<?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>IRCT20180516039680N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-27</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the effect of emotion regulation training on emotional and cognitive status of adolescent girls attempting suicide.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effect of emotion regulation training on emotional and cognitive status of adolescent girls attempting suicide referred to Ebne sina hospital in 2017-2018.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31415</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Blinding description: Data will be analyzed without expressing the type of group to the analyst.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Cognitive and emotional status. Condition 2: Depression. Condition 3: Anxiety. Condition 4: Stress. Condition 5: Impulsivity. Condition 6: Suicidal thought.</hc_freetext>
      <i_freetext>Intervention 1: intervention group: The intervention  group will receive 8 sessions of emotion regulation training (twice a week). And questionnaires will be filled by the group at the beginning of the study and one month later. Intervention 2: Control group:The control group will not receive interventionand and the questionnaires will be filled by the group at the beginning of the study and one month later. And In order to comply with ethical principles, the control group will be given education after the end of the study or instruction booklet.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is A clear explanation of why the documentation is needed. Because the principle of confidentiality is very important in cases of suicide, so it will be decided with caution and in special circumstances.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedyounes Hosseini sarani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor 2,  st10th golmorvarid Next to the left side,Baharstan Town.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7169654654</zip>
        <telephone>+98 71 3840 6737</telephone>
        <email>younes_smile@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyedyounes Hosseini Sarani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor 2,  st10th golmorvarid Next to the left side,Baharstan Town</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7169654654</zip>
        <telephone>+98 71 3840 6737</telephone>
        <email>hoseini_y@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Teenage girls aged 13 to 18 years 
Suicide attempt history
Willingness to participate in research</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>People attending other psychotherapy sessions simultaneously
Bipolar patients
Having symptoms of psychosis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group: The intervention  group will receive 8 sessions of emotion regulation training (twice a week). And questionnaires will be filled by the group at the beginning of the study and one month later.</i_keyword>
      <i_keyword>Control group:The control group will not receive interventionand and the questionnaires will be filled by the group at the beginning of the study and one month later. And In order to comply with ethical principles, the control group will be given education after the end of the study or instruction booklet.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive emotion regulation. The cognitive emotion regulation evaluates 9 strategy of self-denial, admission, rumination, positive re-focus, re-focus on planning, positive reappraisal, perceptiveness, disaster, and other people's health. Timepoint: At the beginning of the study and 1 month after the study. Method of measurement: Cognitive emotion regulation questionnaire (CERQ).</prim_outcome>
      <prim_outcome>Depression. The substage of depression, includes the expressions of unhappy mood, lack of self-esteem, despair, worthlessness of life, lack of interest in conflict, lack of enjoyment of life, and lack of energy and power. Timepoint: At the beginning of the study and 1 month after the study. Method of measurement: Depression anxiety and stress scale 21 qestionnaire.</prim_outcome>
      <prim_outcome>Anxiety. Anxiety subscale has phrases that attempt to assess physiological arousal, fears, and situational anxiety. Timepoint: At the beginning of the study and 1 month after the study. Method of measurement: Depression anxiety and stress Scale 21 questionnaire.</prim_outcome>
      <prim_outcome>Stress. Stress subscale includes phrases such as difficulty in achieving relaxation, nervous tension, irritability and restlessness. Timepoint: At the beginning of the study and 1 month after the study. Method of measurement: Depression anxiety and stress scale 21 questionnaire.</prim_outcome>
      <prim_outcome>Impulsivity. Measures three components of non-planning, motion impulse, and cognitive impulse. Timepoint: At the beginning of the study and 1 month after the study. Method of measurement: Barratt Impulsiveness Scale, eleventh edition.</prim_outcome>
      <prim_outcome>Suicidal thoughts. Detecting and measuring the severity of attitudes and planning to commit suicide. Timepoint: At the beginning of the study and 1 month after the study. Method of measurement: Beck suicide scal idetion questionnaire.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-10</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences.</contact_name>
        <contact_address>Central building of 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>
