<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/NCT02989987</url>
  </required_header>
  <id_info>
    <org_study_id>SGBV1617</org_study_id>
    <nct_id>NCT02989987</nct_id>
  </id_info>
  <brief_title>NET for SGBV Survivors in Eastern DR Congo</brief_title>
  <official_title>Narrative Exposure Therapy for Survivors of Sexual and Gender Based Violence in Eastern DR Congo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Konstanz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vivo international e.V.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Konstanz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Throughout the last 10 years Narrative Exposure Therapy (NET) has evolved as one of the most&#xD;
      effective, culturally sensitive trauma interventions. In the present study the effectiveness&#xD;
      of NET delivered by trained health personnel in a sample of survivors of sexual and gender&#xD;
      based violence (SGBV) who suffer from Posttraumatic Stress Disorder (PTSD) will be assessed.&#xD;
      Structured baseline, 3 and 6 month follow up interviews will be administered to assess the&#xD;
      main outcome measures PTSD and shame. The trial will take place in Goma, DR Congo, where SGBV&#xD;
      and its sequelae has been a major problem.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be recruited through local NGOs and eligible clients randomized to the&#xD;
      treatment (NET; app. N=100) or treatment-as-usual control (app. N=100) group, respectively.&#xD;
      At baseline, 3-month and 6-month post-treatment, sociodemographic data, trauma exposure -&#xD;
      esp. SGBV, PTSD, dissociation, shame, functionality and depression will be assessed in a&#xD;
      structured interview. The interviews will be conducted by blind Congolese psychological&#xD;
      interviewers after an intensive 3-weeks training and continuous supervision.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">April 3, 2019</completion_date>
  <primary_completion_date type="Actual">April 3, 2019</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PSS-I: Posttraumatic Stress Disorder symptom severity (sumscore and diagnosis)</measure>
    <time_frame>Change from baseline to 3 and 6 months post treatment</time_frame>
    <description>PTSD Symptom Scale - Interview (PSS-I; Foa &amp; Tolin, 2000)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SVQ: Severity of shame (sumscore)</measure>
    <time_frame>Change from baseline to 3 and 6 months post treatment</time_frame>
    <description>Shame Variability Questionnaire (Brown, Rizvi &amp; Linehan, unpublished)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ShutD: Severity of Shutdown Dissociation Symptoms (sumscore)</measure>
    <time_frame>Change from baseline to 3 and 6 months post treatment</time_frame>
    <description>Shutdown Dissociation Scale (Schalinski et al., 2015)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PHQ: Depression symptom severity (sumscore)</measure>
    <time_frame>Change in 3 and 6 months post treatment</time_frame>
    <description>Patient Health Questionnaire - 9 (PHQ-9; Kroenke &amp; Spitzer, 2002)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functionality (sumscore)</measure>
    <time_frame>3 and 6 months post treatment</time_frame>
    <description>Local Functionality Index (LFI; Bass et al., 2013)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">201</enrollment>
  <condition>Posttraumatic Stress Disorder</condition>
  <condition>Shame</condition>
  <arm_group>
    <arm_group_label>Narrative Exposure Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>According to the NET manual (one lifeline session and 7 exposure sessions; see Schauer et al. 2011).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment-as-usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Social support (provided on demand)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Narrative Exposure Therapy</intervention_name>
    <arm_group_label>Narrative Exposure Therapy</arm_group_label>
    <other_name>NET</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social Support</intervention_name>
    <description>A local counselors provides social support on demand.</description>
    <arm_group_label>Treatment-as-usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  SGBV survivors (event happened more than 4 weeks ago)&#xD;
&#xD;
          -  PTSD diagnosis (DSM-5)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute psychosis&#xD;
&#xD;
          -  Signs of cerebro-organic disease&#xD;
&#xD;
          -  Acute drug or alcohol intoxication&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Konstanz</name>
      <address>
        <city>Konstanz</city>
        <state>BW</state>
        <zip>78464</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Schauer, M., Schauer, M., Neuner, F., &amp; Elbert, T. (2011). Narrative exposure therapy: A short-term treatment for traumatic stress disorders. Hogrefe Publishing.</citation>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>September 30, 2019</last_update_submitted>
  <last_update_submitted_qc>September 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Konstanz</investigator_affiliation>
    <investigator_full_name>Anke Köbach</investigator_full_name>
    <investigator_title>Postdoctoral Researcher</investigator_title>
  </responsible_party>
  <keyword>PTSD</keyword>
  <keyword>Shame</keyword>
  <keyword>Narrative Exposure Therapy</keyword>
  <keyword>Sexual and gender based violence (SGBV)</keyword>
  <keyword>DR Congo</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02989987
org study id: SGBV1617
nct id: NCT02989987
lead sponsor: 
collaborator: 
has dmc: No
Throughout the last 10 years Narrative Exposure Therapy (NET) has evolved as one of the most
      effective, culturally sensitive trauma interventions. In the present study the effectiveness
      of NET delivered by trained health personnel in a sample of survivors of sexual and gender
      based violence (SGBV) who suffer from Posttraumatic Stress Disorder (PTSD) will be assessed.
      Structured baseline, 3 and 6 month follow up interviews will be administered to assess the
      main outcome measures PTSD and shame. The trial will take place in Goma, DR Congo, where SGBV
      and its sequelae has been a major problem.
Participants will be recruited through local NGOs and eligible clients randomized to the
      treatment (NET; app. N=100) or treatment-as-usual control (app. N=100) group, respectively.
      At baseline, 3-month and 6-month post-treatment, sociodemographic data, trauma exposure -
      esp. SGBV, PTSD, dissociation, shame, functionality and depression will be assessed in a
      structured interview. The interviews will be conducted by blind Congolese psychological
      interviewers after an intensive 3-weeks training and continuous supervision.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: PSS-I: Posttraumatic Stress Disorder symptom severity (sumscore and diagnosis)
time frame: Change from baseline to 3 and 6 months post treatment
description: PTSD Symptom Scale - Interview (PSS-I; Foa & Tolin, 2000)
measure: SVQ: Severity of shame (sumscore)
time frame: Change from baseline to 3 and 6 months post treatment
description: Shame Variability Questionnaire (Brown, Rizvi & Linehan, unpublished)
measure: ShutD: Severity of Shutdown Dissociation Symptoms (sumscore)
time frame: Change from baseline to 3 and 6 months post treatment
description: Shutdown Dissociation Scale (Schalinski et al., 2015)
measure: PHQ: Depression symptom severity (sumscore)
time frame: Change in 3 and 6 months post treatment
description: Patient Health Questionnaire - 9 (PHQ-9; Kroenke & Spitzer, 2002)
measure: Functionality (sumscore)
time frame: 3 and 6 months post treatment
description: Local Functionality Index (LFI; Bass et al., 2013)
arm group label: Narrative Exposure Therapy
arm group type: Active Comparator
description: According to the NET manual (one lifeline session and 7 exposure sessions; see Schauer et al. 2011).
arm group label: Treatment-as-usual
arm group type: Active Comparator
description: Social support (provided on demand)
intervention type: Behavioral
intervention name: Narrative Exposure Therapy
arm group label: Narrative Exposure Therapy
other name: NET
intervention type: Behavioral
intervention name: Social Support
description: A local counselors provides social support on demand.
arm group label: Treatment-as-usual
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Germany
citation: Schauer, M., Schauer, M., Neuner, F., & Elbert, T. (2011). Narrative exposure therapy: A short-term treatment for traumatic stress disorders. Hogrefe Publishing.
responsible party type: Principal Investigator
investigator affiliation: University of Konstanz
investigator full name: Anke Köbach
investigator title: Postdoctoral Researcher
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: Undecided