Description
10 weeks of Virtual Reality Exposure using full, immersive VR
Intervention Type
Behavioral
Intervention Name(s)
Augmented Exposure Therapy
Other Intervention Name(s)
AET, Static VRE, Prolonged Exposure, PE
Intervention Description
Exposure Therapy augmented with a still computer image
Primary Outcome Measure Information:
Title
Clinician Administered PSTD Scale (CAPS)
Time Frame
Post Tx, and 3 month follow up
Secondary Outcome Measure Information:
Title
PTSD Checklist, Military Version (PCL-M):
Time Frame
Post Tx, and 3 month follow up
Title
The Patient Health Questionnaire 9 (PHQ-9):
Time Frame
same
Title
Beck Anxiety Inventory (BAI):
Time Frame
same
Title
Behavioral Reactivity Test (BRT)
Time Frame
same
Title
Automated Neuropsychological Assessment Metric (ANAM)
Time Frame
same
Title
Mini International Neuropsychiatric Interview (MINI)
Time Frame
same
Title
Shehan Disability Scale (SDS)
Time Frame
same

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert N McLay, MD/PhD
Organizational Affiliation
United States Naval Medical Center, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Camp Pendlton
City
Camp Pendlton
State/Province
California
Country
United States
Facility Name
Naval Medical Center San Diego (NMCSD)
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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