Back to resultsVirtual Reality (VR) Therapy for Post-Traumatic Stress Disorder (PTSD)
Primary Purpose
Post-Traumatic Stress Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Treatment as Usual
Virtual Reality Exposure with Stimulus Control
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Virtual Reality, Post Traumatic Stress Disorder, Combat, Military, Major Depressive Disorder, Anxiety, Virtual Reality Exposure with Stimulus Control, Treatment as Usual
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with Post Traumatic Stress Disorder related to military service in Iraq or Afghanistan by a Military Medical Provider.
Willing and able to give informed consent to participate Willing to give up intoxicating substances on the days of therapy
Exclusion Criteria:
- Actively suicidal, homicidal, psychotic, or having a diagnosis of alcohol dependence that does not show signs of at least early remission
Sites / Locations
- Naval Hosptial Camp Pendleton
- Naval Medical Center San Diego (NMCSD)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Virtual Reality Therapy
Treatment As Usual
Arm Description
10 Weeks of Virtual Reality Exposure with Stimulus Control, with up to twice a week, 90 min sessions
Traditional Therapy and Psychiatric Medication
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00992953
First Posted
October 8, 2009
Last Updated
October 8, 2009
Sponsor
Office of Naval Research (ONR)
Collaborators
Naval Hospital Camp Pendleton, Virtual Reality Medical Center, United States Naval Medical Center, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT00992953
Brief Title
Virtual Reality (VR) Therapy for Post-Traumatic Stress Disorder (PTSD)
Official Title
The Efficacy of Virtual Reality (VR) as an Adjunct Therapy for Acute Combat-related Post-Traumatic Stress Disorder (PTSD) in Non-Combatants
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Office of Naval Research (ONR)
Collaborators
Naval Hospital Camp Pendleton, Virtual Reality Medical Center, United States Naval Medical Center, San Diego
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
It is proposed that using Virtual Reality as part of therapy will result in improvements in Post Traumatic Stress Disorder for Service Members with PTSD related to service in Iraq and/or Afghanistan.
Detailed Description
In the treatment development phase, participants will be enrolled in Virtual Reality therapy. The therapy will be based on principals of exposure therapy, but will also incorporate aspects of physiological monitoring, and cognitive restructuring. The therapy will be modified as indicated by clinical feedback, with a fixed protocol to be developed (with length of treatment and exact methods to be used to be determined). After a fixed protocol is agreed upon, the project will enter the randomized phase. In this portion, subjects will be randomly assigned to receive either the Virtual Reality Treatment, or sent back to a waiting list during which time they will receive usual treatment. Participants will be assessed to determine which treatment (VR or treatment as usual) results in the greatest improvements in PTSD, as measured by independent assessors using the Clinician Administered PTSD scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
Virtual Reality, Post Traumatic Stress Disorder, Combat, Military, Major Depressive Disorder, Anxiety, Virtual Reality Exposure with Stimulus Control, Treatment as Usual
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Therapy
Arm Type
Experimental
Arm Description
10 Weeks of Virtual Reality Exposure with Stimulus Control, with up to twice a week, 90 min sessions
Arm Title
Treatment As Usual
Arm Type
Active Comparator
Arm Description
Traditional Therapy and Psychiatric Medication
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Other Intervention Name(s)
TAU
Intervention Description
10 weeks of therapy and/or psychiatric medication as available
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Exposure with Stimulus Control
Other Intervention Name(s)
Virtual Reality Gradual Exposure Treatment, VRGET, Virtual Reality Exposure, VRE
Intervention Description
10 weeks of therapy, up to twice a week, 90 min sessions involving Virtual Reality Exposure with Stimulus Control
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:
Diagnosed with Post Traumatic Stress Disorder related to military service in Iraq or Afghanistan by a Military Medical Provider.
Willing and able to give informed consent to participate Willing to give up intoxicating substances on the days of therapy
Exclusion Criteria:
Actively suicidal, homicidal, psychotic, or having a diagnosis of alcohol dependence that does not show signs of at least early remission
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda Wiederhold, PhD
Organizational Affiliation
Virtual Reality Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Hosptial Camp Pendleton
City
Camp Pendlton
State/Province
California
ZIP/Postal Code
92134
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
Virtual Reality (VR) Therapy for Post-Traumatic Stress Disorder (PTSD)
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