<?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>IRCT20250219064773N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-19</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effectiveness of mindfulness-based schema therapy on the level of suicidal ideation, self-criticism, self-disgust, and psychological inflexibility in individuals with suicidal ideation.</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of mindfulness-based schema therapy on the level of suicidal ideation, self-criticism, self-disgust, and psychological inflexibility in individuals with suicidal ideation.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82147</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Other, Randomization description: groups: the experimental group (receiving mindfulness-based schema therapy) and the control group. Simple randomization using a table of random numbers was employed for group allocation. First, a list of eligible participants was prepared, and each individual was assigned a unique number. Then, starting from a randomly selected point in the random number table, the numbers were read sequentially. Based on whether the number was even or odd, participants were assigned to either the experimental group (even numbers) or the control group (odd numbers). This method was used to prevent allocation bias and to enhance the internal validity of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Individuals with suicidal ideation.</hc_freetext>
      <i_freetext>Intervention Group: The intervention group will receive 8 sessions of 90-minute mindfulness-based schema therapy based on the protocol presented by Michael van Vreeswijk and colleagues..</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 Due to the preservation of confidentiality, raw data will not be published.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Zahra Zanjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan University of Medical Sciences, Pezeshk Blvd, Qotb Ravandi Blvd, Kashan, Isfahan Province, Iran.</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973474</zip>
        <telephone>+98 31 5510 9999</telephone>
        <email>z-zanjani2005@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Zahra Zanjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan University of Medical Sciences, Pezeshk Blvd, Qotb Ravandi Blvd, Kashan, Isfahan Province, Iran.</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973474</zip>
        <telephone>+98 31 5510 9999</telephone>
        <email>z-zanjani2005@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Individuals with suicidal ideation (score of 4-14 on the Beck Scale for Suicidal Ideation).
Having a minimum level of reading and writing literacy.
Having motivation and informed consent to participate in the research.
Non-substance use.
Not having a plan to attempt suicide.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a plan to attempt suicide.
Occurrence of a suicide attempt.
Need for a change in the treatment process.
Lack of willingness to cooperate.</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>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: The intervention group will receive 8 sessions of 90-minute mindfulness-based schema therapy based on the protocol presented by Michael van Vreeswijk and colleagues.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mindfulness-based schema therapy has a positive effect on reducing the level of suicidal ideation in individuals with such thoughts. Timepoint: Measurement will occur initially before the start of therapy sessions and immediately after the completion of therapy sessions. Method of measurement: Suicidal Ideation: The Beck Scale for Suicidal Ideation (BSS) standard questionnaire will be used to assess the intensity and frequency of suicidal thoughts at pre-test and post-test.Self-Criticism: The Levels of Self-Criticism Scale (LOSC) standard questionnaire by Thompson and  Zuroff  will be used at pre-test and post-test.Self-Disgust: The Self-Disgust Scale-Revised (SDS-R) standard questionnaire by Powell et al. will be used at pre-test and post-test.Psychological Inflexibility: The Acceptance and Action Questionnaire-II (AAQ-II) standard questionnaire by Bond et al. will be used at pre-test and post-test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mindfulness-based schema therapy has a positive effect on reducing the level of suicidal ideation in individuals with such thoughts. Timepoint: Pre-test: Before the start of the intervention. Post-test: After the completion of therapy sessions. Method of measurement: suicidal Ideation: Measurement Tool: Beck Scale for Suicidal Ideation (BSSI)Method: Using the standard 19-item BSSI questionnaire to assess the intensity and frequency of suicidal thoughts at pre-test and post test. Self-Criticism: Measurement Tool: Levels of Self-Criticism Scale (LOSC) by Thompson and Zuroff (22 items)Method: Scoring the Levels of Self-Criticism Scale to measure the degree of self-criticism in participating individuals at pre-test and post-test.                                          Psychological Inflexibility: Measurement Tool: Acceptance and Action Questionnaire-II (AAQ-II) by Bond et al. (10 items)Self-Disgust: Self-Disgust Scale-Revised (SDS-R) by Powell and colleagues... (The sentence is incomplete here.).</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-02-23</approval_date>
        <contact_name>Ethics Committee of Kashan University of Medical Sciences.</contact_name>
        <contact_address>Kashan University of Medical Sciences, Pezeshk Blvd, Qotb Ravandi Blvd, Kashan, Isfahan Province, Iran. Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
