Trauma Clinical Trial
Official title:
BRAVEMIND: Advancing the Virtual Iraq/Afghanistan PTSD Exposure Therapy System for MST
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.
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.
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