Enhancing Exposure Therapy for Post Traumatic Stress Disorder (PTSD): Virtual Reality and Imaginal Exposure With a Cognitive Enhancer
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the differences between four active treatment conditions
      for combat-related Post Traumatic Stress Disorder (PTSD): virtual reality exposure therapy
      (VRE) or prolonged imaginal exposure therapy (PE), both with DCS or placebo, as well as to
      examine predictors for PTSD and response to treatment in active duty military personnel,
      veterans, and civilians who served in Iraq and Afghanistan.
    

Detailed description: 
      Post Traumatic Stress Disorder (PTSD) is an anxiety disorder that can develop following
      exposure to traumatic events and includes symptoms of re-experiencing the trauma, such as
      through nightmares and flashbacks, avoidance and numbing, and physical hyperarousal. PTSD has
      been estimated to affect 10-20% of returning Operation Iraqi Freedom (OIF)/Operation Enduring
      Freedom (OEF) veterans. The most effective intervention found for PTSD is exposure therapy,
      which can be delivered in different formats, e. g. via virtual reality (VR) and as imaginal
      exposure. The goal of this study is to test the difference between 4 study conditions:
      virtual reality exposure therapy (VRE) or prolonged imaginal exposure therapy (PE), both
      combined with an antibiotic drug, DCS (active pill vs. placebo). D-Cycloserine (DCS), a drug
      that has been FDA approved for over 20 years, has been hypothesized to enhance the
      therapeutic effects of exposure therapy.). A secondary purpose of this study is to examine
      predictors for PTSD and response to PTSD intervention in active duty military personnel,
      veterans, and civilians who served in Iraq/Afghanistan. Psychophysiological factors (e.g.
      heart rate, blood pressure) and/or a genetic polymorphism (BDNF Val66Met) obtained from a
      saliva sample will be examined.

      The two primary co-aims are

        1. to examine the effects of DCS versus placebo (PLA) augmentation of exposure therapy on
           PTSD symptoms, and

        2. to examine the relative efficacy of virtual reality enhanced exposure therapy (VRE) and
           exposure therapy (PE) on PTSD symptoms.
    

Intervention name(s): DCS (D-Cycloserine ) + Prolonged Imaginal Exposure; DCS (D-Cycloserine ) + Virtual Reality Exposure; Placebo + Prolonged Imaginal Exposure; Placebo (sugar pill) + Virtual Reality Exposure
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 50mg DCS (taken once a week on the day of the therapy session) + Prolonged Imaginal Exposure; 50mg DCS (taken once a week on the day of the therapy session) + Virtual Reality Exposure; Placebo (taken once a week on the day of the therapy session) + Prolonged Imaginal Exposure; Placebo (taken once a week on the day of the therapy session) + Virtual Reality Exposure
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The two primary co-aims of this study are
to examine the effects of DCS versus placebo (PLA) augmentation of exposure therapy on PTSD symptoms and
to examine the relative efficacy of virtual reality enhanced exposure therapy (VRE) and exposure therapy (PE) on PTSD symptoms.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Traumatic Event; Trauma Survivor; Exposure Therapy; PTSD DCS; Virtual Reality Exposure; Veteran; Combat-related PTSD