<?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>IRCT20220406054427N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-25</date_registration>
      <primary_sponsor>Refah University College</primary_sponsor>
      <public_title>Evaluation of the effectiveness of interactive meta-diagnostic software for social anxiety disorder</public_title>
      <acronym></acronym>
      <scientific_title>Design and validation of the effectiveness of interactive meta-diagnostic treatment software for social anxiety disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>6</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63890</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Social Anxiety Disorder.</hc_freetext>
      <i_freetext>Intervention group: The aim of this study was to design and evaluate the validity of effective interactive meta-diagnostic treatment software for social anxiety disorder. Sampling of the intervention group was purposeful and voluntary. In this study, 6 people will be individually trained with interactive software made of 8 sessions of treatment. Participants from the Umm al-Imam School in Robat Karim must be suffering from social anxiety. Age between 15 and 18 years, absence of comorbidity disorder and medication and other intervention during the study were the criteria for admission and not participating in more than two sessions of treatment and use of medication or other treatment during the study were among the exclusion criteria. Interactive software: This software designed in Android environment with Java programming language includes meta-diagnostic treatment methods for social anxiety disorder 1. The software includes the test section of Connor Social Panic Questionnaire, if a person gets a score above 20, he has a disorder. 2. The next step is the diagnostic interview based on DSM-5 criteria. If a person has a disorder syndrome, the system will give him feedback.3. Then we specify the goal setting table for the references. What are the advantages and disadvantages of changing or not? 4. In the next step: we try to gain an understanding of the emotions and behavioral behaviors of the clients. Understanding emotions and behaviors means understanding a person's antecedents, responses, and repetitive behaviors, which he or she repeats when he or she becomes emotional. 5. Teaching emotion and excitement. People with emotional disorders always want to suppress their emotions by avoiding it. In the next step, based on the perception of emotions and behaviors of the individual, we determine the behaviors caused by emotion. Our goal is to identify behaviors that evoke emotion, to identify and correct behaviors that occur subconsciously when experiencing anxiety. 7. Practice mindfulness and being in the here and now at this stage is given to the authorities. Practicing judgment and non-judgment is the last step in treatment. At this stage, the patient learns to distinguish between his judgment and non-judgment phases and realizes that he is the one who creates negative emotions for himself by judging..</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:
Interactive software will be provided to treatment clinics for use after completion and usability. The results and data of this study will be presented to clinical professionals and students in this field after correspondence and fact-checking.

When:
Up to one year after the publication of the article

To whom:
Clinical professionals and psychology students

Conditions:
To study anxiety disorders and integrated protocol treatment

Where to obtain:
Ms. Hashemi Mofrad to email: ms.hashemimofrad@gmail.com

How to obtain:
The applicant submits an email to the submitted email and provides his / her full details. The applicant must be a clinical specialist or a psychology student. The name of the university must be clear. After confirming the information, the applicant would send the information to him.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdeh Sadat Hashemi Mofrad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gol Mohammadi Street,  beginning of People's Street, Baharestan,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>11575138</zip>
        <telephone>+98 21 3507 4338</telephone>
        <email>ms.hashemimofrad@gmail.com</email>
        <affiliation>Refah University College</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ghazal Zandkarimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gol Mohammadi Street,  beginning of People's Street, Baharestan</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>11575138</zip>
        <telephone>+98 21 3507 4315</telephone>
        <email>ghazalzandi@yahoo.com</email>
        <affiliation>Refah University College</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having social anxiety disorder
No other comorbid mental disorder due to clinical specialist approval
No use of arbitrator and other intervention at the same time as the course of treatment in this study</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No other comorbid mental disorders</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>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The aim of this study was to design and evaluate the validity of effective interactive meta-diagnostic treatment software for social anxiety disorder. Sampling of the intervention group was purposeful and voluntary. In this study, 6 people will be individually trained with interactive software made of 8 sessions of treatment. Participants from the Umm al-Imam School in Robat Karim must be suffering from social anxiety. Age between 15 and 18 years, absence of comorbidity disorder and medication and other intervention during the study were the criteria for admission and not participating in more than two sessions of treatment and use of medication or other treatment during the study were among the exclusion criteria. Interactive software: This software designed in Android environment with Java programming language includes meta-diagnostic treatment methods for social anxiety disorder 1. The software includes the test section of Connor Social Panic Questionnaire, if a person gets a score above 20, he has a disorder. 2. The next step is the diagnostic interview based on DSM-5 criteria. If a person has a disorder syndrome, the system will give him feedback.3. Then we specify the goal setting table for the references. What are the advantages and disadvantages of changing or not? 4. In the next step: we try to gain an understanding of the emotions and behavioral behaviors of the clients. Understanding emotions and behaviors means understanding a person's antecedents, responses, and repetitive behaviors, which he or she repeats when he or she becomes emotional. 5. Teaching emotion and excitement. People with emotional disorders always want to suppress their emotions by avoiding it. In the next step, based on the perception of emotions and behaviors of the individual, we determine the behaviors caused by emotion. Our goal is to identify behaviors that evoke emotion, to identify and correct behaviors that occur subconsciously when experiencing anxiety. 7. Practice mindfulness and being in the here and now at this stage is given to the authorities. Practicing judgment and non-judgment is the last step in treatment. At this stage, the patient learns to distinguish between his judgment and non-judgment phases and realizes that he is the one who creates negative emotions for himself by judging.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social Anxiety Disorder. Timepoint: Measurements will be performed twice at the beginning of the study, then each time after each treatment session, for a total of 8 measurements, and then after one month of follow-up re-measurements. Method of measurement: Social Panic Questionnaire (Connor, 2000).</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>Refah University College</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-06</approval_date>
        <contact_name>Ethics Committee of Al-Zahra University</contact_name>
        <contact_address>Alzahra University, Deh Vanak St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
