<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2013050313211N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-05-29</date_registration>
      <primary_sponsor>Mental Health Research Network</primary_sponsor>
      <public_title>The treatment of mental disorders in women exposed to domestic violence</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of Narrative Exposure Therapy (NET) in a Sample of Iranian Women Exposed to Intimate Partner Violence (IPV) &#13;
-A randomized trial-</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-05-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13149</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Post-Traumatic Stress Disorder. Condition 2: Depression.</hc_freetext>
      <i_freetext>Intervention 1: Narrative Exposure Therapy (NET). NET is a treatment approach that was developed for the treatment of PTSD resulting from organized violence. NET was developed by a research group of the University of Konstanz (Schauer, Neuner, &amp; Elbert, 2005, 2011) as a standardized short-term approach based on the principles of cognitive behavioral exposure therapy and testimony therapy by adapting it to meet the needs of traumatized survivors of war and torture. 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. The majority of people habituates and loses the emotional response to the traumatic memory, which consequently leads to a remission of PTSD symptoms. Also, by using NET we are able to carefully step forward through the complete biography of our patients’ lives in chronological order. In telling the story, the patient is exposed to the sensory information that accompanies the memory and to the image of the events themselves. The patient actually triggers his or her own fear network in the telling by narrating the fragments throughout the course of therapy and he or she is able to reweave the events back into a cool-system framework controlling the triggers present with the hot memories. As a result, the accompanying anxiety, which evolved from the strangeness of dissociative fragments, is defused. All somatosensory percepts (physical sensations), cognitions (thoughts), and emotions relevant to the fear network and involved in the traumatic sequences of memory will be comprehensively uncovered in detail as the narrative unfolds. The course of events is established (in time and place), labeled and transferred into speech until a meaningful and consistent narrative is reached. All traumatic events are revisited until their horrifying impact dissolves. In other words, NET focuses on both the habituation of emotional responses to the memories of the traumatic events and on the construction of a detailed narrative of the events and their consequences. A general guideline for the organization of sessions can be outlined as follows; Session 1: Diagnosis and psycho-education. Session 2: lifeline exercise beginning with the birth and ending with the future in order to define and locate traumatic and non-traumatic events. Session 3: Exposure to most pressing traumatic event. Subsequent sessions: (Re) reading of the narrative collected in previous sessions and continuing the narration/exposure of subsequent traumatic life events. Final session: Rereading and handing-over of the complete narration. The women in the NET group will go to the clinic once a week, and will have total of 6-8 these sessions. In addition, in accordance with the NET manual, at the end of each session, a written account of what is told throughout the session is composed by the therapist, which will be read to the client at the beginning of the next session for her approval of the content of the account. Upon completion of the treatment, a brief biography of the client and her traumatic and non-traumatic experiences which she has told will be given to her. Intervention 2: Treatment-as-usual. Treatment-as-usual can be defined as the commonly used psychotherapy for abused women in Iran, such as medical therapy and/or supportive psychotherapy. After participants are randomly allocated to the treatment-as-usual group, the researcher will ask the therapists of this group to write a summary report of the treatment procedure after each session and submit it to the researcher. Thus, the researcher will be supervising the procedures of the treatment-as-usual sessions and will record the treatment procedure.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahere Orang</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koohsar ST, Sardar ST, Sardar Alley, Number 5</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 4430 7915</telephone>
        <email>minaorang@gmail.com</email>
        <affiliation>Mental Health Research Network</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahere Orang</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koohsar ST, Sardar ST, Sardar Alley, Number 5</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 4430 7915</telephone>
        <email>minaorang@gmail.com</email>
        <affiliation>Mental Health Research Network</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Within this treatment study women being victims of Intimate Partner Violence and seeking help at target clinics in order to reduce their psychological symptoms, should be invited to take part in the proposed study. Only women currently living together with their partner/husband and aged between 16 and 60 years will be included. Also, the women taking part in the study should meet the set cut-off point on the PTSD scale according to DSM-IV.  Women, suffering from schizophrenia, epilepsy, mental retardation, drug abuse and mal-nourishment will be excluded.</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Narrative Exposure Therapy (NET). NET is a treatment approach that was developed for the treatment of PTSD resulting from organized violence. NET was developed by a research group of the University of Konstanz (Schauer, Neuner, &amp; Elbert, 2005, 2011) as a standardized short-term approach based on the principles of cognitive behavioral exposure therapy and testimony therapy by adapting it to meet the needs of traumatized survivors of war and torture. 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. The majority of people habituates and loses the emotional response to the traumatic memory, which consequently leads to a remission of PTSD symptoms. Also, by using NET we are able to carefully step forward through the complete biography of our patients’ lives in chronological order. In telling the story, the patient is exposed to the sensory information that accompanies the memory and to the image of the events themselves. The patient actually triggers his or her own fear network in the telling by narrating the fragments throughout the course of therapy and he or she is able to reweave the events back into a cool-system framework controlling the triggers present with the hot memories. As a result, the accompanying anxiety, which evolved from the strangeness of dissociative fragments, is defused. All somatosensory percepts (physical sensations), cognitions (thoughts), and emotions relevant to the fear network and involved in the traumatic sequences of memory will be comprehensively uncovered in detail as the narrative unfolds. The course of events is established (in time and place), labeled and transferred into speech until a meaningful and consistent narrative is reached. All traumatic events are revisited until their horrifying impact dissolves. In other words, NET focuses on both the habituation of emotional responses to the memories of the traumatic events and on the construction of a detailed narrative of the events and their consequences. A general guideline for the organization of sessions can be outlined as follows; Session 1: Diagnosis and psycho-education. Session 2: lifeline exercise beginning with the birth and ending with the future in order to define and locate traumatic and non-traumatic events. Session 3: Exposure to most pressing traumatic event. Subsequent sessions: (Re) reading of the narrative collected in previous sessions and continuing the narration/exposure of subsequent traumatic life events. Final session: Rereading and handing-over of the complete narration. The women in the NET group will go to the clinic once a week, and will have total of 6-8 these sessions. In addition, in accordance with the NET manual, at the end of each session, a written account of what is told throughout the session is composed by the therapist, which will be read to the client at the beginning of the next session for her approval of the content of the account. Upon completion of the treatment, a brief biography of the client and her traumatic and non-traumatic experiences which she has told will be given to her.</i_keyword>
      <i_keyword>Treatment-as-usual. Treatment-as-usual can be defined as the commonly used psychotherapy for abused women in Iran, such as medical therapy and/or supportive psychotherapy. After participants are randomly allocated to the treatment-as-usual group, the researcher will ask the therapists of this group to write a summary report of the treatment procedure after each session and submit it to the researcher. Thus, the researcher will be supervising the procedures of the treatment-as-usual sessions and will record the treatment procedure.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post-Traumatic Stress Disorder. Timepoint: Pre- and Post Treatment, 3 and 6 follow-ups. Method of measurement: The interview format of Posttraumatic Diagnostic Scale (PSS-I).</prim_outcome>
      <prim_outcome>Depression. Timepoint: Pre- and Post Treatment, 3 and 6 follow-ups. Method of measurement: The Patient Health Questionnaire (PHQ-9).</prim_outcome>
      <prim_outcome>Depression and Anxiety. Timepoint: Pre- and Post Treatment, 3 and 6 follow-ups. Method of measurement: The Hopkins Symptom Checklist 25.</prim_outcome>
      <prim_outcome>The perception of stress. Timepoint: Pre- and Post Treatment, 3- and 6-month follow-ups. Method of measurement: Perceived Stress Scale-10.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Intimate Partner Violence. Timepoint: Pre- and post treatment, 3- and 6-month follow-ups. Method of measurement: Composite Abuse Scale (CAS).</sec_outcome>
      <sec_outcome>The Work and Social Adjustment. Timepoint: Pre- and post treatment, 3- and 6-month follow-ups. Method of measurement: The Work and Social Adjustment Scale.</sec_outcome>
      <sec_outcome>Borderline Symptoms. Timepoint: Pre- and post treatment, 3- and 6-month follow-ups. Method of measurement: Borderline Symptom List (BSL-23).</sec_outcome>
      <sec_outcome>The Life Events Checklist. Timepoint: Pre- and post treatment, 3- and 6-month follow-ups. Method of measurement: The Life Events Checklist.</sec_outcome>
      <sec_outcome>Domestic violence in client's family. Timepoint: Pre-treatment. Method of measurement: Modified Adverse Childhood Experiences (short MACE-I).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Tahere Orang</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>TO-10122012-UK</sec_id>
        <issuing_authority>ClinicalTrials</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Mental Health Research Network</source_name>
      <source_name>Tahere Orang</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-03-12</approval_date>
        <contact_name>Mental Health Research Network, Tehran Psychiatric Institute</contact_name>
        <contact_address>Sattar khan ST, Niyayesh ST, Mansouri alley, Tehran Psychiatric Institute Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
