<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/NCT01729325</url>
  </required_header>
  <id_info>
    <org_study_id>UKULBUSO2012</org_study_id>
    <nct_id>NCT01729325</nct_id>
  </id_info>
  <brief_title>Prevention of Post-Traumatic Stress Disorder in Soldiers</brief_title>
  <official_title>Prevention of Post-Traumatic Stress Disorder in Relation to Appetitive Aggression in Burundian Soldiers Deployed in a Peace-keeping Mission in Somalia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Konstanz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Volkswagen Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Konstanz</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Soldiers in conflict or former conflict regions deployed in peace-keeping missions were and&#xD;
      are often exposed to multiple traumatic events and situations in which they are forced to&#xD;
      engage in violent behavior. The Preventive Narrative Exposure Therapy (Pre-NET) aims to&#xD;
      reinforce resilience thereby reducing the risk of developing or aggravating PTSD or other&#xD;
      mental disorders as a result of traumatic experiences. The effective prevention of mental&#xD;
      disorders as a result of war deployment is expected to facilitate reintegration in civil life&#xD;
      after deployment and reduce uncontrolled violence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Severity of traumatic symptoms measured via the Post-traumatic Stress Disorder Scale-Interview (PSS-I)</measure>
    <time_frame>15 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Extend of appetitive aggression via the Appetitive Aggressions Scale (AAS)</measure>
    <time_frame>15 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of depressive symptoms measured via the Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>15 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength of suicidal ideation measured via the MINI</measure>
    <time_frame>15 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical health complains</measure>
    <time_frame>15 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Post-traumatic Stress Disorder (PTSD)</condition>
  <condition>Aggressive Behavior</condition>
  <arm_group>
    <arm_group_label>Preventive Narrative Exposure Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with Pre-NET before deployment in peace-keeping mission</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No treatment control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Preventive Narrative Exposure Therapy</intervention_name>
    <description>During Pre-NET the client, with the assistance of the therapist, constructs a chronological narrative of his whole life with a focus on exposure to traumatic stress. Empathic understanding, active listening, congruency and unconditional positive regard are key components of the therapist's behavior who asks in detail for emotions, cognitions, sensory information, and physiological reactions, linking them to an autobiographical context. During two sessions a chronological overview of the whole life with a focus on traumatic events is developed and the most important traumatic experiences are processed.</description>
    <arm_group_label>Preventive Narrative Exposure Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Exposure to traumatic experiences derived from expert interviews with scores of the&#xD;
             Traumatic Life Event List for War and Torture&#xD;
&#xD;
          -  Soldiers are part of the Burundian army and of the joint African Union and United&#xD;
             Nations peacekeeping mission in Somalia (AMISOM)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current use of mind altering drugs&#xD;
&#xD;
          -  Psychotic symptoms&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Burundian Army (FDN)</name>
      <address>
        <city>Bujumbura</city>
        <country>Burundi</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Burundi</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>June 2, 2015</last_update_submitted>
  <last_update_submitted_qc>June 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Konstanz</investigator_affiliation>
    <investigator_full_name>Anselm Crombach</investigator_full_name>
    <investigator_title>Dipl.-Psych.</investigator_title>
  </responsible_party>
  <keyword>Post-traumatic Stress disorder (PTSD)</keyword>
  <keyword>Aggressive Behavior</keyword>
  <keyword>Appetitive Aggression</keyword>
  <keyword>Resilience</keyword>
  <keyword>Preventive Narrative Exposure Therapy</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>
    <mesh_term>Aggression</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/NCT01729325
org study id: UKULBUSO2012
nct id: NCT01729325
lead sponsor: 
collaborator: 
has dmc: Yes
Soldiers in conflict or former conflict regions deployed in peace-keeping missions were and
      are often exposed to multiple traumatic events and situations in which they are forced to
      engage in violent behavior. The Preventive Narrative Exposure Therapy (Pre-NET) aims to
      reinforce resilience thereby reducing the risk of developing or aggravating PTSD or other
      mental disorders as a result of traumatic experiences. The effective prevention of mental
      disorders as a result of war deployment is expected to facilitate reintegration in civil life
      after deployment and reduce uncontrolled violence.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Severity of traumatic symptoms measured via the Post-traumatic Stress Disorder Scale-Interview (PSS-I)
time frame: 15 months
measure: Extend of appetitive aggression via the Appetitive Aggressions Scale (AAS)
time frame: 15 months
measure: Severity of depressive symptoms measured via the Patient Health Questionnaire-9 (PHQ-9)
time frame: 15 months
measure: Strength of suicidal ideation measured via the MINI
time frame: 15 months
measure: Physical health complains
time frame: 15 months
arm group label: Preventive Narrative Exposure Therapy
arm group type: Experimental
description: Treatment with Pre-NET before deployment in peace-keeping mission
arm group label: No treatment control
arm group type: No Intervention
intervention type: Behavioral
intervention name: Preventive Narrative Exposure Therapy
description: During Pre-NET the client, with the assistance of the therapist, constructs a chronological narrative of his whole life with a focus on exposure to traumatic stress. Empathic understanding, active listening, congruency and unconditional positive regard are key components of the therapist's behavior who asks in detail for emotions, cognitions, sensory information, and physiological reactions, linking them to an autobiographical context. During two sessions a chronological overview of the whole life with a focus on traumatic events is developed and the most important traumatic experiences are processed.
arm group label: Preventive Narrative Exposure Therapy
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Burundi
responsible party type: Principal Investigator
investigator affiliation: University of Konstanz
investigator full name: Anselm Crombach
investigator title: Dipl.-Psych.
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
mesh term: Aggression