<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/NCT02234076</url>
  </required_header>
  <id_info>
    <org_study_id>CI1-12-S028-1</org_study_id>
    <nct_id>NCT02234076</nct_id>
  </id_info>
  <brief_title>A Study on the Efficacy of Virtual Reality Exposure Therapy (VRET) for Survivors of Childhood Sexual Abuse and War Related Trauma</brief_title>
  <official_title>A Study on the Efficacy of Virtual Reality Exposure Therapy (VRET) for Survivors of Childhood Sexual Abuse and War Related Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Netherlands Organisation for Scientific Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Erasmus University Rotterdam</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Delft University of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Amsterdam</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>PsyQ</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Reinier van Arkel Groep, Psychotraumacentrum Zuid-Nederland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Erasmus Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Childhood Sexual Abuse (CSA) and combat related war-trauma are associated with&#xD;
      posttraumatic stress disorder (PTSD) and depression. PTSD is one of the most prevalent&#xD;
      Diagnostic and Statistical Manual of Mental Disorders (DSM) axis 1 disorders for which&#xD;
      psychotherapy is widely practiced. Depression is one of the most common co morbid disorders&#xD;
      when PTSD is diagnosed. Exposure to the traumatic memories or cues of the traumatic event&#xD;
      often plays an important role in reducing symptoms of PTSD. Also symptoms of PTSD and&#xD;
      depression have been related to a reduced specificity in autobiographical memory.&#xD;
&#xD;
      Objective: This study will examine the efficacy of a Virtual Reality Exposure Therapy (VRET)&#xD;
      in a CSA and war related trauma sample by comparing it with treatment as usual (TAU). It will&#xD;
      also attempt to develop protocols to implement this new technology into clinical practice and&#xD;
      collect data to develop a treatment progress prediction model.&#xD;
&#xD;
      Study design: A randomized controlled intervention study.&#xD;
&#xD;
      Study population: 144 individuals with memories of CSA or war related trauma and symptoms of&#xD;
      PTSD and/or depression.&#xD;
&#xD;
      Intervention: VRET or TAU.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">October 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2016</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>Posttraumatic Stress Disorder (PTSD) Checklist Diagnostic &amp; Statistical Manual of Mental Disorders (DSM) 5 (PCL-5) to measure change from baseline self-reported symptoms of PTSD at the endpoint of the therapy (after completing 12 sessions) and follow-ups</measure>
    <time_frame>At pre (baseline), post (after 12 therapy sessions with a minimum of 6 weeks and a maximum of 12 weeks), and follow-up (3 and 12 months post treatment) measurements</time_frame>
    <description>The PCL-5 is a brief assessment that identifies the presence and symptom severity of PTSD. We use the PCL-5 to measure self-reported symptoms of PTSD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Inventory-II (BDI-II) to measure change from baseline self-reported symptoms of depression at the endpoint of the therapy (after completing 12 sessions) and follow-ups</measure>
    <time_frame>At pre (baseline), post (with a minimum of 6 weeks and a maximum of 12 weeks), and follow-up (3 and 12 months post treatment) measurements</time_frame>
    <description>The BDI-II is a self-report questionnaire which measures the severity of depression in 21 statements, with four levels of increasing severity each. We use the BDI-II to measure self-reported symptoms of depression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Outcome Questionnaire-45-2 (OQ-45-2) to measure change from baseline self-reported symptoms and well-being at the endpoint of the therapy (after completing 12 sessions) and follow-ups</measure>
    <time_frame>At pre (baseline), post (with a minimum of 6 weeks and a maximum of 12 weeks) and follow up (3 and 12 months post treatment) measurements</time_frame>
    <description>The OQ-45-2 is a questionnaire which measures well-being in three domains; symptom distress, interpersonal functioning and social role. We use the OQ-45-2 to measure improvement in well-being in participants as addition to the symptom checklists, and to make a useful translation of the research data into clinical practice.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The Positive and Negative Affect Scale (PANAS) to measure change in self-reported emotional progress between therapy sessions</measure>
    <time_frame>Two times per week during 6 weeks</time_frame>
    <description>The PANAS is a self-report questionnaire to measure positive and negative affect. The PANAS measures specific feelings as 'interested', 'inspired' etc. We use the PANAS to measure change in these affects between therapy sessions.</description>
  </other_outcome>
  <other_outcome>
    <measure>The 9-item depression module of the Patient Health Questionnaire (PHQ) to measure self-reported emotional progress between therapy sessions</measure>
    <time_frame>Two times per week during 6 weeks</time_frame>
    <description>The PHQ is a self-report questionnaire which scores the nine DSM-criteria for depression. We use the PHQ to measure change in the nine primary depression symptoms between therapy sessions.</description>
  </other_outcome>
  <other_outcome>
    <measure>The shortened version (6 items) of the PCL-5 to measure change in self-reported emotional progress between therapy sessions</measure>
    <time_frame>Two times per week during 6 weeks</time_frame>
    <description>For general information PCL-5 see primary outcome section. We use 6 items of the PCL-5 to measure self-reported symptoms of PTSD between therapy sessions.</description>
  </other_outcome>
  <other_outcome>
    <measure>The self-report questionnaire Patient's acceptance of a Self-Management health system to asses participants' acceptance of the used technology</measure>
    <time_frame>Post treatment (after 6 weeks)</time_frame>
    <description>The self-report questionnaire Patient's acceptance of a Self-Management health system is a questionnaire to evaluate participants' acceptance of the technology used during the current study. Outcomes are important because they might implicate alterations to strengthen usability of the technology.</description>
  </other_outcome>
  <other_outcome>
    <measure>The Mini International Neuropsychiatric Interview 5.0.0. (MINI 5.0.0.) Dutch version to screen for Diagnostic and Statistical Manual of Mental Disorder (DSM)-IV diagnoses</measure>
    <time_frame>At pre (baseline), post (after 12 therapy sessions with a minimum of 6 weeks and a maximum of 12 weeks), and follow-up (3 and 12 months post treatment) measurements</time_frame>
    <description>The MINI 5.0.0. Dutch version is a semi-structured clinical interview to screen for DSM-IV diagnoses such as PTSD, major depression, bipolar disorder. We use the MINI 5.0.0. Dutch to check in- and exclusion criteria, and to determine change in diagnosis after therapy.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">144</enrollment>
  <condition>Posttraumatic Stress Disorder (PTSD)</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>VRET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Virtual Reality Exposure Therapy (VRET)&#xD;
The experimental treatment VRET is offered with the Multi-Modal Memory Restructuring System (3MR system) and a therapy manual. Participants can use this system at home. Note: The 3MR system is offered via a computer screen, no head-mounted display (HMD) equipment is used in this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment As Usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>VRET</intervention_name>
    <arm_group_label>VRET</arm_group_label>
    <other_name>Virtual Reality Exposure Therapy (VRET)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TAU</intervention_name>
    <description>Treatment as usual offered by the participating mental health care organisations</description>
    <arm_group_label>TAU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  principal diagnosis meeting DSM-IV criteria for PTSD and/or major depression following&#xD;
             CSA or war related trauma&#xD;
&#xD;
          -  between the ages of 18 and 70-years-old&#xD;
&#xD;
          -  having sufficient fluency in Dutch to complete treatment and research protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current bipolar disorder&#xD;
&#xD;
          -  current psychotic disorders&#xD;
&#xD;
          -  current suicidality&#xD;
&#xD;
          -  high dissociation level (Dissociative Experiences Scale (DES) cut-off score ≥ 40)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Marieke van Meggelen, MSc</last_name>
    <phone>0031(0)10-4088689</phone>
    <email>m.vanmeggelen@fsw.eur.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ingmar Franken, full professor</last_name>
    <email>franken@fsw.eur.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Reinier van Arkel Groep PTC ZN</name>
      <address>
        <city>Den Bosch</city>
        <state>Noord-Brabant</state>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marieke van Meggelen, MSc</last_name>
      <phone>0031(0)10-4088689</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>PsyQ</name>
      <address>
        <city>Rotterdam/The Hague</city>
        <state>Zuid-Holland</state>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marieke van Meggelen, MSc</last_name>
      <phone>0031(0)10-4088689</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Erasmus University Rotterdam</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid-Holland</state>
        <zip>3000 DR</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marieke van Meggelen, MSc</last_name>
      <phone>0031(0)10-4088689</phone>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>http://ii.tudelft.nl/vesp/</url>
    <description>Project website</description>
  </link>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>August 16, 2016</last_update_submitted>
  <last_update_submitted_qc>August 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
    <investigator_full_name>Ingmar Franken</investigator_full_name>
    <investigator_title>Professor of Clinical Psychology</investigator_title>
  </responsible_party>
  <keyword>Posttraumatic Stress Disorder</keyword>
  <keyword>Depression</keyword>
  <keyword>Treatment</keyword>
  <keyword>VRET</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>War-Related Injuries</mesh_term>
    <mesh_term>Depression</mesh_term>
    <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/NCT02234076
org study id: CI1-12-S028-1
nct id: NCT02234076
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Background: Childhood Sexual Abuse (CSA) and combat related war-trauma are associated with
      posttraumatic stress disorder (PTSD) and depression. PTSD is one of the most prevalent
      Diagnostic and Statistical Manual of Mental Disorders (DSM) axis 1 disorders for which
      psychotherapy is widely practiced. Depression is one of the most common co morbid disorders
      when PTSD is diagnosed. Exposure to the traumatic memories or cues of the traumatic event
      often plays an important role in reducing symptoms of PTSD. Also symptoms of PTSD and
      depression have been related to a reduced specificity in autobiographical memory.

      Objective: This study will examine the efficacy of a Virtual Reality Exposure Therapy (VRET)
      in a CSA and war related trauma sample by comparing it with treatment as usual (TAU). It will
      also attempt to develop protocols to implement this new technology into clinical practice and
      collect data to develop a treatment progress prediction model.

      Study design: A randomized controlled intervention study.

      Study population: 144 individuals with memories of CSA or war related trauma and symptoms of
      PTSD and/or depression.

      Intervention: VRET or TAU.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Posttraumatic Stress Disorder (PTSD) Checklist Diagnostic & Statistical Manual of Mental Disorders (DSM) 5 (PCL-5) to measure change from baseline self-reported symptoms of PTSD at the endpoint of the therapy (after completing 12 sessions) and follow-ups
time frame: At pre (baseline), post (after 12 therapy sessions with a minimum of 6 weeks and a maximum of 12 weeks), and follow-up (3 and 12 months post treatment) measurements
description: The PCL-5 is a brief assessment that identifies the presence and symptom severity of PTSD. We use the PCL-5 to measure self-reported symptoms of PTSD.
measure: Beck Depression Inventory-II (BDI-II) to measure change from baseline self-reported symptoms of depression at the endpoint of the therapy (after completing 12 sessions) and follow-ups
time frame: At pre (baseline), post (with a minimum of 6 weeks and a maximum of 12 weeks), and follow-up (3 and 12 months post treatment) measurements
description: The BDI-II is a self-report questionnaire which measures the severity of depression in 21 statements, with four levels of increasing severity each. We use the BDI-II to measure self-reported symptoms of depression.
measure: The Outcome Questionnaire-45-2 (OQ-45-2) to measure change from baseline self-reported symptoms and well-being at the endpoint of the therapy (after completing 12 sessions) and follow-ups
time frame: At pre (baseline), post (with a minimum of 6 weeks and a maximum of 12 weeks) and follow up (3 and 12 months post treatment) measurements
description: The OQ-45-2 is a questionnaire which measures well-being in three domains; symptom distress, interpersonal functioning and social role. We use the OQ-45-2 to measure improvement in well-being in participants as addition to the symptom checklists, and to make a useful translation of the research data into clinical practice.
measure: The Positive and Negative Affect Scale (PANAS) to measure change in self-reported emotional progress between therapy sessions
time frame: Two times per week during 6 weeks
description: The PANAS is a self-report questionnaire to measure positive and negative affect. The PANAS measures specific feelings as 'interested', 'inspired' etc. We use the PANAS to measure change in these affects between therapy sessions.
measure: The 9-item depression module of the Patient Health Questionnaire (PHQ) to measure self-reported emotional progress between therapy sessions
time frame: Two times per week during 6 weeks
description: The PHQ is a self-report questionnaire which scores the nine DSM-criteria for depression. We use the PHQ to measure change in the nine primary depression symptoms between therapy sessions.
measure: The shortened version (6 items) of the PCL-5 to measure change in self-reported emotional progress between therapy sessions
time frame: Two times per week during 6 weeks
description: For general information PCL-5 see primary outcome section. We use 6 items of the PCL-5 to measure self-reported symptoms of PTSD between therapy sessions.
measure: The self-report questionnaire Patient's acceptance of a Self-Management health system to asses participants' acceptance of the used technology
time frame: Post treatment (after 6 weeks)
description: The self-report questionnaire Patient's acceptance of a Self-Management health system is a questionnaire to evaluate participants' acceptance of the technology used during the current study. Outcomes are important because they might implicate alterations to strengthen usability of the technology.
measure: The Mini International Neuropsychiatric Interview 5.0.0. (MINI 5.0.0.) Dutch version to screen for Diagnostic and Statistical Manual of Mental Disorder (DSM)-IV diagnoses
time frame: At pre (baseline), post (after 12 therapy sessions with a minimum of 6 weeks and a maximum of 12 weeks), and follow-up (3 and 12 months post treatment) measurements
description: The MINI 5.0.0. Dutch version is a semi-structured clinical interview to screen for DSM-IV diagnoses such as PTSD, major depression, bipolar disorder. We use the MINI 5.0.0. Dutch to check in- and exclusion criteria, and to determine change in diagnosis after therapy.
arm group label: VRET
arm group type: Experimental
description: Virtual Reality Exposure Therapy (VRET)
The experimental treatment VRET is offered with the Multi-Modal Memory Restructuring System (3MR system) and a therapy manual. Participants can use this system at home. Note: The 3MR system is offered via a computer screen, no head-mounted display (HMD) equipment is used in this study.
arm group label: TAU
arm group type: Active Comparator
description: Treatment As Usual
intervention type: Behavioral
intervention name: VRET
arm group label: VRET
other name: Virtual Reality Exposure Therapy (VRET)
intervention type: Behavioral
intervention name: TAU
description: Treatment as usual offered by the participating mental health care organisations
arm group label: TAU
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Marieke van Meggelen, MSc
phone: 0031(0)10-4088689
email: m.vanmeggelen@fsw.eur.nl
last name: Ingmar Franken, full professor
email: franken@fsw.eur.nl
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Netherlands
url: http://ii.tudelft.nl/vesp/
description: Project website
responsible party type: Principal Investigator
investigator affiliation: Erasmus Medical Center
investigator full name: Ingmar Franken
investigator title: Professor of Clinical Psychology
mesh term: War-Related Injuries
mesh term: Depression
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic