<?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>IRCT20190417043303N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-08</date_registration>
      <primary_sponsor>Shiraz University</primary_sponsor>
      <public_title>Group therapy based on mentalization and dialectical behavior in patients with borderline personality disorder</public_title>
      <acronym></acronym>
      <scientific_title>Group therapy based on mentalization and dialectical behavior on attachment styles, mentalization, social cognition, and clinical symptoms in patients with borderline personality disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39064</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: To perform the division (conventionally) the intervention groups and control group were named A, B and C. Then, 60 numbers of the random numbers table were selected by computer; if the first number was between 1 to 3 it was identified as A (MBT intervention group), first numbers from 4 to 6 were identified as B (DBT intervention group), and first numbers from 7 to 9 were identified as C (control group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>borderline personality disorder.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: group therapy based on mentalization: The aim of  treatment based on mentalization is to establish balance in problems of patients with borderline personality disorder by enhancing the ability to be aware of mental status under anxiety conditions and to activ their secure attachment style. Interventions lasted 10 weeks. sessions were held twice a week and every session last two hours. Sessions contain: Concept of mentalization, The concept of problems with mentalizing, Why do we have emotions and what are the basic types?, How do we register and regulate emotions? Relationship between mentalising and emotions., The significance of attachment relationships?, Relationship between attachment and mentalization, The concept of personality disorder and borderline personality disorder, Mentalization-based treatment. Relationship among Anxiety, attachment and mentalizing, Relationship among Depression, attachment and mentalizing. Intervention 2: Second intervention group: group therapy based on dialectical behavior: This treatment was developed to work with patients with borderline personality who had a history of suicide and not improved by conventional cognitive behavioral therapy. This treatment is based on the acquisition of skills and behavioral shaping. Interventions lasted 10 weeks. sessions were held twice a week and every session last two hours. Session contain some skills in domain mindfulness, emotion regulation, distress tolerance and relationship effectiveness. Mindfulness skills such as: training state of mind, paying attention to what the world, body and mind is doing, paying all of your attention to one thing at a time. Distress tolerance skills such as: explain about distress tolerance goals, use of distracting, calming yourself and thinking about your choices for surviving bad times, use of breathing, smiling and focusing in accepting reality. Emotion regulation skills such as: explain about emotion regulation, identifying emotions, benefit of emotions, keeping control of your emotions, change how you feel by acting differently. Relationship effectiveness skills such as: explain about goals of relationship effectiveness, the reason of use relationship effectiveness skills, keeping good relationships. Intervention 3: Control group: no psychological intervention: Subjects in this group did not receive psychological interventions individually or in groups.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Khabir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dept. of Clinical Psychology, Faculty of Education and Psychology, Shiraz University</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71964-84334</zip>
        <telephone>+98 71 3822 9388</telephone>
        <email>leilakhabir@gmail.com</email>
        <affiliation>Shiraz University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Khabir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Education and Psychology, Shiraz University, Eram Square</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۱۹۶۴-۸۴۳۳۴</zip>
        <telephone>+98 6134653</telephone>
        <email>l.khabir@shirazu.ac.ir</email>
        <affiliation>Shiraz University</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>age range 18 to 25
having at least primary school education
having received diagnosis of borderline personality disorder based on DSM5
get diagnosis of borderline personality disorder as a primary diagnosis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>substance dependency (but not substance abuse)
psychiatric admission during treatment
receive any other psychotherapy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F60.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Borderline personality disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: group therapy based on mentalization: The aim of  treatment based on mentalization is to establish balance in problems of patients with borderline personality disorder by enhancing the ability to be aware of mental status under anxiety conditions and to activ their secure attachment style. Interventions lasted 10 weeks. sessions were held twice a week and every session last two hours. Sessions contain: Concept of mentalization, The concept of problems with mentalizing, Why do we have emotions and what are the basic types?, How do we register and regulate emotions? Relationship between mentalising and emotions., The significance of attachment relationships?, Relationship between attachment and mentalization, The concept of personality disorder and borderline personality disorder, Mentalization-based treatment. Relationship among Anxiety, attachment and mentalizing, Relationship among Depression, attachment and mentalizing.</i_keyword>
      <i_keyword>Second intervention group: group therapy based on dialectical behavior: This treatment was developed to work with patients with borderline personality who had a history of suicide and not improved by conventional cognitive behavioral therapy. This treatment is based on the acquisition of skills and behavioral shaping. Interventions lasted 10 weeks. sessions were held twice a week and every session last two hours. Session contain some skills in domain mindfulness, emotion regulation, distress tolerance and relationship effectiveness. Mindfulness skills such as: training state of mind, paying attention to what the world, body and mind is doing, paying all of your attention to one thing at a time. Distress tolerance skills such as: explain about distress tolerance goals, use of distracting, calming yourself and thinking about your choices for surviving bad times, use of breathing, smiling and focusing in accepting reality. Emotion regulation skills such as: explain about emotion regulation, identifying emotions, benefit of emotions, keeping control of your emotions, change how you feel by acting differently. Relationship effectiveness skills such as: explain about goals of relationship effectiveness, the reason of use relationship effectiveness skills, keeping good relationships.</i_keyword>
      <i_keyword>Control group: no psychological intervention: Subjects in this group did not receive psychological interventions individually or in groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Borderline personality disorder severity. Timepoint: before, immediately and two month after the intervention. Method of measurement: borderline personality disorder severity index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Attachment styles. Timepoint: before, immediately and two month after the intervention. Method of measurement: Revised Adult Attachment Scale.</sec_outcome>
      <sec_outcome>Mentalization. Timepoint: before, immediately and two month after the intervention. Method of measurement: Reflective Functioning Questionnaire.</sec_outcome>
      <sec_outcome>Social cognition. Timepoint: before, immediately and two month after the intervention. Method of measurement: ‘Reading the Mind in the Eyes’’ Test Revised Version.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shiraz University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-20</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
