<?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>IRCT20220113053705N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-07-09</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effectiveness of pharmacotherapy and Mindfulness-integrated Cognitive Behavior Therapy (MiCBT) on suicide</public_title>
      <acronym>Mindfulness integrated CBT (MiCBT)</acronym>
      <scientific_title>Comparing the effectiveness of pharmacotherapy and Mindfulness-integrated Cognitive Behavior Therapy (MiCBT) in suicidal adults following hospitalization</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84541</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selecting the participants, all of them will be randomly assigned to the control and intervention groups through a simple lottery method. To do this, each participant’s code will be written on identical cards, which will then be randomly drawn to allocate them to the two study groups. This way, all participants will have an equal chance of being placed in either group, Blinding description: The statistical evaluator of the results will be blinded to the group assignments and will not know which group is the intervention or control.</study_design>
      <phase>3</phase>
      <hc_freetext>Suicide.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group will receive 8 to 10 psychotherapy sessions based on the mindfulness-integrated cognitive-behavioral therapy protocol. Intervention 2: Control group: The control group will continue only their pre-prescribed medication treatment and will not receive any specific psychotherapy concurrently.</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:
Data related to the study will be provided in response to legitimate requests from the relevant organizations.

When:
6 month after publication of the related paper

To whom:
Academic researchers can access the data upon submitting a formal and justified request.

Conditions:
The individual must have a verified identity and submit the request through an official or academic organization. They must accept responsibility for maintaining confidentiality and not disclosing the data without permission, in accordance with ethical principles.

Where to obtain:
They can correspond via the following email to make a request: F.sohrabi20@gmail.com

How to obtain:
After receiving the email and reviewing it through official channels, the request will be responded to as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Fateh Sohrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Clinical Psychology Branch., Faculty of Medicine., Kurdistan University of Medical Sciences., Pasdaran Ave.</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66177-13141</zip>
        <telephone>+98 87 3366 4664</telephone>
        <email>F.sohrabi20@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Fateh Sohrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Clinical Psychology Branch., Faculty of Medicine., Kurdistan University of Medical Sciences., Pasdaran Ave.</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66177-13141</zip>
        <telephone>+98 87 3366 4664</telephone>
        <email>F.sohrabi20@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Providing consent to participate in the study,
Having at least middle school literacy,
Having a history of suicide attempts,
Absence of psychotic symptoms or intellectual/cognitive impairment,
No substance or alcohol dependence or abuse,
Not participating in any other psychotherapy simultaneously with the current study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Withdrawal from the study,
Substance or alcohol dependence or abuse,
Diagnosis of psychotic disorders,
Intellectual or cognitive impairment before or during the study,
Suicide attempts, and the need for hospitalization</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>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This group will receive 8 to 10 psychotherapy sessions based on the mindfulness-integrated cognitive-behavioral therapy protocol.</i_keyword>
      <i_keyword>Control group: The control group will continue only their pre-prescribed medication treatment and will not receive any specific psychotherapy concurrently.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Suicide. Timepoint: Measurement of suicide before the start of the intervention (Pre-assessment), after the completion of the intervention (Post-assessment), and two months after the last intervention session (Follow-up). Method of measurement: Beck Scale for Suicidal Ideation.</prim_outcome>
      <prim_outcome>Depression, Anxiety and Stress. Timepoint: Measurement of Depression,  Anxiety, and Stress before the start of the intervention (Pre-assessment), after the completion of the intervention (Post-assessment), and two months after the last intervention session (Follow-up). Method of measurement: Depression, Anxiety and Stress scale.</prim_outcome>
      <prim_outcome>Coping-Strategies. Timepoint: Measurement of Coping-Strategies before the start of the intervention (Pre-assessment), after the completion of the intervention (Post-assessment), and two months after the last intervention session (Follow-up). Method of measurement: Billings-and-Mouse-Coping-Strategies-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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-06-10</approval_date>
        <contact_name>Research Ethics Committees of Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Kurdistan University of Medical Sciences., Pasdaran Ave. Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
