<?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>IRCT20230221057474N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-23</date_registration>
      <primary_sponsor>Toxicological Research Center</primary_sponsor>
      <public_title>The effect of spiritual intelligence in preventing suicide attempt</public_title>
      <acronym></acronym>
      <scientific_title>The effect of spiritual intelligence based on heart intelligence training on the well-being of people who attempted suicide.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68729</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: A table of random numbers will be used. Random number tables are generated by computers that randomly set the numbers. First, a two-digit code (according to the number of volunteers, which is 60) is given to each candidate , and after creating the table, a random selection of numbers is made. To select sample people from the table, randomly start from a point in the table moving in the direction of the row or column. The selection of the point can be done by closing the eyes and placing a finger or the tip of a pen on the table. Moving in the direction of the row or column does not make any difference and this is optional. After this, the path numbers are controlled, which will be dealt with two types of numbers, one of which is smaller than the volume of the population of the study and the other is larger than the number of the population. Only smaller numbers should be considered and selected. The selected number is actually the individual code that is selected as the sample. This should be continued until enough small number can be selected based on the number of volunteers. The first 30 numbers are patients who assigned to the control group and the second 30 numbers are patients who assigned to the intervention group.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Suicide.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to receiving routine psychiatric counseling in the hospital, the patients of this group will also be trained in spiritual intelligence based on heart intelligence. Intervention 2: Control group: Patients in this group will only undergo routine psychiatric consultation at the hospital before discharge.</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:
Only a part of the data, such as the information related to the main result can be shared.

When:
The access period starts after the publication of the last results

To whom:
University researchers

Conditions:
The only criterion will be citing the name of principal investigators in resultant academic works

Where to obtain:
By contacting principal investigators via this email: dr.talaie@gmail.com

How to obtain:
Sending the email by the requester including their academic position or business information

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Haleh Talaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Toxicological Research Center, Loghman Hakim Hospital, Kamali Avenue, South Karegar Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13336311510</zip>
        <telephone>+98 21 5541 8175</telephone>
        <email>dr.talaie@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Haleh Talaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Toxicological Research Center, Loghman Hakim Hospital, Kamali Avenue, South Karegar Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13336311510</zip>
        <telephone>+98 21 5541 8175</telephone>
        <email>dr.talaie@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A history of suicide attempts
The patient's consent to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to participate in three consecutive training sessions
Unwillingness to continue participating in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T14.91</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Suicide attempt</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: In addition to receiving routine psychiatric counseling in the hospital, the patients of this group will also be trained in spiritual intelligence based on heart intelligence.</i_keyword>
      <i_keyword>Control group: Patients in this group will only undergo routine psychiatric consultation at the hospital before discharge.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The mental health status of patients before and after the intervention according to the standard questionnaires. Timepoint: The mental health status of the patients will be checked at the beginning of the study and after the completion of the training course (two-month period). Method of measurement: Ryff scales of psychological well-being, King’s Spiritual Intelligence Scale (SISRI), Beck Scale for Suicidal Ideation (BSSI).</prim_outcome>
      <prim_outcome>Suicide re-attempts during the 6-month period of follow-up. Timepoint: Re-attempting suicide will be investigated during the six-month follow-up period after the completion of the training course. Method of measurement: Observation and contact with patients and family member.</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>Toxicological Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-20</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Science</contact_name>
        <contact_address>7th Floor, Building Number 2, Shahid Beheshti University of Medical Science , Arabi Avenue, Daneshjoo Boulevard, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
