<?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>IRCT20230228057557N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-21</date_registration>
      <primary_sponsor>Shahid Chamran University of Ahvaz</primary_sponsor>
      <public_title>The Effect of Integrating Psychodrama with Cognitive Behavioral Group Therapy on Fear of Negative Evaluation, Interpersonal Sensitivity and Focused Attention in Female Adolescences with Social Anxiety Disorder</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Integrating Psychodrama with Cognitive Behavioral Group Therapy on Fear of Negative Evaluation, Interpersonal Sensitivity and Focused Attention in Female Adolescences with Social Anxiety Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69043</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The statistical population of this research included all ninth grade female students of the first secondary level who were studying in the public schools of this city in the academic year 1401-1402. The sampling method was a two-stage cluster, so that first, in the city, which has two municipal districts, one girl's school of the first secondary period was selected from each district, and in the next stage, students were selected from among the three grades of students. 9th grade was selected and they were screened with test tools.

According to the 13% prevalence of social anxiety, 200 questionnaires (based on normal distribution) were administered, and then among the respondents, 24 people qualified according to the cut-off score of the social anxiety scale and other test tools as well as the diagnostic interview according to DSM-5. Those who were required and volunteered to participate in the research were selected and randomly replaced in two groups of 12 people (experimental and control).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Social Anxiety Disorder.</hc_freetext>
      <i_freetext>Intervention group: Treatment begins with a social anxiety pre-test as well as an individual interview based on DSM-5 in which group therapy procedures and fear of participating in group sessions are discussed. This interview prepares subjects for group sessions and introduces them to the therapist (Heimberg &amp; Becker, 2002). In this experiment, we have 12 sessions. Sessions 1 and 2 are dedicated to creating a safe space where subjects can share their feelings and thoughts with each other and form a cohesive group. The first and second sessions are based on the group cognitive behavioral therapy protocol of Heimberg and Becker (2002), which are considered as basic training in cognitive restructuring .Sessions 3 to 11 are dedicated to psychodrama treatment techniques for social anxiety disorder and interpersonal sensitivity - self-focused attention and fear of negative evaluation, which includes four stages of warm-up and preparation, implementation, participation, and summary and analysis .Considering that the psychodrama approach is implemented from the third session, before entering the psychodrama, the therapist first completed the tasks of the previous stages, which included identifying negative spontaneous thoughts and identifying and naming cognitive errors; It reviews and summarizes and also the Socratic questioning technique is taught to help the subjects to find more logical answers. Then the stages of psychodrama begin. The first step in psychodrama is warming up; Preparation or warm-up is an activity that has a dramatic nature and causes spontaneity, concentration, and the revelation of the problem; In this stage, the goal is to create a safe, supportive and creative atmosphere at the beginning of each session by using warm-up techniques so that the subjects' ice melts and they are ready for the performance stage. At the end of this stage, the protagonist (first person or hero) should to be chosen to play a role in the performance stage, although sometimes the therapist can choose the first person, but most of the time the first person is determined by the amount of anxiety expressed verbally or non-verbally during the warm-up stage (while performing preparation techniques) . The twelfth session is dedicated to the summation and implementation of the post-examination..</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 Still undecided - no release schedule yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Kooraki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz; Golestan Blvd., Shahid Chamran University, Ahvaz, Faculty of Educational Sciences and Psychology</address>
        <city>Khuzestan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135783151</zip>
        <telephone>+98 913 845 4197</telephone>
        <email>m-kooraki@stu.scu.ac.ir</email>
        <affiliation>Shahid Chamran University of Ahvaz</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Kooraki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz; Golestan Blvd., Shahid Chamran University, Ahvaz, Faculty of Educational Sciences and Psychology</address>
        <city>Khuzestan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135783151</zip>
        <telephone>+98 913 845 4197</telephone>
        <email>m-kooraki@stu.scu.ac.ir</email>
        <affiliation>دانشگاه شهید چمران اهواز</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having social anxiety disorder based on the screening score in the research instrument and clinical interview based on DSM-5, expressing willingness and informed consent to participate in the research, adhering to group rules such as confidentiality, respecting other group members and attending group meetings on time. Studying in one of the girls' schools and the absence of concurrent mental disorders such as depression.</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>15 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Criteria for dropping out of the study: absence of more than two sessions, dropping out of school, not cooperating with the therapist and other members of the group, receiving any other training or treatment during the research period.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F93.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>In this disorder there is a wariness of strangers and social apprehension or anxiety when encountering new, strange, or socially threatening situations. This category should be used only where such fears arise during the early years, and are both unusual </hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Treatment begins with a social anxiety pre-test as well as an individual interview based on DSM-5 in which group therapy procedures and fear of participating in group sessions are discussed. This interview prepares subjects for group sessions and introduces them to the therapist (Heimberg &amp; Becker, 2002). In this experiment, we have 12 sessions. Sessions 1 and 2 are dedicated to creating a safe space where subjects can share their feelings and thoughts with each other and form a cohesive group. The first and second sessions are based on the group cognitive behavioral therapy protocol of Heimberg and Becker (2002), which are considered as basic training in cognitive restructuring .Sessions 3 to 11 are dedicated to psychodrama treatment techniques for social anxiety disorder and interpersonal sensitivity - self-focused attention and fear of negative evaluation, which includes four stages of warm-up and preparation, implementation, participation, and summary and analysis .Considering that the psychodrama approach is implemented from the third session, before entering the psychodrama, the therapist first completed the tasks of the previous stages, which included identifying negative spontaneous thoughts and identifying and naming cognitive errors; It reviews and summarizes and also the Socratic questioning technique is taught to help the subjects to find more logical answers. Then the stages of psychodrama begin. The first step in psychodrama is warming up; Preparation or warm-up is an activity that has a dramatic nature and causes spontaneity, concentration, and the revelation of the problem; In this stage, the goal is to create a safe, supportive and creative atmosphere at the beginning of each session by using warm-up techniques so that the subjects' ice melts and they are ready for the performance stage. At the end of this stage, the protagonist (first person or hero) should to be chosen to play a role in the performance stage, although sometimes the therapist can choose the first person, but most of the time the first person is determined by the amount of anxiety expressed verbally or non-verbally during the warm-up stage (while performing preparation techniques) . The twelfth session is dedicated to the summation and implementation of the post-examination.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social anxiety - interpersonal sensitivity - fear of negative evaluation and self-focused attention. Timepoint: Before starting the study, social anxiety-interpersonal sensitivity-focused attention-fear of negative evaluation was evaluated and the intervention was implemented twice a week for 12 sessions and followed up after one month. Method of measurement: 1- Adolescent Social Anxiety Scale (SASA) 2- Short Form of Fear of Negative Evaluation (FNEB) 3- Interpersonal Sensitivity Questionnaire 4- Focus of Attention Scale (FAQ).</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>Shahid Chamran University of Ahvaz</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-06</approval_date>
        <contact_name>Ethics committee of Shahid Chamran University of Ahvaz</contact_name>
        <contact_address>Ahvaz, Golestan Boulevard, Shahid Chamran University of Ahvaz.Faculty of Educational Sciences and Psychology, Shahid Chamran University, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
