<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/NCT03000478</url>
  </required_header>
  <id_info>
    <org_study_id>BIU201216</org_study_id>
    <nct_id>NCT03000478</nct_id>
  </id_info>
  <brief_title>Virtual Reality Exposure Therapy for Combat</brief_title>
  <acronym>VRET</acronym>
  <official_title>Virtual Reality Treatment for Combat Related PTSD: Is Virtual Azza More Effective Than Traditional Exposure Treatment?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bar-Ilan University, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bar-Ilan University, Israel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This non inferiority trial will compare Prolonged Exposure with Virtual Reality Exposure&#xD;
      Therapy in adult patients with combat related PTSD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Posttraumatic stress disorder (PTSD) affects a significant number of combat soldiers, with&#xD;
      some studies suggesting 20% have PTSD. PTSD is related to a number of other detrimental&#xD;
      effects, on the individual, such as mood disorders and alcohol abuse, on family members, and&#xD;
      on society at large. Although effective treatments for PTSD exist, primarily types of&#xD;
      cognitive behavior therapy, their uptake is very low. Studies have shown that a variety of&#xD;
      factors act as barriers to care. These include not having the time for therapy, no therapy&#xD;
      being locally available, and general stigma about therapy. In military populations, this&#xD;
      stigma includes worries about the attitudes of unit members and commanding officers. As a&#xD;
      result, many combat veterans do not seek therapy. Recently, it has been suggested that&#xD;
      providing therapy in non-conventional settings might overcome some of these barriers. Studies&#xD;
      over the last decade have shown that using Virtual Reality is a potential option. Virtual&#xD;
      reality is a computer based environment that allows the therapist complete control over its&#xD;
      multimedia components. VR is easily adaptable to exposure based treatments, where patients&#xD;
      gradually come into contact with feared situations. VR for PTSD following combat, terror and&#xD;
      motor vehicle accidents have all shown to be effective treatments. The studies so far are&#xD;
      few, involve a small number of patients, and have often not adhered to gold standards of&#xD;
      controlled trials. In addition, VR for combat in Israel has never been developed or tested.&#xD;
&#xD;
      The current study is a randomized controlled trial, that will compare traditional&#xD;
      face-to-face treatment with Virtual Reality, for combat related PTSD. Blind assessors will&#xD;
      examine levels of PTSD and other disorders before treatment, immediately after treatment, and&#xD;
      at 6 month follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PTSD symptoms</measure>
    <time_frame>6 months post treatment</time_frame>
    <description>PTSD as measured by the CAPS</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>PTSD</condition>
  <arm_group>
    <arm_group_label>Prolonged Exposure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 sessions of PE as per protocol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VRET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 sessions of Virtual Reality Exposure Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Prolonged Exposure</intervention_name>
    <arm_group_label>Prolonged Exposure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual Reality Exposure Therapy</intervention_name>
    <arm_group_label>VRET</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  combat related PTSD; Hebrew first language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  suicidality, other psychiatric diagnosis requiring treatment, concurrent treatment,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sara Freedman, PhD</last_name>
    <phone>544704636</phone>
    <email>sarafreedman@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Bar Ilan University</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52900</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sara Freedman, PhD</last_name>
      <phone>544704636</phone>
      <email>sarafreedman@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>February 15, 2018</last_update_submitted>
  <last_update_submitted_qc>February 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bar-Ilan University, Israel</investigator_affiliation>
    <investigator_full_name>Sara Freedman</investigator_full_name>
    <investigator_title>Dr. Sara Freedman</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03000478
org study id: BIU201216
nct id: NCT03000478
lead sponsor: 
has dmc: No
This non inferiority trial will compare Prolonged Exposure with Virtual Reality Exposure
      Therapy in adult patients with combat related PTSD.
Posttraumatic stress disorder (PTSD) affects a significant number of combat soldiers, with
      some studies suggesting 20% have PTSD. PTSD is related to a number of other detrimental
      effects, on the individual, such as mood disorders and alcohol abuse, on family members, and
      on society at large. Although effective treatments for PTSD exist, primarily types of
      cognitive behavior therapy, their uptake is very low. Studies have shown that a variety of
      factors act as barriers to care. These include not having the time for therapy, no therapy
      being locally available, and general stigma about therapy. In military populations, this
      stigma includes worries about the attitudes of unit members and commanding officers. As a
      result, many combat veterans do not seek therapy. Recently, it has been suggested that
      providing therapy in non-conventional settings might overcome some of these barriers. Studies
      over the last decade have shown that using Virtual Reality is a potential option. Virtual
      reality is a computer based environment that allows the therapist complete control over its
      multimedia components. VR is easily adaptable to exposure based treatments, where patients
      gradually come into contact with feared situations. VR for PTSD following combat, terror and
      motor vehicle accidents have all shown to be effective treatments. The studies so far are
      few, involve a small number of patients, and have often not adhered to gold standards of
      controlled trials. In addition, VR for combat in Israel has never been developed or tested.

      The current study is a randomized controlled trial, that will compare traditional
      face-to-face treatment with Virtual Reality, for combat related PTSD. Blind assessors will
      examine levels of PTSD and other disorders before treatment, immediately after treatment, and
      at 6 month follow up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PTSD symptoms
time frame: 6 months post treatment
description: PTSD as measured by the CAPS
arm group label: Prolonged Exposure
arm group type: Active Comparator
description: 12 sessions of PE as per protocol
arm group label: VRET
arm group type: Experimental
description: 12 sessions of Virtual Reality Exposure Therapy
intervention type: Behavioral
intervention name: Prolonged Exposure
arm group label: Prolonged Exposure
intervention type: Behavioral
intervention name: Virtual Reality Exposure Therapy
arm group label: VRET
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sara Freedman, PhD
phone: 544704636
email: sarafreedman@gmail.com
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Bar-Ilan University, Israel
investigator full name: Sara Freedman
investigator title: Dr. Sara Freedman
sharing ipd: No