<?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>IRCT20240616062146N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-03</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of cognitive behavioral therapy in adolescents with social anxiety symptom</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of cognitive behavioral therapy in fear of negative evaluation, self-criticism, and self-focused attention in adolescents with social anxiety symptom</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77411</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Available selection and random assignment by lottery method in two blocks of experimental group and control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Social anxiety disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The experimental group of 15 adolescent girls with symptoms of social anxiety disorder in Sari city was selected in a non-random and accessible manner based on the inclusion criteria. Before implementing the intervention, three questionnaires of fear of negative evaluation, self-focused attention and self-criticism were taken from them. Then they received eight 90-minute sessions of cognitive behavioral therapy based on the Heimberg and Becker protocol. Intervention 2: Control group: The control group of 15 teenage girls with symptoms of social anxiety disorder in Sari city was selected in a non-random and accessible manner based on the inclusion criteria. At the beginning of the work, at the same time as the experimental group, three questionnaires of fear of negative evaluation, self-focused attention and self-criticism were taken from them, and this group did not receive any intervention. After the experimental group received the intervention, questionnaires were taken again from both the control group and the experimental 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only a part of the data, such as the information related to the main outcome or the like, can be shared

When:
Access starts 6 months after results are published

To whom:
Researchers working in academic and scientific institutions can access the data

Conditions:
We have not considered other conditions.

Where to obtain:
Dr. Maede Bagheri
09113546226
Mbagheri66.mb@gmail.com

How to obtain:
The applicant can receive the documents by submitting the code of ethics and sending her request to the mentioned email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh zahra sedaghat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No, 481567896. shamshirband20 Ave. Shamshirband Blvd , Sari town</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815678596</zip>
        <telephone>+98 11 3339 0832</telephone>
        <email>sedaghatfatem9@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh zahra sedaghat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No, 481567896. shamshirband20 Ave. Shamshirband Blvd , Sari town</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815678596</zip>
        <telephone>+98 11 3339 0832</telephone>
        <email>sedaghatfatem9@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 13 and 15
completing the informed consent agreement regarding participation in the research project
not having a substance use disorder
have social anxiety symptoms (based on the Lajerka adolescent anxiety questionnaire and structured clinical interview based on DSM 5 criteria by a psychiatrist
Not suffering from psychiatric disorders based on a structured clinical interview based on DSM 5 criteria by a psychiatrist.
Not suffering from vision and hearing problems so that the person cannot participate in the treatment process and complete the questionnaires.
Absence of acute and chronic physical diseases.</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>15 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Absence of more than one treatment session
- Failure to do homework in more than one session
Unwillingness to continue participating in the treatment process for any reason.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Social anxiety disorder</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: The experimental group of 15 adolescent girls with symptoms of social anxiety disorder in Sari city was selected in a non-random and accessible manner based on the inclusion criteria. Before implementing the intervention, three questionnaires of fear of negative evaluation, self-focused attention and self-criticism were taken from them. Then they received eight 90-minute sessions of cognitive behavioral therapy based on the Heimberg and Becker protocol.</i_keyword>
      <i_keyword>Control group: The control group of 15 teenage girls with symptoms of social anxiety disorder in Sari city was selected in a non-random and accessible manner based on the inclusion criteria. At the beginning of the work, at the same time as the experimental group, three questionnaires of fear of negative evaluation, self-focused attention and self-criticism were taken from them, and this group did not receive any intervention. After the experimental group received the intervention, questionnaires were taken again from both the control group and the experimental group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of negative evaluation. Timepoint: Measuring the fear of negative evaluation at the beginning of the study (before the start of the intervention) and after the end of the cognitive behavioral therapy sessions. Method of measurement: Brief Fear of Negative Evaluation Scale Leary (1983).</prim_outcome>
      <prim_outcome>Self _focused attention. Timepoint: Measuring self-focused attention at the beginning of the study (before the start of the intervention) and after the end of the cognitive behavioral therapy sessions. Method of measurement: In the focus of attention questionnaire of Woody, Chambless and Glass (1997).</prim_outcome>
      <prim_outcome>Self-criticism. Timepoint: Measuring self-criticism at the beginning of the study (before the start of the intervention) and after the end of the cognitive behavioral therapy sessions. Method of measurement: The Levels of Self-Criticism Scale (LOSC; Thompson &amp; Zuroff, 2004).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fear score of negative evaluation. Timepoint: The time periods of measuring the fear of negative evaluation at the beginning of the study and after the end of the intervention. Method of measurement: 12-item short form questionnaire (FNES-B).</sec_outcome>
      <sec_outcome>Self-focused attention score. Timepoint: The time periods of measuring the amount of self-focused attention at the beginning of the study and after the end of the intervention. Method of measurement: A 10-question questionnaire is the focus of attention.</sec_outcome>
      <sec_outcome>Self-criticism. Timepoint: The time periods of measuring the amount of self-criticism at the beginning of the study and after the end of the intervention. Method of measurement: 22-question questionnaire (LOSC).</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>2023-09-09</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University</contact_name>
        <contact_address>No, 481567896. shamshirband20 Ave. Shamshirband Blvd , Sari town Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
