<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02246972</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00072196</org_study_id>
    <nct_id>NCT02246972</nct_id>
  </id_info>
  <brief_title>BraveMind: Advancing the Virtual Iraq/Afghanistan PTSD Exposure Therapy</brief_title>
  <official_title>BRAVEMIND: Advancing the Virtual Iraq/Afghanistan PTSD Exposure Therapy System for MST</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Telemedicine &amp; Advanced Technology Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study is designed to test the clinical efficacy of the BRAVEMIND military sexual&#xD;
      trauma (MST) system in an initial feasibility and wait list clinical trial of 45 users.&#xD;
&#xD;
      The following hypotheses will be tested:&#xD;
&#xD;
        1. Virtual Reality Exposure Therapy (VRET) will be safely deliverable to persons with&#xD;
           posttraumatic stress disorder (PTSD) due to MST as evidenced by treatment dropout rates&#xD;
           that are similar to existing Prolonged Exposure (PE) therapy delivered in military&#xD;
           samples (20-40%) and by the absence of any critical incidents.&#xD;
&#xD;
        2. Participants in the VRET group will show statistically and clinically meaningful&#xD;
           reductions in PTSD and depression (PTSD Checklist-Military (PCL-M), Clinician&#xD;
           Administered PTSD Scale (CAPS), and Patient Health Questionnaire (PHQ-9) scores and&#xD;
           psychophysiological measures) following treatment.&#xD;
&#xD;
        3. Participants in the VRET group will show statistically and clinically meaningful&#xD;
           reductions in PTSD and depression (PCL-M, CAPS, PHQ-9 scores and psychophysiological&#xD;
           measures) compared to wait-list results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pre-Treatment Assessment:&#xD;
&#xD;
      Potential subjects will be asked to provide a copy of their DD214 to verify their military&#xD;
      service record. Once a potential participant has met all screening inclusion and exclusion&#xD;
      criteria and consented to participate, the CAPS will be administered to determine current&#xD;
      PTSD status.&#xD;
&#xD;
      Randomization:&#xD;
&#xD;
      Following pre-treatment assessment, patients will be randomized to receive VRET (Virtual&#xD;
      Reality Exposure Therapy) immediately or wait 6 weeks during which time they will continue to&#xD;
      receive usual care. Wait-listed participants will be reassessed prior to beginning their&#xD;
      course of treatment with the Clinician Administered PTSD Scale (CAPS), PTSD&#xD;
      Checklist-Military (PCL-M), Beck Depression Inventory-II (BDI-II), and psychophysiological&#xD;
      measures. This pre-treatment assessment visit will last about 2-3 hours.&#xD;
&#xD;
      Therapy:&#xD;
&#xD;
      Participants will be treated once or twice per week for 6-12 sessions. VRET treatment will be&#xD;
      limited to a minimum of 6 sessions and a maximum of 12 sessions, based upon reaching&#xD;
      criterion of 70% symptom improvement as indicated on the PCL-M from baseline or an agreement&#xD;
      between clinician and participant that maximum treatment response has been achieved. All&#xD;
      sessions will be individual and weekly or twice weekly. The first session will last&#xD;
      approximately 90 minutes and will be spent in information gathering, treatment planning, and&#xD;
      explaining the treatment rationale to the patient. Information gathering will review the&#xD;
      history of PTSD and their military service and will include a brief psychosocial history,&#xD;
      including review of prior treatment.&#xD;
&#xD;
      Session 2 will discuss in vivo exposure and construct the hierarchy for in vivo exposure. The&#xD;
      VRET sessions will last 90 minutes each. During VRET sessions patients will wear a&#xD;
      head-mounted display with stereo earphones that will provide visual and audio cues consistent&#xD;
      with Iraqi or Afghan military scenarios or other base-related scenarios as appropriate for&#xD;
      the individual patient. The therapist will make appropriate comments and encourage continued&#xD;
      exposure to the identified index trauma until anxiety has habituated. During exposure,&#xD;
      information will be gathered on the participant's anxiety level through the use of a 0-100&#xD;
      Subjective Units of Discomfort (SUDs) scale. All therapists will have been trained in&#xD;
      Prolonged Imaginal Exposure therapy (PE) followed by training in VRET by Drs. Rothbaum and&#xD;
      Gerardi. Drs. Rothbaum and Gerardi will supervise all therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safely deliverable</measure>
    <time_frame>2 years</time_frame>
    <description>Treatment dropout rates that are similar to existing PE delivered in military samples (20-40%) and by the absence of any critical incidents.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduction in PTSD and depression</measure>
    <time_frame>3 months</time_frame>
    <description>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) following treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduction in PTSD and depression: wait-list comparator</measure>
    <time_frame>6 months</time_frame>
    <description>Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression (PCL-M, CAPS, PHG-9 scores and psychophysiological measures) compared to wait-list results.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Trauma</condition>
  <condition>Post-Traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>VRET Immediate treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized to receive Virtual Reality Exposure Therapy (VRET) immediately</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>6 weeks standard of care, then Virtual Reality Exposure Therapy (VRET) treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual Reality Exposure Therapy (VRET)</intervention_name>
    <description>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.</description>
    <arm_group_label>VRET Immediate treatment</arm_group_label>
    <arm_group_label>Waitlist</arm_group_label>
    <other_name>VRET</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants will be 45 males and females between ages of 18 and 65&#xD;
&#xD;
          -  Participants must meet DSM-V criteria for PTSD due to military sexual trauma (MST)&#xD;
&#xD;
          -  Patients must be literate in English&#xD;
&#xD;
          -  Patients must be medically stable&#xD;
&#xD;
          -  Participants must comprehend his or her role in the study and the risks involved&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of mania, schizophrenia, or other psychoses&#xD;
&#xD;
          -  Patients with active suicidal risk&#xD;
&#xD;
          -  Patients with current alcohol or drug dependence&#xD;
&#xD;
          -  Patients unable to wear the VR head mounted display&#xD;
&#xD;
          -  Patients on psychotropic medications must have been on a stable dose for at least 2&#xD;
             months prior to beginning the study and must agree not to change their current&#xD;
             medication regimen throughout the course of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barbara O Rothbaum, PhD/ABPP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Barbara O. Rothbaum, PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>PTSD</keyword>
  <keyword>Military sexual trauma</keyword>
  <keyword>Veterans</keyword>
  <keyword>Women in the military</keyword>
  <keyword>Sexual assault</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02246972
org study id: IRB00072196
nct id: NCT02246972
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Safely deliverable
time frame: 2 years
description: Treatment dropout rates that are similar to existing PE delivered in military samples (20-40%) and by the absence of any critical incidents.
measure: Reduction in PTSD and depression
time frame: 3 months
description: 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) following treatment.
measure: Reduction in PTSD and depression: wait-list comparator
time frame: 6 months
description: Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression (PCL-M, CAPS, PHG-9 scores and psychophysiological measures) compared to wait-list results.
arm group label: VRET Immediate treatment
arm group type: Experimental
description: Participants will be randomized to receive Virtual Reality Exposure Therapy (VRET) immediately
arm group label: Waitlist
arm group type: Active Comparator
description: 6 weeks standard of care, then Virtual Reality Exposure Therapy (VRET) treatment.
intervention type: Behavioral
intervention name: Virtual Reality Exposure Therapy (VRET)
description: 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.
arm group label: VRET Immediate treatment
arm group label: Waitlist
other name: VRET
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Barbara O Rothbaum, PhD/ABPP
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Barbara O. Rothbaum, PhD
investigator title: Professor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic