<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/NCT01720732</url>
  </required_header>
  <id_info>
    <org_study_id>LL-NET2012</org_study_id>
    <nct_id>NCT01720732</nct_id>
  </id_info>
  <brief_title>Lifeline-NET (Narrative Exposure Therapy): A Short-term Treatment for Traumatized Refugees and Asylum Seekers</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Konstanz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Konstanz</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of a short version of Narrative Exposure Therapy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>PTSD</measure>
    <time_frame>9 months follow up</time_frame>
    <description>Posttraumatic Stress Disorder Clinician Administered PTSD Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Other Symptoms following and related to Trauma, e.g. Depression, Dissociation</measure>
    <time_frame>9 months follow up</time_frame>
    <description>Other Symptoms following and related to Trauma, e.g. Depression, Dissociation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Social functioning, Life Satisfaction, Aggression</measure>
    <time_frame>9 months follow up</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Trauma Treatment</condition>
  <condition>Lifeline NET</condition>
  <condition>Modification of Narrative Exposure Therapy</condition>
  <arm_group>
    <arm_group_label>Lifeline NET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lifeline-NET (Short Version of NET)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment as Usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifeline NET</intervention_name>
    <description>Short Version of Narrative Exposure Therapy</description>
    <arm_group_label>Lifeline NET</arm_group_label>
    <other_name>LL-NET</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PTSD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychotic Disorder,&#xD;
&#xD;
          -  Severe Substance Dependence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Konstanz</name>
      <address>
        <city>Konstanz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.vivo.org/</url>
    <description>NGO</description>
  </link>
  <reference>
    <citation>Schauer M, Neuner F, Elbert T (2005/2011): Narrative Exposure Therapy. A Short-Term Intervention for Traumatic Stress Disorders. 2nd Ed. Cambridge/ Göttingen: Hogrefe &amp; Huber Publishers.</citation>
  </reference>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>December 1, 2014</last_update_submitted>
  <last_update_submitted_qc>December 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Konstanz</investigator_affiliation>
    <investigator_full_name>Martina Ruf</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <!-- 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/NCT01720732
org study id: LL-NET2012
nct id: NCT01720732
lead sponsor: 
has dmc: Yes
Evaluation of a short version of Narrative Exposure Therapy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: PTSD
time frame: 9 months follow up
description: Posttraumatic Stress Disorder Clinician Administered PTSD Scale
measure: Other Symptoms following and related to Trauma, e.g. Depression, Dissociation
time frame: 9 months follow up
description: Other Symptoms following and related to Trauma, e.g. Depression, Dissociation
measure: Social functioning, Life Satisfaction, Aggression
time frame: 9 months follow up
arm group label: Lifeline NET
arm group type: Experimental
description: Lifeline-NET (Short Version of NET)
arm group label: TAU
arm group type: No Intervention
description: Treatment as Usual
intervention type: Behavioral
intervention name: Lifeline NET
description: Short Version of Narrative Exposure Therapy
arm group label: Lifeline NET
other name: LL-NET
criteria: 
gender: All
minimum age: 12 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Germany
url: http://www.vivo.org/
description: NGO
citation: Schauer M, Neuner F, Elbert T (2005/2011): Narrative Exposure Therapy. A Short-Term Intervention for Traumatic Stress Disorders. 2nd Ed. Cambridge/ Göttingen: Hogrefe & Huber Publishers.
responsible party type: Principal Investigator
investigator affiliation: University of Konstanz
investigator full name: Martina Ruf
investigator title: PhD