<?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>IRCT20230417057932N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-04</date_registration>
      <primary_sponsor>The University of Kurdistan</primary_sponsor>
      <public_title>The effectiveness of metacognitive therapy on social anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of metacognitive therapy on mind reading, Autobiographical memory and cognitive emotion regulation in students with social anxiety</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74956</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this manner, numerical ranging from 1 to 30 are randomly assigned to all participants in the research study. Subsequently, even numbers will be randomly assigned to one group, and odd numbers to another group. Finally, one of the groups will be randomly selected for the intervention group, while the other group will be designated as the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Social anxiety disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: In this study, the intervention group will receive 10 sessions of cognitive-behavioral therapy based on the protocol by Wells et al. (2009). Session 1: Introduction and preparation, implementation of the downward arrow technique, initiating challenge with dysfunctional beliefs, practicing fragmented mindfulness.Session 2: Continuing the challenge with dysfunctional beliefs, postponing worry.Session 3: Presenting opposing evidence, examining and stopping avoidant behaviors, reversing avoidant behaviors.Session 4: Initiating challenge with beliefs related to danger, attempting to lose control or harm oneself using the worry experiment. Session 5: Continuing the challenge with beliefs about the dangerousness of worry. Implementing the challenge experiment with beliefs related to danger in the therapy session.Session 6: Continuing the challenge with beliefs about danger, emphasizing reversing any remaining non-adaptive strategies, behavioral experiments to challenge beliefs about danger. Session 7: Initiating challenge with positive beliefs. Session 8: Continuing the challenge with positive beliefs. Implementing the non-compliance strategy in the therapy session. Session 9: Working on reversing remaining symptoms. Implementing the effective strategy, initiating work on a new plan.Session 10: Working on the treatment plan (preventing relapse), strengthening the alternative plan, and explaining it clearly with examples. Intervention 2: Control Group: In this study, the control group will participate in pre-test, post-test, and follow-up assessments, but no intervention will be implemented for this group.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Anvar Dastbaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 64, Kurdistan of University, Pasdaran Blvd., Sanandaj, Iran.</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617715175</zip>
        <telephone>+98 87 3366 4600</telephone>
        <email>Anvardastbaz@uok.ac.ir</email>
        <affiliation>University of Kurdistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Anvar Dastbaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 64, Kurdistan of University, Pasdaran Blvd., Sanandaj, Iran.</address>
        <city>Sanandej</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617715175</zip>
        <telephone>+98 87 3366 4600</telephone>
        <email>Anvardastbaz@uok.ac.ir</email>
        <affiliation>University of Kurdistan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Middle school students and attendance in school during the research period
Being in the age range of 14 to 18 years
Being diagnosed with social anxiety disorder, determined through the Liebowitz Social Anxiety Scale (1998) and an interview conducted by an experienced psychologist following the criteria of DSM-5-TR</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a chronic and disabling medical condition
Having concurrent comorbid mental disorders
Participating in similar courses either in the past or concurrently with the independent variable
Consumption of neurologic and psychiatric medications</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Social phobias</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: In this study, the intervention group will receive 10 sessions of cognitive-behavioral therapy based on the protocol by Wells et al. (2009). Session 1: Introduction and preparation, implementation of the downward arrow technique, initiating challenge with dysfunctional beliefs, practicing fragmented mindfulness.Session 2: Continuing the challenge with dysfunctional beliefs, postponing worry.Session 3: Presenting opposing evidence, examining and stopping avoidant behaviors, reversing avoidant behaviors.Session 4: Initiating challenge with beliefs related to danger, attempting to lose control or harm oneself using the worry experiment. Session 5: Continuing the challenge with beliefs about the dangerousness of worry. Implementing the challenge experiment with beliefs related to danger in the therapy session.Session 6: Continuing the challenge with beliefs about danger, emphasizing reversing any remaining non-adaptive strategies, behavioral experiments to challenge beliefs about danger. Session 7: Initiating challenge with positive beliefs. Session 8: Continuing the challenge with positive beliefs. Implementing the non-compliance strategy in the therapy session. Session 9: Working on reversing remaining symptoms. Implementing the effective strategy, initiating work on a new plan.Session 10: Working on the treatment plan (preventing relapse), strengthening the alternative plan, and explaining it clearly with examples.</i_keyword>
      <i_keyword>Control Group: In this study, the control group will participate in pre-test, post-test, and follow-up assessments, but no intervention will be implemented for this group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mind reading. Timepoint: Pre-test (before intervention), post-test (after intervention), follow-up (2 months after intervention). Method of measurement: Baron-Cohen mind reading test (2001).</prim_outcome>
      <prim_outcome>Autobiographical memory. Timepoint: Pre-test (before intervention), post-test (after intervention), follow-up (2 months after intervention). Method of measurement: Autobiographical Memory Test (AMT), Williams and Broadbent (1986).</prim_outcome>
      <prim_outcome>Cognitive emotion regulation. Timepoint: Pre-test (before intervention), post-test (after intervention), follow-up (2 months after intervention). Method of measurement: Garnevsky and Kraij (2006) cognitive emotion regulation 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>The University of Kurdistan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-23</approval_date>
        <contact_name>Research Ethics Committees of University of Kurdistan</contact_name>
        <contact_address>Central building, Kurdistan of University, Pasdaran Blvd., Sanandaj, Iran Sanandej Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
