<?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>IRCT20131130015589N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-01</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The efficiency of emotion regulation on Gross model on Illogical Believes on Patient at risk of suicide</public_title>
      <acronym></acronym>
      <scientific_title>The efficiency of emotion regulation on Gross model on Illogical Believes on Patient at risk of suicide: Clinical trial with control group</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70969</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The current research will be conducted as a single-blind clinical trial, and the sample members will be 30 patients who, based on screening, had a high score on the suicidal ideation scale upon entering Ibn Sina Hospital in Shiraz. Each participant is given a unique code. People who have an even code are classified in the control group (15 people) and people who have an odd code are classified in the experimental group (15 people).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Emotion regulation. Condition 2: Gross model. Condition 3: Illogical Believes. Condition 4: Risk of suicide.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 15 of the patients who, based on the screening, had a high score on the scale of suicidal thoughts upon entering the Ibn Sina Hospital in Shiraz, and were assigned an individual code in the classification, are included in this group (the examiner has no role in their classification). First, an explanatory meeting is held for sample people. Then, for this group, eight group therapy sessions of Grass's emotion regulation model with specific topics will be provided for two hours and within a month. For each session, a task is determined that is close to the topic. The topics of the sessions include: 1) introduction, 2) selection of the situation, 3) selection of the situation, 4) modification of the situation, 5) expansion of attention, 6) cognitive evaluation, 7 ) response adjustment and 8) application evaluation. Intervention 2: Control group: 15 patients who, based on the screening, had a high score on the suicidal ideation scale upon entering the Ibn Sina Hospital in Shiraz, and received an even code in the division, are included in this group (the examiner has no role in their division).This group receives education related to public health.</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 I have not decided yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arash Mani Kazeron</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hafez Medical Education Hospital, Chamran Blvd., Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7199896376</zip>
        <telephone>+98 71 3627 9319</telephone>
        <email>mania@sums.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arash Mani Kazeron</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hafez Educational Hospital, Shahid Chamran Boulevard, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7199896376</zip>
        <telephone>+98 71 3627 9319</telephone>
        <email>mania@sums.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have a high score on the suicide scale.
Have a stable mood.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_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>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 15 of the patients who, based on the screening, had a high score on the scale of suicidal thoughts upon entering the Ibn Sina Hospital in Shiraz, and were assigned an individual code in the classification, are included in this group (the examiner has no role in their classification). First, an explanatory meeting is held for sample people. Then, for this group, eight group therapy sessions of Grass's emotion regulation model with specific topics will be provided for two hours and within a month. For each session, a task is determined that is close to the topic. The topics of the sessions include: 1) introduction, 2) selection of the situation, 3) selection of the situation, 4) modification of the situation, 5) expansion of attention, 6) cognitive evaluation, 7 ) response adjustment and 8) application evaluation.</i_keyword>
      <i_keyword>Control group: 15 patients who, based on the screening, had a high score on the suicidal ideation scale upon entering the Ibn Sina Hospital in Shiraz, and received an even code in the division, are included in this group (the examiner has no role in their division).This group receives education related to public health.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Up-regulation (proper regulation) or down-regulation of positive or negative emotions. Also emotional re-evaluation and emotional suppression of the studied subjects. Timepoint: Before the intervention, After the intervention and one month after the intervention. Method of measurement: Emotional Regulation Questionnaire (EPQ) Gross and John (2003).</prim_outcome>
      <prim_outcome>Irrational beliefs of the studied people such as: helplessness against change, expecting approval from others, avoiding problems and emotional irresponsibility. Timepoint: Before the intervention, After the intervention and one month after the intervention. Method of measurement: Standard questionnaire of irrational beliefs Jones (1969) version 40 questions.</prim_outcome>
      <prim_outcome>The severity of suicidal thoughts in the studied subjects. Timepoint: Before the intervention, After the intervention and one month after the intervention. Method of measurement: Beck Suicidal Ideation Scale (BSS).</prim_outcome>
      <prim_outcome>Measuring the intensity of negative attitude, pessimism and hopelessness towards the future. Timepoint: Before the intervention, After the intervention and one month after the intervention. Method of measurement: Beck Hopelessness Scale (BHS).</prim_outcome>
      <prim_outcome>Evaluation of three cognitive dimensions of attitude in the studied subjects based on attitude towards self, attitude towards the world, attitude towards the future. Timepoint: Before the intervention, After the intervention and one month after the intervention. Method of measurement: Beckham et al. Cognitive Triad Inventory (CTI).</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>Islamic Azad University, Shiraz branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-19</approval_date>
        <contact_name>Research Ethics Committee of Islamic Azad University, Shiraz Branch</contact_name>
        <contact_address>Islamic Azad University Pardis, km 5 Sadra City road, Shiraz Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
