<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/NCT02259530</url>
  </required_header>
  <id_info>
    <org_study_id>01DG13020_a</org_study_id>
    <nct_id>NCT02259530</nct_id>
  </id_info>
  <brief_title>Case Series for Traumatized Refugees With Khat Dependence</brief_title>
  <official_title>Sustainable and Adapted Treatment Strategies to Restore Psychological Functioning and Mental Health Among Displaced Somalis: Preparation of a Multicenter Treatment Study (P114/02/2014): Pilot Study 3.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Konstanz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Africa Mental Health Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Konstanz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The research project will offer psychotherapeutic treatment to Somali refugees with PTSD and&#xD;
      comorbid khat dependence. In this case series, evidence-based techniques will be applied and&#xD;
      adapted to the cultural background of Somali refugees in Kenya.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      More than 500.000 Somali refugees live in Kenya. This group is especially burdened by high&#xD;
      rates of exposure to traumatic events, high prevalence of PTSD and a high comorbidity with&#xD;
      substance use disorders, mainly related to khat (catha edulis). There's a shortage of&#xD;
      literature on psychotherapeutic methods that are applicable in this group. The aim of this&#xD;
      case series is to develop modifications of standard therapeutic techniques to the Somali&#xD;
      culture and to the needs of this group. Twenty successive cases will be recruited from a&#xD;
      community clinic where refugees often seek for treatment because of psychiatric problems.&#xD;
      Senior level psychotherapists will apply and adapt techniques and approaches like Community&#xD;
      Reinforcement Approach (CRA), Relapse Prevention (RP), and Narrative Exposure Therapy (NET);&#xD;
      all sessions will be video recorded. Regular supervision with external experts and group&#xD;
      discussions will be held to evaluate and adapt the single procedures and techniques. The aim&#xD;
      of this study is the development of a standardized approach that can be used in a Randomized&#xD;
      Controlled Trial which will be conduced in the future.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Posttraumatic Stress Diagnostic Scale (PDS)</measure>
    <time_frame>3 months</time_frame>
    <description>Pre-post change of self-reported PTSD-symptom severity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time-Line Follow Back(TLFB)</measure>
    <time_frame>3 months</time_frame>
    <description>Pre-post change of self-reported days with khat use</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hopkins Symptom Checklist (HSCL)</measure>
    <time_frame>3 months</time_frame>
    <description>Pre-post change of self-reported depressive symptoms</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Posttraumatic Stress Disorder</condition>
  <condition>Khat Use Disorder</condition>
  <arm_group>
    <arm_group_label>Integrated Psychotherapeutic Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Integrated treatment of khat use disorder and PTSD</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Integrated Psychotherapeutic Intervention</intervention_name>
    <description>Evidence-based standard tools for the treatment of PTSD and comorbid khat dependence: Community Reinforcement Approach, Relapse Prevention, Narrative Exposure Therapy</description>
    <arm_group_label>Integrated Psychotherapeutic Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        PTSD (DSM-IV) Khat Dependence (DSM-IV)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Severe Psychotic Disorder Suicidality Mental Disability&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Africa Mental Health Foundation</name>
      <address>
        <city>Nairobi</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>May 10, 2017</last_update_submitted>
  <last_update_submitted_qc>May 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Konstanz</investigator_affiliation>
    <investigator_full_name>Michael Odenwald</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychotropic Drugs</mesh_term>
  </intervention_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/NCT02259530
org study id: 01DG13020_a
nct id: NCT02259530
lead sponsor: 
collaborator: 
has dmc: No
The research project will offer psychotherapeutic treatment to Somali refugees with PTSD and
      comorbid khat dependence. In this case series, evidence-based techniques will be applied and
      adapted to the cultural background of Somali refugees in Kenya.
More than 500.000 Somali refugees live in Kenya. This group is especially burdened by high
      rates of exposure to traumatic events, high prevalence of PTSD and a high comorbidity with
      substance use disorders, mainly related to khat (catha edulis). There's a shortage of
      literature on psychotherapeutic methods that are applicable in this group. The aim of this
      case series is to develop modifications of standard therapeutic techniques to the Somali
      culture and to the needs of this group. Twenty successive cases will be recruited from a
      community clinic where refugees often seek for treatment because of psychiatric problems.
      Senior level psychotherapists will apply and adapt techniques and approaches like Community
      Reinforcement Approach (CRA), Relapse Prevention (RP), and Narrative Exposure Therapy (NET);
      all sessions will be video recorded. Regular supervision with external experts and group
      discussions will be held to evaluate and adapt the single procedures and techniques. The aim
      of this study is the development of a standardized approach that can be used in a Randomized
      Controlled Trial which will be conduced in the future.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Posttraumatic Stress Diagnostic Scale (PDS)
time frame: 3 months
description: Pre-post change of self-reported PTSD-symptom severity
measure: Time-Line Follow Back(TLFB)
time frame: 3 months
description: Pre-post change of self-reported days with khat use
measure: Hopkins Symptom Checklist (HSCL)
time frame: 3 months
description: Pre-post change of self-reported depressive symptoms
arm group label: Integrated Psychotherapeutic Intervention
arm group type: Experimental
description: Integrated treatment of khat use disorder and PTSD
intervention type: Behavioral
intervention name: Integrated Psychotherapeutic Intervention
description: Evidence-based standard tools for the treatment of PTSD and comorbid khat dependence: Community Reinforcement Approach, Relapse Prevention, Narrative Exposure Therapy
arm group label: Integrated Psychotherapeutic Intervention
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Kenya
responsible party type: Principal Investigator
investigator affiliation: University of Konstanz
investigator full name: Michael Odenwald
investigator title: Researcher
mesh term: Stress Disorders, Post-Traumatic
mesh term: Psychotropic Drugs