BraveMind: Advancing the Virtual Iraq/Afghanistan PTSD Exposure Therapy
Condition: Trauma; Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed study is designed to test the clinical efficacy of the BRAVEMIND military sexual
      trauma (MST) system in an initial feasibility and wait list clinical trial of 45 users.

      The following hypotheses will be tested:

        1. Virtual Reality Exposure Therapy (VRET) will be safely deliverable to persons with
           posttraumatic stress disorder (PTSD) due to MST as evidenced by treatment dropout rates
           that are similar to existing Prolonged Exposure (PE) therapy delivered in military
           samples (20-40%) and by the absence of any critical incidents.

        2. Participants in the VRET group will show statistically and clinically meaningful
           reductions in PTSD and depression (PTSD Checklist-Military (PCL-M), Clinician
           Administered PTSD Scale (CAPS), and Patient Health Questionnaire (PHQ-9) scores and
           psychophysiological measures) following treatment.

        3. Participants in the VRET group will show statistically and clinically meaningful
           reductions in PTSD and depression (PCL-M, CAPS, PHQ-9 scores and psychophysiological
           measures) compared to wait-list results.
    

Detailed description: 
      Pre-Treatment Assessment:

      Potential subjects will be asked to provide a copy of their DD214 to verify their military
      service record. Once a potential participant has met all screening inclusion and exclusion
      criteria and consented to participate, the CAPS will be administered to determine current
      PTSD status.

      Randomization:

      Following pre-treatment assessment, patients will be randomized to receive VRET (Virtual
      Reality Exposure Therapy) immediately or wait 6 weeks during which time they will continue to
      receive usual care. Wait-listed participants will be reassessed prior to beginning their
      course of treatment with the Clinician Administered PTSD Scale (CAPS), PTSD
      Checklist-Military (PCL-M), Beck Depression Inventory-II (BDI-II), and psychophysiological
      measures. This pre-treatment assessment visit will last about 2-3 hours.

      Therapy:

      Participants will be treated once or twice per week for 6-12 sessions. VRET treatment will be
      limited to a minimum of 6 sessions and a maximum of 12 sessions, based upon reaching
      criterion of 70% symptom improvement as indicated on the PCL-M from baseline or an agreement
      between clinician and participant that maximum treatment response has been achieved. All
      sessions will be individual and weekly or twice weekly. The first session will last
      approximately 90 minutes and will be spent in information gathering, treatment planning, and
      explaining the treatment rationale to the patient. Information gathering will review the
      history of PTSD and their military service and will include a brief psychosocial history,
      including review of prior treatment.

      Session 2 will discuss in vivo exposure and construct the hierarchy for in vivo exposure. The
      VRET sessions will last 90 minutes each. During VRET sessions patients will wear a
      head-mounted display with stereo earphones that will provide visual and audio cues consistent
      with Iraqi or Afghan military scenarios or other base-related scenarios as appropriate for
      the individual patient. The therapist will make appropriate comments and encourage continued
      exposure to the identified index trauma until anxiety has habituated. During exposure,
      information will be gathered on the participant's anxiety level through the use of a 0-100
      Subjective Units of Discomfort (SUDs) scale. All therapists will have been trained in
      Prolonged Imaginal Exposure therapy (PE) followed by training in VRET by Drs. Rothbaum and
      Gerardi. Drs. Rothbaum and Gerardi will supervise all therapy.
    

Intervention name(s): Virtual Reality Exposure Therapy (VRET)
Intervention type(s): Behavioral
Intervention description(s): 6 to 12 90-minute individual treatment sessions. During VRET sessions patients will wear a head-mounted display with stereo earphones that will provide visual and audio cues consistent with Iraqi or Afghan military scenarios or other base-related scenarios as appropriate for the individual patient.
Other intervention name(s): VRET
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Military sexual trauma; Veterans; Women in the military; Sexual assault