<?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>IRCT20180416039321N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-23</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of the Logotherapy based program on motivations for suicide attempts and distress tolerance</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of the Logotherapy based program on motivations for suicide attempts and distress tolerance in suicidal patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69104</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 70 patients who meet the conditions for entering the study will be selected, then they will be randomly assigned into two groups of 35 people, intervention and control. Random allocation of samples in two intervention and control groups is done using a table of random numbers. A table of random numbers is a collection of numbers that are generated completely randomly without a specific pattern or order and are made into a table.To use the table of random numbers, the researcher first determines the direction of reading the numbers in the table (for example, up, down, left or right). Also, numbers are considered for the studied groups (for example, even numbers are considered for the intervention group and odd numbers are considered for the control group). For this purpose, the researcher selects one of the digits of the random number table with his eyes closed, Then, by moving in one of the predetermined directions in the table of random numbers, chooses 35 even numbers and 35 odd numbers and writes them down on paper. All selected numbers are placed in a box. Each participant in the study takes a piece of paper from the box and depending on whether the number written on it is even or odd, they are placed in one of the two test or control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Suicidal patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Sessions of the meaning therapy program during 6 sessions of 45 minutes and 3 times in each week and in the form of groups of eight to ten patients by researcher for the intervention group in the classroom will be conducted. The educational content of the sessions will be prepared based on the existing texts and Viktor Frankl's semantic therapy theory and Hotzel plan. The titles of the sessions include familiarity with logo therapy and the need for meaning in life, belief and acceptance of oneself and recognition of one's own characteristics, attention to spiritual freedom as one of the dimensions of human existence, awareness of responsibility, recognition of stress and its factors and ways Reducing and dealing with it, recognizing existential anxiety, the importance of communicating with others and maintaining it, examining the meaning of suffering, overcoming despair and hopelessness, and recognizing values. Intervention 2: Control group: It should be noted that no special intervention will be implemented for the control group. At the end of the program, in order to comply with ethics in research we will provide them with the content of the training sessions.</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>Mahgol Nasr Esfahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezarjerib Ave., Isfahan, Iran</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 7565</telephone>
        <email>mahgolnasrr@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahgol Nasr Esfahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University Of Medical Sciences, Hezar-Jerib Ave., Isfahan, IR Iran.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 7565</telephone>
        <email>mahgolnasrr@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patient should be interested and consent to participate in the study
Being diagnosed with suicide by a psychiatrist and admitted to one of the departments of Khorshid or Farabi hospitals
The patient must be at least 18 years old
Have the ability to read, write and speak Persian</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient has previously received interventions similar to this study
The patient has psychiatric disorders such as schizophrenia, schizoaffective, schizophreniform, delirium and substance use disorder</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: Sessions of the meaning therapy program during 6 sessions of 45 minutes and 3 times in each week and in the form of groups of eight to ten patients by researcher for the intervention group in the classroom will be conducted. The educational content of the sessions will be prepared based on the existing texts and Viktor Frankl's semantic therapy theory and Hotzel plan. The titles of the sessions include familiarity with logo therapy and the need for meaning in life, belief and acceptance of oneself and recognition of one's own characteristics, attention to spiritual freedom as one of the dimensions of human existence, awareness of responsibility, recognition of stress and its factors and ways Reducing and dealing with it, recognizing existential anxiety, the importance of communicating with others and maintaining it, examining the meaning of suffering, overcoming despair and hopelessness, and recognizing values.</i_keyword>
      <i_keyword>Control group: It should be noted that no special intervention will be implemented for the control group. At the end of the program, in order to comply with ethics in research we will provide them with the content of the training sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Motivations for suicide attempts in suicidal patients. Timepoint: At the beginning of the study (before the start of the intervention), immediately after the intervention and one month after the intervention. Method of measurement: May and Klonsky Inventory of Motivations for Suicide Attempts.</prim_outcome>
      <prim_outcome>Distress tolerance in suicidal patients. Timepoint: At the beginning of the study (before the start of the intervention), immediately after the intervention and one month after the intervention. Method of measurement: Simons and Gaher Distress Tolerance 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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-11</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Iran, Isfahan, Hazar Jarib St., Isfahan University of Medical Sciences, Research Assistant Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
