<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/NCT02992561</url>
  </required_header>
  <id_info>
    <org_study_id>FORNET1617</org_study_id>
    <nct_id>NCT02992561</nct_id>
  </id_info>
  <brief_title>Addressing Heightened Levels of Aggression in Traumatized Offenders With Psychotherapeutic Means</brief_title>
  <official_title>Addressing Heightened Levels of Aggression in Traumatized Offenders With Psychotherapeutic Means: A Randomized Controlled Trial in Eastern DR Congo</official_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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Heightened levels of aggression are fuelling violent incidents at all levels, especially in&#xD;
      post-war regions. Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET)&#xD;
      aims to address trauma symptoms along with reactive and instrumental/appetitive aggression to&#xD;
      encounter the downward cycle of perpetration and enforce a sustainable (re-)integration into&#xD;
      civil life. In the present study, the investigators provide an adapted version of FORNET to&#xD;
      former combatants in the North Kivu, Eastern DR Congo. Structured baseline, 3 and 6 month&#xD;
      follow up interviews will be administered to assess the main outcome measures recent violent&#xD;
      acts and appetitive aggression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be recruited through local NGOs and eligible clients randomized to the&#xD;
      treatment or waitlist control group, respectively. The treatment will be provided by&#xD;
      supervised local counsellors after a 4-week training. At baseline, 3-month and 6-month follow&#xD;
      up, sociodemographic data, trauma exposure, perpetrated violent acts, PTSD, recent&#xD;
      aggression, functionality and drug dependency will be assessed. The interviews will be&#xD;
      conducted by blind Congolese psychological interviewers after an intensive 3-weeks training&#xD;
      and continuous supervision.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">March 2019</completion_date>
  <primary_completion_date type="Actual">March 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>Appetitive aggression (sumscore; 0-60 indicating higher levels)</measure>
    <time_frame>Change from baseline to 3-5 and 6-9 months post treatment</time_frame>
    <description>Appetitive Aggression Scale (Weierstall &amp; Ebert, 2011)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Current violent behavior (sumscore; 0-96 indicating more acts)</measure>
    <time_frame>Change from baseline to 3-5 and 6-9 months post treatment</time_frame>
    <description>A list of violent offenses perpetrated during the last 3 months (formerly used in Burundi; Crombach/Augsburger/Nandi)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PSS-I: Posttraumatic Stress Disorder (sumscore, 0-80 indicating higher severity)</measure>
    <time_frame>Change from baseline to 3-5 and 6-9 months post treatment</time_frame>
    <description>PTSD Symptom Scale (Foa &amp; Tolin, 2000)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Social acknowledgement (0-45 indicating more social acknowledgment)</measure>
    <time_frame>Change from baseline to 3-5 and 6-9 months post treatment</time_frame>
    <description>Social Acknowledgement Questionnaire (Maerker &amp; Mueller, 2004)</description>
  </other_outcome>
  <other_outcome>
    <measure>Depression (0-27 indicating higher severity)</measure>
    <time_frame>Change from baseline to 3-5 and 6-9 months post treatment</time_frame>
    <description>Patient Health Questionnaire - 9 (Kroenke &amp; Spitzer, 2002)</description>
  </other_outcome>
  <other_outcome>
    <measure>Substance use problems</measure>
    <time_frame>Change from baseline to 3-5 and 6-9 months post treatment</time_frame>
    <description>Alcohol, Smoking and Substance Involvement Screening Test (Humeniuk et al., 2008)</description>
  </other_outcome>
  <other_outcome>
    <measure>Epigenetic changes</measure>
    <time_frame>Change from baseline to 6-9 month post treatment</time_frame>
    <description>Genome wide methylation patterns (to be explored)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">402</enrollment>
  <condition>Appetitive Aggression</condition>
  <arm_group>
    <arm_group_label>Narrative Exposure Therapy (FORNET, adapted version)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Version of Narrative Exposure Therapy for Forensic Offender Rehabilitation including one lifeline session and 5 exposure sessions as well as 6 group sessions adapted from behavioral-therapy approaches for addiction problems.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist control or treatment as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention or non-specific measures of support on request</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>FORNET (adapted version)</intervention_name>
    <arm_group_label>Narrative Exposure Therapy (FORNET, adapted version)</arm_group_label>
    <other_name>Narrative Exposure Therapy for Forensic Offender Rehabilitation (adapted version)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Eligibility criteria&#xD;
&#xD;
          -  Former participant of an armed group in DR Congo&#xD;
&#xD;
          -  Involvement in violent attacks&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  PTSD diagnosis or AAS sum score of 22 or higher&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute intoxification (alcohol or other drugs)&#xD;
&#xD;
          -  Acute psychotic symptoms&#xD;
&#xD;
          -  Sign of cerebro-organic diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anke Köbach, PI</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Konstanz</affiliation>
  </overall_official>
  <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>
  <link>
    <url>https://doi.org/10.1016/j.brat.2019.103482</url>
    <description>Results for the group of female former child soldiers</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 10, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</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>Aggression</keyword>
  <keyword>Violence</keyword>
  <keyword>Post-conflict reconstruction</keyword>
  <keyword>Demobilization</keyword>
  <keyword>Traumatized offenders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aggression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02992561
org study id: FORNET1617
nct id: NCT02992561
lead sponsor: 
has dmc: No
Heightened levels of aggression are fuelling violent incidents at all levels, especially in
      post-war regions. Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET)
      aims to address trauma symptoms along with reactive and instrumental/appetitive aggression to
      encounter the downward cycle of perpetration and enforce a sustainable (re-)integration into
      civil life. In the present study, the investigators provide an adapted version of FORNET to
      former combatants in the North Kivu, Eastern DR Congo. Structured baseline, 3 and 6 month
      follow up interviews will be administered to assess the main outcome measures recent violent
      acts and appetitive aggression.
Participants will be recruited through local NGOs and eligible clients randomized to the
      treatment or waitlist control group, respectively. The treatment will be provided by
      supervised local counsellors after a 4-week training. At baseline, 3-month and 6-month follow
      up, sociodemographic data, trauma exposure, perpetrated violent acts, PTSD, recent
      aggression, functionality and drug dependency will be assessed. 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: Appetitive aggression (sumscore; 0-60 indicating higher levels)
time frame: Change from baseline to 3-5 and 6-9 months post treatment
description: Appetitive Aggression Scale (Weierstall & Ebert, 2011)
measure: Current violent behavior (sumscore; 0-96 indicating more acts)
time frame: Change from baseline to 3-5 and 6-9 months post treatment
description: A list of violent offenses perpetrated during the last 3 months (formerly used in Burundi; Crombach/Augsburger/Nandi)
measure: PSS-I: Posttraumatic Stress Disorder (sumscore, 0-80 indicating higher severity)
time frame: Change from baseline to 3-5 and 6-9 months post treatment
description: PTSD Symptom Scale (Foa & Tolin, 2000)
measure: Social acknowledgement (0-45 indicating more social acknowledgment)
time frame: Change from baseline to 3-5 and 6-9 months post treatment
description: Social Acknowledgement Questionnaire (Maerker & Mueller, 2004)
measure: Depression (0-27 indicating higher severity)
time frame: Change from baseline to 3-5 and 6-9 months post treatment
description: Patient Health Questionnaire - 9 (Kroenke & Spitzer, 2002)
measure: Substance use problems
time frame: Change from baseline to 3-5 and 6-9 months post treatment
description: Alcohol, Smoking and Substance Involvement Screening Test (Humeniuk et al., 2008)
measure: Epigenetic changes
time frame: Change from baseline to 6-9 month post treatment
description: Genome wide methylation patterns (to be explored)
arm group label: Narrative Exposure Therapy (FORNET, adapted version)
arm group type: Active Comparator
description: Version of Narrative Exposure Therapy for Forensic Offender Rehabilitation including one lifeline session and 5 exposure sessions as well as 6 group sessions adapted from behavioral-therapy approaches for addiction problems.
arm group label: Waitlist control or treatment as usual
arm group type: No Intervention
description: No intervention or non-specific measures of support on request
intervention type: Behavioral
intervention name: FORNET (adapted version)
arm group label: Narrative Exposure Therapy (FORNET, adapted version)
other name: Narrative Exposure Therapy for Forensic Offender Rehabilitation (adapted version)
criteria: 
gender: All
minimum age: 16 Years
maximum age: 80 Years
healthy volunteers: No
last name: Anke Köbach, PI
role: Principal Investigator
affiliation: University of Konstanz
facility: 
country: Germany
url: https://doi.org/10.1016/j.brat.2019.103482
description: Results for the group of female former child soldiers
responsible party type: Principal Investigator
investigator affiliation: University of Konstanz
investigator full name: Anke Köbach
investigator title: Postdoctoral Researcher
mesh term: Aggression
sharing ipd: No