<?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>IRCT20171225038062N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-13</date_registration>
      <primary_sponsor>Faculty of Psychology &amp; Educational sciences Mahdishahr</primary_sponsor>
      <public_title>The Effectiveness of Two Models Emotion Regulation Skills Training in Adolescents with Borderline Personality Disorder</public_title>
      <acronym>BPD</acronym>
      <scientific_title>Compare the Effectiveness of Emotion Regulation Skills Training based on Gross Model and  Linehan Model on Emotion Regulation Strategies, Emotional Cascade and Suicidal Toughts in Adolescents with Borderline Personality Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28438</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study has been used Random allocation rule. 45 adolescents who referred to counseling and psychology centers, psychiatric services as well as suicide emergency centers in Tehran were randomly entered to experimental and control groups using a draw container, Blinding description: In this study, participants who were adolescents with borderline personality disorder did not know about the allocation of study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Borderline Personality Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Includes experimental group ( 15 in the emotion regulation skills training based on  Linehan model). For the purposes of research before the intervention begins, the subjects were given Cognitive Emotion Regulation Questionnaire, Beck Scale for Suicide Ideation, Distress Tolerance Scale, Thought Suppression Questionnaire a questionnaire. After the end of the intervention, the questionnaires were again given to the participants. Intervention 2: Intervention group 2:  Includes experimental group ( 15 in the emotion regulation skills training based on  Gross model). For the purposes of research before the intervention begins, the subjects were given Cognitive Emotion Regulation Questionnaire, Beck Scale for Suicide Ideation, Distress Tolerance Scale, Thought Suppression Questionnaire a questionnaire. After the end of the intervention, the questionnaires were again given to the participants. Intervention 3: Control group: The control group received no intervention.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Information on the main outcomes of the study is available for sharing.

When:
6 months after printing results

To whom:
Mental health therapists

Conditions:
Psychologists

Where to obtain:
Seyede Samera Hoseini Omam

How to obtain:
A clear explanation of why the documentation is needed. Because the principle of confidentiality is very important in cases of suicide, therefore, caution will be given in certain circumstances.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahmood Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Psychology &amp; Educational sciences Mahdishahr , Semnan University , Darband, Mehdishahr, Semnan, Iran.</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3564111156</zip>
        <telephone>+98 23 3362 3300</telephone>
        <email>m_najafi@semnan.ac.ir</email>
        <affiliation>Faculty of Psychology &amp; Educational sciences Mahdishahr</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyede Samera Hoseini Omam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 18, Hoghoghi Ave., Shariati Ave., Enghelab Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1611994111</zip>
        <telephone>+98 21 7763 9333</telephone>
        <email>samera.hoseini@semnan.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Minimum First Level Education
Lack of comorbid mood disorders (bipolar, major depression)
Having at least one history of suicide attempt
With clinical symptoms of borderline personality disorder
It's been a year since the disorder diagnosis</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>19 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Substance abuse
Psychotic disorders
Under other psychological treatments
Under medication</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F60.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>اختلال شخصیت ناپایدار هیجانی</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Includes experimental group ( 15 in the emotion regulation skills training based on  Linehan model). For the purposes of research before the intervention begins, the subjects were given Cognitive Emotion Regulation Questionnaire, Beck Scale for Suicide Ideation, Distress Tolerance Scale, Thought Suppression Questionnaire a questionnaire. After the end of the intervention, the questionnaires were again given to the participants.</i_keyword>
      <i_keyword>Intervention group 2:  Includes experimental group ( 15 in the emotion regulation skills training based on  Gross model). For the purposes of research before the intervention begins, the subjects were given Cognitive Emotion Regulation Questionnaire, Beck Scale for Suicide Ideation, Distress Tolerance Scale, Thought Suppression Questionnaire a questionnaire. After the end of the intervention, the questionnaires were again given to the participants.</i_keyword>
      <i_keyword>Control group: The control group received no intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of Emotion regulation strategies in Cognitive Emotion Regulation Questionnaire (CERQ). Timepoint: Before the intervention begins and after the end of the intervention. Method of measurement: Cognitive Emotion Regulation Questionnaire (CERQ).</prim_outcome>
      <prim_outcome>Score of Emotional Cascade in Distress Tolerance Scale and Thought Suppression Questionnaire. Timepoint: Before the intervention begins and after the end of the intervention. Method of measurement: Distress Tolerance Scale and Thought Suppression Questionnaire.</prim_outcome>
      <prim_outcome>Score of suicidal thoughts in Beck Scale for Suicide Ideation. Timepoint: Before the intervention begins and after the end of the intervention. Method of measurement: Beck Scale for Suicide Ideation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Faculty of Psychology &amp; Educational sciences Mahdishahr</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-12</approval_date>
        <contact_name>Ethics committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Semnan University of Medical Sciences and Health Services, Basij Boulevard, Semnan Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
