<?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>IRCT20260727070380N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-10-13</date_registration>
      <primary_sponsor>Torbate-Heidaria University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of mindfulness in depressed students.</public_title>
      <acronym></acronym>
      <scientific_title>The Efficacy of Mindfulness-Based Interventions on Psychological Distress in Depressed University Students with Suicidal Ideation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/91985</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: To control for confounding variables (gender and major) and ensure the homogeneity of the intervention and control groups, a ‘stratified randomization’ method will be employed. First, the list of all participants will be organized based on the combination of ‘gender’ (male/female) and ‘field of study’ (Midwifery, Nursing, Emergency Medical Services, Anesthesiology). Based on these combinations, 10 distinct and homogeneous strata will be formed. To generate the allocation sequence within each stratum, Microsoft Excel software will be used. A random number between 0 and 1 will be generated for every participant in each stratum and recorded in the column adjacent to their name. After assigning the random numbers, the list of participants in each stratum will be sorted in ascending order (from smallest to largest) based on the generated values. Subsequently, based on the resulting order, participants will be allocated to the intervention and control groups in a 1:1 ratio. For instance, in a stratum with 12 participants, the first 6 individuals on the sorted list will be assigned to the intervention group, and the remaining 6 to the control group. This process ensures that every participant within each stratum has an equal probability of being assigned to either group, thereby minimizing the impact of confounding variables on the final composition of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mindfulness-based therapy:. Intervention 2: Control group: Non-receipt of mindfulness-based therapy.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Individual participant data are not disclosed; only the aggregated group-level analysis of the therapeutic outcomes is presented.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>somaye mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Torbat Heydariyeh</address>
        <city>Torbat Heydariyeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9516115735</zip>
        <telephone>+98 51 5229 3742</telephone>
        <email>mohammadi.sm7241@gmail.com</email>
        <affiliation>Torbate-Heidaria University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>somaye mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Torbat Heydariyeh</address>
        <city>Torbat Heydariyeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9516115735</zip>
        <telephone>+98 51 5229 3746</telephone>
        <email>mohammadi.sm7241@gmail.com</email>
        <affiliation>Torbate-Heidaria University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A score between 1 and 5 on the Beck Scale for Suicide Ideation (BSS), indicating the presence of suicidal ideation.No use of psychiatric medications within the past three months.No diagnosis of severe mental disorders (e.g., schizophrenia or bipolar disorder) by a psychiatrist.Willingness to attend all intervention sessions.Signing the informed consent form.</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>27 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>A history of active suicide attempts within the past six months.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mindfulness-based therapy:</i_keyword>
      <i_keyword>Control group: Non-receipt of mindfulness-based therapy</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of psychological distress. Timepoint: Psychological distress will be measured at baseline, prior to the intervention. Method of measurement: will be measured using the Kessler Psychological Distress Scale (K10).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Suicide Ideation. Timepoint: will be measured at baseline, prior to the intervention. Method of measurement: Beck Suicide Ideation Scale (BSS).</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>Torbate-Heidaria University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-06-21</approval_date>
        <contact_name>Research Ethics Committee of Torbat Heydariyeh University of Medical Sciences</contact_name>
        <contact_address>Torbat Heydariyeh University of Medical Sciences, Salamat Town, Shahid Borounsi St., Torbat Heydariyeh, Iran Torbat Heydariyeh Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
