<?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>IRCT20260513069386N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-05-21</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effec of Mentalization Treatment on Emotion Regulation, Psychological Distress, and Resilience</public_title>
      <acronym>MBT</acronym>
      <scientific_title>The Effectiveness of Mentalization-Based Treatment (MBT) on Emotion Regulation, Psychological Distress, and Resilience in Adolescents with Childhood Trauma and Externalizing Symptoms</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/90246</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Initially, based on the entry criteria, 40 subjects will be selected purposively and then, using a simple random method, the subjects will be assigned to two groups of 20, the experimental and control groups. Regarding the method of drawing lots, one name from each name bag will be placed in the experimental group and the next name will be placed in the control group.</study_design>
      <phase>1</phase>
      <hc_freetext>Condition 1: Emotion Regulation. Condition 2: Psychological Distress. Condition 3: Resilience.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Based on the mentalization-based therapy intervention approach derived from the Malberg protocol (2021), they will receive 8 intensive sessions (2 hours) over a period of two months (one session per week). Intervention 2: Control group: After the pre-test, this group was left free for two months and then re-tested.</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:
All information and data collected, after being de-identified, will be shared to assist in relevant studies and future research.

When:
Data access will begin 6 months after the results are published.

To whom:
Psychology professors, researchers, and students are allowed to request data and other documentation.

Conditions:
The data will be used to develop future research results and meta-analyses.

Where to obtain:
Applicants can contact the corresponding author's academic email address to receive the data. ailar.akbari@iau.ir

How to obtain:
After submitting their application, applicants will be able to receive the data within one month by attaching research documentation demonstrating the necessity of the data to achieve the research goals.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ailar Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 21, Sub-section 16/1, Alley 16, Abavardi Ave, Chamran Blvd.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194744759</zip>
        <telephone>+98 71 3627 9125</telephone>
        <email>ailar.akbari@iau.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Fatemeh Ghanbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 9, 2nd floor, Shiraz Mehr Medical Complex, Alley 6, Shahid Jamali St., Molla Sadra St.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۱۹۳۶۱۶۱۳۸</zip>
        <telephone>+98 71 9361 6138</telephone>
        <email>ghanbari.f@iau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having externalizing symptoms based on the Achenbach Child Behavioral Inventory
Power to participate in the research (informed consent)
Adolescents in the age range (12 to 18 years)</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cancellation of further cooperation
Absence of more than two sessions of concurrent participation in similar psychotherapy programs or emotion-based interventions, which could affect the results of the study.
History of receiving psychological interventions and taking psychiatric medications within the past 6 months
Diagnosis of chronic and severe psychological disorders (major depression, bipolar disorders, conduct disorder, psychotic disorders, and personality disorders)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Based on the mentalization-based therapy intervention approach derived from the Malberg protocol (2021), they will receive 8 intensive sessions (2 hours) over a period of two months (one session per week).</i_keyword>
      <i_keyword>Control group: After the pre-test, this group was left free for two months and then re-tested.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotion Regulation. Timepoint: Emotional regulation was measured before the intervention began and a second time, two months after the intervention period, was measured at the post-test. Method of measurement: Gross and John's Emotion Regulation Questionnaire (2003).</prim_outcome>
      <prim_outcome>Psychological Distress. Timepoint: psychological distress was measured before the intervention began and a second time, two months after the intervention period, was measured at the post-test. Method of measurement: Kessler et al.'s Psychological Distress Questionnaire (2003).</prim_outcome>
      <prim_outcome>Resilience. Timepoint: resilience was measured before the intervention began and a second time, two months after the intervention period, was measured at the post-test. Method of measurement: Connor and Davidson's Resilience Questionnaire (2003).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Childhood trauma. Timepoint: Childhood trauma was measured before the intervention began and a second time, two months after the intervention period, was measured at the post-test. Method of measurement: Achenbach's Child Behavioral Inventory (CBCL) (1991).</sec_outcome>
      <sec_outcome>Externalizing symptoms. Timepoint: externalizing symptoms was measured before the intervention began and a second time, two months after the intervention period, was measured at the post-test. Method of measurement: Bernstein et al.'s Childhood Trauma Questionnaire (CTQ) (2003).</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-05-13</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of Shiraz</contact_name>
        <contact_address>Faculty of Dentistry, Alley 14, South Ghaani Street Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
