<?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>IRCT20251020067691N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-11-19</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of mentalization therapy on improving negative metacognitive beliefs, rejection sensitivity, and feelings of shame in individuals with avoidant personality traits</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of mentalization therapy on metacognitive beliefs, rejection sensitivity, emotion of shame, and psycho-social flexibility between the individuals with avoidant personality syndrome.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/87021</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be allocated to either the intervention or control group using simple randomization. After confirming eligibility and obtaining informed consent, each participant will be assigned a random number between 0 and 1 generated by a computer program (Excel) . Participants with a number ≤ 0.5 will be placed in the intervention group, and those with a number &gt; 0.5 in the control group.

To ensure unbiased allocation, the randomization sequence will be generated by an independent researcher not involved in recruitment. The sequence will be stored in a coded list to maintain allocation concealment. The principal investigator responsible for participant enrollment will remain unaware of group assignments until allocation.

Whenever possible, the post-test outcome assessor will be blinded to group allocation to minimize assessment bias.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Avoidant Personality Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Mental Reconstruction-Based Therapy Group: The goal of mental reconstruction-based therapy is to establish balance in addressing the issues of individuals with avoidant personality disorder symptoms by enhancing their capacity for awareness of mental states influenced by dysfunctional metacognitive beliefs, sensitivity to rejection, feelings of shame, and their level of psychological-social flexibility. The interventions lasted for 8 weeks. Sessions were held twice a week, each lasting two hours. The sessions included the following topics: the concept of mental reconstruction, understanding problems related to mental reconstruction, why we have emotions and their basic types, how to record and regulate emotions, the relationship between mental reconstruction and emotions, the importance of mental reconstruction, the concept of personality disorders and avoidant personality disorder, and the application of mental reconstruction-based therapy. Intervention 2: Control group: No psychotherapy intervention: Subjects in this group did not receive individual or group psychological interventions.</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:
Demographic data and primary outcome results of the study can be shared after anonymization and ensuring individuals' privacy.

When:
Data can be made available 4 months after publication of the results and after the removal of personal identifying information.

To whom:
Data and study documentation will be available to researchers and scholars working at reputable academic and scientific institutions.

Conditions:
Research data and documentation are available for scientific and research purposes. Users must commit to keeping non-identifiable data confidential.

Where to obtain:
For data inquiries, please contact via email at farid.manouchehry97@gmail.com.

How to obtain:
After receiving the request and reviewing it by the researcher, a response will be provided as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farid Manouchehry</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Najafabad., Daneshgah Blvd., Najafabad., Isfahan., Iran.</address>
        <city>Najafabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8514143131</zip>
        <telephone>+98 913 294 4969</telephone>
        <email>farid.manouchehry97@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gholamreza Talebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Najafabad., Daneshgah Blvd., Najafabad., Iran.</address>
        <city>Najafabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8514143131</zip>
        <telephone>+98 913 317 0681</telephone>
        <email>rezatalebi@iau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>including avoidant personality syndrome
Age between 20-40 y.o.
Having at least a high school diploma</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Presence of psychological disorders such as bipolar disorder with manic or hypomanic episodes, or a history of schizophrenia diagnosis.
Presence of substance use disorder (abuse or dependence) within the past six months.
Presence of active suicidal ideation or a suicide attempt within the past six months.
Presence of intellectual disability or borderline intellectual functioning (IQ &lt; 70 or clinical diagnosis).
Inability to read, write, or complete self-report questionnaires.
Receiving individual psychotherapy at the time of screening.
Lack of willingness or inability to provide voluntary and informed consent.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F60.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Avoidant personality disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Mental Reconstruction-Based Therapy Group: The goal of mental reconstruction-based therapy is to establish balance in addressing the issues of individuals with avoidant personality disorder symptoms by enhancing their capacity for awareness of mental states influenced by dysfunctional metacognitive beliefs, sensitivity to rejection, feelings of shame, and their level of psychological-social flexibility. The interventions lasted for 8 weeks. Sessions were held twice a week, each lasting two hours. The sessions included the following topics: the concept of mental reconstruction, understanding problems related to mental reconstruction, why we have emotions and their basic types, how to record and regulate emotions, the relationship between mental reconstruction and emotions, the importance of mental reconstruction, the concept of personality disorders and avoidant personality disorder, and the application of mental reconstruction-based therapy.</i_keyword>
      <i_keyword>Control group: No psychotherapy intervention: Subjects in this group did not receive individual or group psychological interventions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of Avoidant Personality Disorder. Timepoint: Before the intervention, immediately after the intervention, and two months after the intervention. Method of measurement: Avoidant Personality Disorder Severity Index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Metacognitive Beliefs. Timepoint: Before, immediately after, and two months after the intervention. Method of measurement: Meta-Cognition Questionnaire(MCQ-30).</sec_outcome>
      <sec_outcome>Rejection Sensitivity. Timepoint: Before, immediately after, and two months after the intervention. Method of measurement: Interpersonal sensitivity Questionnaire( IPSM-32).</sec_outcome>
      <sec_outcome>Shame Emotion. Timepoint: Before, immediately after, and two months after the intervention. Method of measurement: Guilt and Shame Proneness scale(GASP).</sec_outcome>
      <sec_outcome>Psycho-Social Flexibility. Timepoint: Before, immediately after, and two months after the intervention. Method of measurement: Multidimensional Psychological Flexibility Inventory-24.</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>2025-07-31</approval_date>
        <contact_name>Ethics committee of Islamic Azad University of Najafabad</contact_name>
        <contact_address>Islamic Azad University of Najafabad., Daneshgah Blvd., Najafabad., Isfahan., Iran. Najafabad Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
