- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00978484
A Head-to-head Comparison of Virtual Reality Treatment for Post Traumatic Stress Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
Camp Pendlton, California, United States
- Camp Pendlton
-
San Diego, California, United States, 92134
- Naval Medical Center San Diego (NMCSD)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Static Virtual Reality
Exposure Therapy using a still computer image
|
Exposure Therapy augmented with a still computer image
Other Names:
|
Experimental: Dynamic Virtual Reality
Virtual Reality Exposure Therapy using full, immersive Virtual Reality
|
10 weeks of Virtual Reality Exposure using full, immersive VR
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinician Administered PSTD Scale (CAPS)
Time Frame: Post Tx, and 3 month follow up
|
Post Tx, and 3 month follow up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PTSD Checklist, Military Version (PCL-M):
Time Frame: Post Tx, and 3 month follow up
|
Post Tx, and 3 month follow up
|
The Patient Health Questionnaire 9 (PHQ-9):
Time Frame: same
|
same
|
Beck Anxiety Inventory (BAI):
Time Frame: same
|
same
|
Behavioral Reactivity Test (BRT)
Time Frame: same
|
same
|
Automated Neuropsychological Assessment Metric (ANAM)
Time Frame: same
|
same
|
Mini International Neuropsychiatric Interview (MINI)
Time Frame: same
|
same
|
Shehan Disability Scale (SDS)
Time Frame: same
|
same
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Robert N McLay, MD/PhD, United States Naval Medical Center, San Diego
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- PTSD
- Depression
- Anxiety
- psychology
- Virtual Reality
- Military
- Prolonged Exposure
- Afghanistan
- Combat
- Exposure Therapy
- Army Personnel
- Air Force Personnel
- Navy Personnel
- Armed Forces Personnel
- Marines
- Soldiers
- Sailors
- combat disorders
- Iraq
- Computer Therapy
- Military Medicine
- Coast Guard
- military psychiatry
- combat neurosis
Additional Relevant MeSH Terms
Other Study ID Numbers
- W81XWH-08-1-0755
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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