<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/NCT01731418</url>
  </required_header>
  <id_info>
    <org_study_id>TO-10122012-UK</org_study_id>
    <nct_id>NCT01731418</nct_id>
  </id_info>
  <brief_title>NET in Iranian Women Suffering From Post Traumatic Stress Symptoms</brief_title>
  <official_title>Efficacy of Narrative Exposure Therapy (NET) in a Sample of Iranian Women Exposed to Intimate Partner Violence (IPV)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Konstanz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tehran University of Medical Sciences</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>
      The proposed study seeks to investigate to what extent Narrative Exposure Therapy (NET) is an&#xD;
      effective treatment for the reduction of symptoms of Post-Traumatic Stress Disorder (PTSD)&#xD;
      and depression and for the improvement of daily functioning in Iranian women who have&#xD;
      experienced intimate partner violence (IPV). In addition, the study seeks to investigate&#xD;
      whether NET therapy could lead to the reduction of Intimate Partner Violence (IPV) within&#xD;
      their marriage.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Posttraumatic Diagnostic Scale (PDS/PSS-I).</measure>
    <time_frame>Symptoms will be assessed at pre-treatment-point and post-treatment-point (up to 6-month follow-ups)</time_frame>
    <description>The PDS/PSS-I is a 17-item screening instrument on a 4-point-Likert-scale (0 = not at all to 3 = very much). The PDS aims at assessing all Diagnostic and Statistical Manual (DSM-IV) criteria of a Post Traumatic Stress Disorder (PTSD), and thus it includes information about the nature of the traumatic event and the level of functional interference.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups</time_frame>
    <description>The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Hopkins Symptom Checklist-25 (HSCL-25)</measure>
    <time_frame>At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups</time_frame>
    <description>The Hopkins Symptom Checklist 25 would be used to screen for symptoms of depression and anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived Stress Scale-4</measure>
    <time_frame>At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups</time_frame>
    <description>The Perceived Stress Scale (PSS) would be used to assess the perception of stress over the course of the last month preceding the interview</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite Abuse Scale (CAS)</measure>
    <time_frame>At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups</time_frame>
    <description>The CAS, a 30-item validated research instrument, is a widely used self-report questionnaire of behaviors that women describe as abusive by their partners. It is a self-report measure that provides standardized sub scale scores on four dimensions of intimate partner abuse. The four dimensions are Severe Combined Abuse, Emotional Abuse, Physical Abuse, and Harassment, scaled from 0 (never) to 5 (daily) over a period of 12-month.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Work and Social Adjustment Scale (WSAS)</measure>
    <time_frame>At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups</time_frame>
    <description>The WSAS is a widely used 5-item measure of disability. Its psychometric properties were analyzed and shown in different studies and disorders (Mataix-Cols et al, 2005; Mundt et al, 2002).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Life Events Checklist</measure>
    <time_frame>At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups</time_frame>
    <description>The Life Events Checklist (LEC) is a brief, 17-item, self-report measure designed to screen for potentially traumatic events in a respondent's lifetime. The LEC assesses exposure to 16 events known to potentially result in PTSD or distress and includes one item assessing any other extraordinarily stressful event not captured in the first 16 items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Checklist of family violence</measure>
    <time_frame>At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups</time_frame>
    <description>This checklist assessing the incidence of domestic violence was developed by Catani (2002) and includes questions on physical abuse, verbal violence, neglect and sexual abuse as well as witnessing intimate partner violence between parents.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Borderline Symptom List (BSL-23)</measure>
    <time_frame>At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups</time_frame>
    <description>The BSL-23 is a shortened form of the full version of the BSL-95. The self-report questionnaire assesses borderline-specific symptomatology on a five response scale ranging from 0 (not at all) to 4 (very strongly).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Mental Disorders</condition>
  <condition>Domestic Violence</condition>
  <arm_group>
    <arm_group_label>Treamtent-as-usual</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment-as-usual can be defined as the commonly used psychotherapy for abused women in Iran, such as medical therapy and/or supportive psychotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Narrative Exposure Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Narrative Exposure Therapy (NET) is a standardized short-term approach based on the principles of cognitive behavioral exposure therapy and testimony therapy for the treatment of PTSD resulting from organized violence.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Narrative Exposure Therapy</intervention_name>
    <description>Narrative Exposure Therapy (NET) is a treatment approach that was developed by a research group of the University of Konstanz (Schauer, Neuner, &amp; Elbert, 2005, 2011). In NET, the patient repeatedly talks about the most arousing traumatic events in detail while re-experiencing the emotions associated with this event. In the process, the patient constructs a narration of his life, focusing on the detailed report of the traumatic experiences.</description>
    <arm_group_label>Narrative Exposure Therapy</arm_group_label>
    <other_name>NET</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment-as-usual</intervention_name>
    <description>Treatment-as-usual was defined as the commonly used psychotherapy for abused women in Iran, such as medical therapy and/or supportive counseling.&#xD;
Regarding supportive counselling, the sessions included:&#xD;
Life skill education CBT techniques ACT techniques Finding resources to stop violence Discussing marital and sexual conflicts with the presence of husbands Working on their children problems Improvement of communication skills</description>
    <arm_group_label>Treamtent-as-usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being victims of Intimate Partner Violence and seeking help at target clinics in order&#xD;
             to reduce their psychological symptoms, currently living together with their&#xD;
             partner/husband, meeting the set cut-off point on the PTSD scale according to DSM-IV.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  schizophrenia, epilepsy, mental retardation, drug abuse and mal-nourishment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Elbert, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>University of Konstanz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mental Health Clinics</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>April 24, 2017</last_update_submitted>
  <last_update_submitted_qc>April 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Konstanz</investigator_affiliation>
    <investigator_full_name>Tahere Orang</investigator_full_name>
    <investigator_title>PhD Student</investigator_title>
  </responsible_party>
  <keyword>Post Traumatic Stress Disorder</keyword>
  <keyword>Depression</keyword>
  <keyword>Intimate Partner violence</keyword>
  <keyword>Narrative Exposure Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</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/NCT01731418
org study id: TO-10122012-UK
nct id: NCT01731418
lead sponsor: 
collaborator: 
has dmc: Yes
The proposed study seeks to investigate to what extent Narrative Exposure Therapy (NET) is an
      effective treatment for the reduction of symptoms of Post-Traumatic Stress Disorder (PTSD)
      and depression and for the improvement of daily functioning in Iranian women who have
      experienced intimate partner violence (IPV). In addition, the study seeks to investigate
      whether NET therapy could lead to the reduction of Intimate Partner Violence (IPV) within
      their marriage.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Posttraumatic Diagnostic Scale (PDS/PSS-I).
time frame: Symptoms will be assessed at pre-treatment-point and post-treatment-point (up to 6-month follow-ups)
description: The PDS/PSS-I is a 17-item screening instrument on a 4-point-Likert-scale (0 = not at all to 3 = very much). The PDS aims at assessing all Diagnostic and Statistical Manual (DSM-IV) criteria of a Post Traumatic Stress Disorder (PTSD), and thus it includes information about the nature of the traumatic event and the level of functional interference.
measure: The Patient Health Questionnaire-9 (PHQ-9)
time frame: At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups
description: The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module
measure: The Hopkins Symptom Checklist-25 (HSCL-25)
time frame: At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups
description: The Hopkins Symptom Checklist 25 would be used to screen for symptoms of depression and anxiety.
measure: Perceived Stress Scale-4
time frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
description: The Perceived Stress Scale (PSS) would be used to assess the perception of stress over the course of the last month preceding the interview
measure: Composite Abuse Scale (CAS)
time frame: At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups
description: The CAS, a 30-item validated research instrument, is a widely used self-report questionnaire of behaviors that women describe as abusive by their partners. It is a self-report measure that provides standardized sub scale scores on four dimensions of intimate partner abuse. The four dimensions are Severe Combined Abuse, Emotional Abuse, Physical Abuse, and Harassment, scaled from 0 (never) to 5 (daily) over a period of 12-month.
measure: The Work and Social Adjustment Scale (WSAS)
time frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
description: The WSAS is a widely used 5-item measure of disability. Its psychometric properties were analyzed and shown in different studies and disorders (Mataix-Cols et al, 2005; Mundt et al, 2002).
measure: The Life Events Checklist
time frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
description: The Life Events Checklist (LEC) is a brief, 17-item, self-report measure designed to screen for potentially traumatic events in a respondent's lifetime. The LEC assesses exposure to 16 events known to potentially result in PTSD or distress and includes one item assessing any other extraordinarily stressful event not captured in the first 16 items.
measure: Checklist of family violence
time frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
description: This checklist assessing the incidence of domestic violence was developed by Catani (2002) and includes questions on physical abuse, verbal violence, neglect and sexual abuse as well as witnessing intimate partner violence between parents.
measure: Borderline Symptom List (BSL-23)
time frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
description: The BSL-23 is a shortened form of the full version of the BSL-95. The self-report questionnaire assesses borderline-specific symptomatology on a five response scale ranging from 0 (not at all) to 4 (very strongly).
arm group label: Treamtent-as-usual
arm group type: Other
description: Treatment-as-usual can be defined as the commonly used psychotherapy for abused women in Iran, such as medical therapy and/or supportive psychotherapy.
arm group label: Narrative Exposure Therapy
arm group type: Experimental
description: Narrative Exposure Therapy (NET) is a standardized short-term approach based on the principles of cognitive behavioral exposure therapy and testimony therapy for the treatment of PTSD resulting from organized violence.
intervention type: Behavioral
intervention name: Narrative Exposure Therapy
description: Narrative Exposure Therapy (NET) is a treatment approach that was developed by a research group of the University of Konstanz (Schauer, Neuner, & Elbert, 2005, 2011). In NET, the patient repeatedly talks about the most arousing traumatic events in detail while re-experiencing the emotions associated with this event. In the process, the patient constructs a narration of his life, focusing on the detailed report of the traumatic experiences.
arm group label: Narrative Exposure Therapy
other name: NET
intervention type: Other
intervention name: Treatment-as-usual
description: Treatment-as-usual was defined as the commonly used psychotherapy for abused women in Iran, such as medical therapy and/or supportive counseling.
Regarding supportive counselling, the sessions included:
Life skill education CBT techniques ACT techniques Finding resources to stop violence Discussing marital and sexual conflicts with the presence of husbands Working on their children problems Improvement of communication skills
arm group label: Treamtent-as-usual
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas Elbert, Professor
role: Study Chair
affiliation: University of Konstanz
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: University of Konstanz
investigator full name: Tahere Orang
investigator title: PhD Student
mesh term: Mental Disorders