BraveMind: Advancing the Virtual Iraq/Afghanistan PTSD Exposure Therapy
Completed · Phase 2
Conditions studied: Trauma, Post-Traumatic Stress Disorder
In brief
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.
Key facts
- Study ID
- NCT02246972
- Run by
- Emory University
- People needed
- 15
- Starts
- 2015-05-01
- Expected to finish
- 2017-07-01
- Last updated by the study team
- 2017-08-09
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants will be 45 males and females between ages of 18 and 65
- Participants must meet DSM-V criteria for PTSD due to military sexual trauma (MST)
- Patients must be literate in English
- Patients must be medically stable
- Participants must comprehend his or her role in the study and the risks involved
You may not qualify if…
- Patients with a history of mania, schizophrenia, or other psychoses
- Patients with active suicidal risk
- Patients with current alcohol or drug dependence
- Patients unable to wear the VR head mounted display
- Patients on psychotropic medications must have been on a stable dose for at least 2 months prior to beginning the study and must agree not to change their current medication regimen throughout the course of the study
Where it is running
- Emory University — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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