<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/NCT02242136</url>
  </required_header>
  <id_info>
    <org_study_id>UKULBU2014</org_study_id>
    <nct_id>NCT02242136</nct_id>
  </id_info>
  <brief_title>Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants</brief_title>
  <official_title>Formation, Orientation and Rehabilitation by Means of Narrative Exposure Therapy (FORNET) for Returning Soldiers of the African Union Mission to Somalia, Male and Female Ex-combatants in Burundi</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Konstanz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Université Lumière de Bujumbura</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <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 deployed in peace-keeping missions as well as ex-combatants in conflict or former&#xD;
      conflict regions were and are often exposed to multiple traumatic events and situations in&#xD;
      which they are forced to engage in violent behavior. The treatment program Formation,&#xD;
      Orientation and Rehabilitation by means of Narrative Exposure Therapy (FORNET) is a&#xD;
      short-term, culturally sensitive treatment approach that aims to reduce Posttraumatic Stress&#xD;
      Disorder (PTSD) symptoms as well as the risk to engage in uncontrolled violent behavior.&#xD;
      Addressing trauma-related mental disorders as well as emotions related to aggression by means&#xD;
      of FORNET is expected to facilitate reintegration in civil life and reduce uncontrolled&#xD;
      violence.&#xD;
&#xD;
      The investigators want to provide evidence, that FORNET is an effective and efficient module&#xD;
      to assist soldiers after deployment in Somalia and/or male and female ex-combatants who&#xD;
      fought in the civil war in Burundi. In addition the investigators aim to explore how&#xD;
      traumatic incidences and maltreatment during childhood may influence treatment outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Diagnosis and load of PTSD symptoms assessed via the Posttraumatic Symptom Scale - Interview (PSS-I)</measure>
    <time_frame>baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in the extend of appetitive aggression assessed via the Appetitive Aggression Scale (AAS)</measure>
    <time_frame>baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in number of committed violent acts during the past three months assessed via the Domestic and Community Violence Checklist (DCVC)</measure>
    <time_frame>baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in load of depressive symptoms assessed via the Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in strength of suicidal ideation measured via the Mini International Neuropsychiatric Interview (M.I.N.I.)</measure>
    <time_frame>baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical health complains</measure>
    <time_frame>baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Posttraumatic Stress Disorder</condition>
  <condition>Aggressive Behavior</condition>
  <condition>Appetitive Aggression</condition>
  <arm_group>
    <arm_group_label>FORNET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During FORNET, the client, with the assistance of the therapist, constructs a chronological narrative of his or her entire life with a focus on exposure to traumatic stress and committed violence. Empathic understanding, active listening, congruency and unconditional positive regard are key components of the therapist's behavior. The therapist asks in detail for the client's emotions, cognitions, physiological reactions, and sensory informations during traumatic and aggressive events to link them to an autobiographical context, namely time and place. In total the individuals receive 8 sessions of FORNET, every session lasting between 1,5 and 2 hrs depending on the needs of the participant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting list</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>FORNET</intervention_name>
    <arm_group_label>FORNET</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  High degree of symptoms of posttraumatic stress disorder according to the&#xD;
             Posttraumatic Symptom Scale,&#xD;
&#xD;
          -  High degree of appetitive aggression,&#xD;
&#xD;
          -  Violent behavior during the past three months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current use of mind altering drugs,&#xD;
&#xD;
          -  Psychotic symptoms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anselm Crombach, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Konstanz</affiliation>
  </overall_official>
  <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>November 2017</verification_date>
  <study_first_submitted>September 14, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>November 27, 2017</last_update_submitted>
  <last_update_submitted_qc>November 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2017</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>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Posttraumatic Stress Disorder</keyword>
  <keyword>Aggressive Behavior</keyword>
  <keyword>Appetitive Aggression</keyword>
  <keyword>Treatment</keyword>
  <keyword>FORNET</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/NCT02242136
org study id: UKULBU2014
nct id: NCT02242136
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Soldiers deployed in peace-keeping missions as well as ex-combatants in conflict or former
      conflict regions were and are often exposed to multiple traumatic events and situations in
      which they are forced to engage in violent behavior. The treatment program Formation,
      Orientation and Rehabilitation by means of Narrative Exposure Therapy (FORNET) is a
      short-term, culturally sensitive treatment approach that aims to reduce Posttraumatic Stress
      Disorder (PTSD) symptoms as well as the risk to engage in uncontrolled violent behavior.
      Addressing trauma-related mental disorders as well as emotions related to aggression by means
      of FORNET is expected to facilitate reintegration in civil life and reduce uncontrolled
      violence.

      The investigators want to provide evidence, that FORNET is an effective and efficient module
      to assist soldiers after deployment in Somalia and/or male and female ex-combatants who
      fought in the civil war in Burundi. In addition the investigators aim to explore how
      traumatic incidences and maltreatment during childhood may influence treatment outcomes.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Diagnosis and load of PTSD symptoms assessed via the Posttraumatic Symptom Scale - Interview (PSS-I)
time frame: baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.
measure: Change from baseline in the extend of appetitive aggression assessed via the Appetitive Aggression Scale (AAS)
time frame: baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.
measure: Change in number of committed violent acts during the past three months assessed via the Domestic and Community Violence Checklist (DCVC)
time frame: baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.
measure: Change from baseline in load of depressive symptoms assessed via the Patient Health Questionnaire-9 (PHQ-9)
time frame: baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.
measure: Change in strength of suicidal ideation measured via the Mini International Neuropsychiatric Interview (M.I.N.I.)
time frame: baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.
measure: Change in physical health complains
time frame: baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.
arm group label: FORNET
arm group type: Experimental
description: During FORNET, the client, with the assistance of the therapist, constructs a chronological narrative of his or her entire life with a focus on exposure to traumatic stress and committed violence. Empathic understanding, active listening, congruency and unconditional positive regard are key components of the therapist's behavior. The therapist asks in detail for the client's emotions, cognitions, physiological reactions, and sensory informations during traumatic and aggressive events to link them to an autobiographical context, namely time and place. In total the individuals receive 8 sessions of FORNET, every session lasting between 1,5 and 2 hrs depending on the needs of the participant.
arm group label: Waiting list
arm group type: No Intervention
intervention type: Behavioral
intervention name: FORNET
arm group label: FORNET
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Anselm Crombach, Dr.
role: Principal Investigator
affiliation: University of Konstanz
facility: 
country: Burundi
responsible party type: Principal Investigator
investigator affiliation: University of Konstanz
investigator full name: Anselm Crombach
investigator title: Principal Investigator
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
mesh term: Aggression