<?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>IRCT20240930063208N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-18</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Investigating the effectiveness of metacognitive intervention based on mindfulness and mentalizing intervention on generalized anxiety disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of  metacognitive detached mindfulness intervention and mentalization based-therapy on intolerance of uncertainty, cognitive avoidance, emotion regulation, and attention of the conscious mind in children of veterans with generalized anxiety disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-12-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80472</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: First, 45 people from the target population will be selected purposefully according to the inclusion and exclusion criteria, and then each subject will be assigned to the first intervention group, the second intervention group, and the control group through simple randomization through drawing lots.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Intolerance of uncertainty. Condition 2: Cognitive avoidance. Condition 3: Emotion regulation. Condition 4: Attention of the conscious mind.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first intervention group includes subjects who will undergo metacognitive therapy based on dissociative mindfulness. This treatment includes an 8-session educational-therapeutic protocol that is implemented one day per week and each session lasts 60 minutes. In order to examine the effectiveness of the intervention, a research study will be conducted in the form of a pre-test, post-test, and a three-month follow-up period. Intervention 2: Intervention group:The second intervention group includes subjects who will undergo mentalization-based therapy. This treatment includes a 12-session educational-therapeutic protocol that is implemented one day per week and each session lasts 60 minutes. In order to examine the effectiveness of the intervention, a research study will be implemented in the form of a pre-test, post-test, and a three-month follow-up period. Intervention 3: Control group: The control group will consist of 15 subjects, for whom no intervention will be provided.</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 There is no need to disclose the personal information of participants in this study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sina erfanian majdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 14. Ayatollah meshkini 39</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9185379379</zip>
        <telephone>+98 51 3623 8391</telephone>
        <email>Sina.erfani888@gmail.com</email>
        <affiliation>Islamic Azad university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sina erfanian majdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 14. Ayatollah meshkini 39</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9185379379</zip>
        <telephone>+98 51 3623 8391</telephone>
        <email>Sina.erfani888@gmail.com</email>
        <affiliation>Islamic Azad university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with generalized anxiety disorder
Having at least a diploma
Child of a mentally ill veteran</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Comorbidity with psychotic disorders
Drug and medication abuse
Receiving psychological intervention within the past 6 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_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>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The first intervention group includes subjects who will undergo metacognitive therapy based on dissociative mindfulness. This treatment includes an 8-session educational-therapeutic protocol that is implemented one day per week and each session lasts 60 minutes. In order to examine the effectiveness of the intervention, a research study will be conducted in the form of a pre-test, post-test, and a three-month follow-up period.</i_keyword>
      <i_keyword>Intervention group:The second intervention group includes subjects who will undergo mentalization-based therapy. This treatment includes a 12-session educational-therapeutic protocol that is implemented one day per week and each session lasts 60 minutes. In order to examine the effectiveness of the intervention, a research study will be implemented in the form of a pre-test, post-test, and a three-month follow-up period.</i_keyword>
      <i_keyword>Control group: The control group will consist of 15 subjects, for whom no intervention will be provided.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intolerance of Uncertainty Score on the Freestone Questionnaire. Timepoint: Before and after the intervention, and three months after the intervention ended. Method of measurement: Freestone Intolerance of Uncertainty Questionnaire.</prim_outcome>
      <prim_outcome>Cognitive avoidance score in the Dagas questionnaire. Timepoint: Before and after the intervention, and three months after the intervention ended. Method of measurement: Dugas and Sexton Cognitive Avoidance Questionnaire.</prim_outcome>
      <prim_outcome>Emotional dysregulation score on the Gratz questionnaire. Timepoint: Before and after the intervention, and three months after the intervention ended. Method of measurement: Gratz and Romer's Difficulty in Emotion Regulation Questionnaire.</prim_outcome>
      <prim_outcome>Mindful attention score in the Brown Questionnaire. Timepoint: Before and after the intervention, and three months after the intervention ended. Method of measurement: Brown and Ryan Mindful Attention 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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-08-07</approval_date>
        <contact_name>Ethics Committee of the Faculty of Medicine, Islamic Azad University, Mashhad Medical Sciences Branc</contact_name>
        <contact_address>Islamic Azad University of Medical Sciences, Mashhad, Chamran 15 Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
