Virtual Reality (VR) Therapy for Post-Traumatic Stress Disorder (PTSD)

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy of Virtual Reality (VR) as an Adjunct Therapy for Acute Combat-related Post-Traumatic Stress Disorder (PTSD) in Non-Combatants

Conditions
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Post-Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Treatment as Usual
* Behavioral: Virtual Reality Exposure with Stimulus Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Therapy<br>10 Weeks of Virtual Reality Exposure with Stimulus Control, with up to twice a week, 90 min sessions | Behavioral: Virtual Reality Exposure with Stimulus Control<br>* 10 weeks of therapy, up to twice a week, 90 min sessions involving Virtual Reality Exposure with Stimulus Control<br>* Other names: VRE;|
| Active Comparator: Treatment As Usual<br>Traditional Therapy and Psychiatric Medication | Behavioral: Treatment as Usual<br>* 10 weeks of therapy and/or psychiatric medication as available<br>* Other names: TAU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Post Traumatic Stress Disorder, Combat, Military, Major Depressive Disorder, Anxiety, Virtual Reality Exposure with Stimulus Control, Treatment as Usual