<?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>IRCT20250215064731N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-23</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparing the effectiveness of two therapy</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of mindfulness-based cognitive therapy and virtual reality-based anxiety exposure therapy on cognitive avoidance, emotional capital, hyper-emotion, and social self-efficacy in adolescents with social anxiety</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81911</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Experimental and control groups: After selecting the sample, the next step is to divide the people into experimental and control groups. For this, a simple random method can be used.

How to perform randomization:
Step 1: After selecting the purposive sample, all the selected people are placed in a list.

Step 2: From among these people, using a random method (such as drawing lots or using randomization software), people are divided into two experimental groups and a control group, Blinding description: In the study in question, all participants and clinical caregivers and evaluators who interpret and analyze the data are blinded, and the participants are unaware of each other, and an abbreviation is considered for each participant.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety disorder in adolescents.</hc_freetext>
      <i_freetext>Intervention 1: Mindfulness-based cognitive therapy Mindfulness can help prevent anxiety due to its underlying mechanisms, such as acceptance, increased awareness, desensitization, presence in the moment, nonjudgmental observation, daydreaming, and letting go. Intervention 2: Virtual Reality-Based Exposure Therapy for Anxiety Virtual reality exposure therapy is a standardized, exposure-based treatment approach that has been introduced as an alternative to classic cognitive-behavioral therapy. Virtual reality is defined as a situation in which sensory information is provided by a computer instead of the natural environment.</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 Participant data is completely confidential and I do not intend to publish it.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>solmaz choheili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 718, Khansari Street, Zand Street</address>
        <city>ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6195655344</zip>
        <telephone>+98 61 3221 0997</telephone>
        <email>solmaz_chohili@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>solmaz choheili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 718, Khansari Street, Zand Street</address>
        <city>ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6195655344</zip>
        <telephone>+98 61 3221 0997</telephone>
        <email>solmaz_chohili@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being in the age range of 15-17 years.
Participate in the research with informed consent.
Having social anxiety disorder based on a diagnostic interview and the Social Anxiety Scale questionnaire (achieving a minimum score of 50 on the test).
No concurrent clinical disorders and no dependence on alcohol or drugs.
Not receiving any other concurrent treatment.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>17 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absent more than two meetings.
Participants may withdraw from continuing treatment sessions.
The occurrence of severe stressful events in life (such as divorce or death of a first-degree relative).
Suffering from a physical disorder that requires hospitalization.
The presence of certain physical diseases such as heart, lung and respiratory diseases, epilepsy and seizures.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Mindfulness-based cognitive therapy Mindfulness can help prevent anxiety due to its underlying mechanisms, such as acceptance, increased awareness, desensitization, presence in the moment, nonjudgmental observation, daydreaming, and letting go.</i_keyword>
      <i_keyword>Virtual Reality-Based Exposure Therapy for Anxiety Virtual reality exposure therapy is a standardized, exposure-based treatment approach that has been introduced as an alternative to classic cognitive-behavioral therapy. Virtual reality is defined as a situation in which sensory information is provided by a computer instead of the natural environment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social anxiety is a specific and persistent fear of being embarrassed or negatively evaluated (scrutinized) in social situations or when performing an activity in front of others. Timepoint: It takes two months before and after the study begins. Method of measurement: The Adolescent Social Anxiety Scale was developed by Lajerka (1999).</prim_outcome>
      <prim_outcome>Experiential cognitive avoidance refers to an individual's attempt to get rid of unwanted personal experiences by avoiding or suppressing them. Timepoint: It takes two months before and after the study begins. Method of measurement: Cognitive avoidance is the score that the subject obtains from the Cognitive Avoidance Questionnaire, Sexton and Dagas (2004).</prim_outcome>
      <prim_outcome>Emotional capital is a state of inner positive emotional energy and vitality that can be directed and transformed, which, with purposeful focus, has the ability to have a relatively lasting impact on human behaviors and choices, and is capable of expanding individuals' capacities and skills, promoting mental health, and psychological well-being. Timepoint: It takes two months before and after the study begins. Method of measurement: Emotional capital is the score that the subject obtains from the Emotional Capital Questionnaire (Golparvar, 2016).</prim_outcome>
      <prim_outcome>Literally, metaemotion means awareness of emotion, and figuratively, it means organizing a group of thoughts, feelings, and emotions about emotions. Timepoint: It takes two months before and after the study begins. Method of measurement: Hyperemotion is the score that the subject obtains from the Hyperemotion Questionnaire, Mittmannsgruber et al. (2009).</prim_outcome>
      <prim_outcome>Social self-efficacy is the belief and expectation that an individual has about their ability to succeed in social situations and interpersonal behavior. Timepoint: It takes two months before and after the study begins. Method of measurement: Social self-efficacy is the score that the subject obtains from the Social Self-Efficacy Scale, Gaudiano and Herbert (2003).</prim_outcome>
      <prim_outcome>Mindfulness-based cognitive therapy allows a person to engage with negative thoughts and feelings in a nonjudgmental, accepting manner, rather than reacting automatically to them. This approach is particularly effective for treating depression, anxiety, and stress-related disorders, and focuses on enhancing present-moment awareness, accepting emotional experiences, and reducing psychological distress. Timepoint: It takes three months before and after the study begins. Method of measurement: The content of mindfulness-based cognitive therapy is introduced based on the educational protocol of Williams, Segal, and Tizdel (2002). This intervention is designed in the form of 8 90-minute sessions. It will be carried out on the experimental group during 8 90-minute sessions. In Iran, this protocol has been used by Mohammad Gholizadeh (2015; quoted from Mousavi et al., 2010).</prim_outcome>
      <prim_outcome>Anxiety is a type of worry about the future and negative events. It triggers intense mental-verbal activity. Virtual reality is a relatively new technology that enables people to immerse themselves in a virtual world. This method has many advantages, including a more or less real-life environment that allows patients to forget that they are being tested and provides the opportunity for them to participate better. Timepoint: It takes three months before and after the study begins. Method of measurement: In this study, virtual reality-based anxiety exposure therapy refers to therapy sessions that will be conducted on the experimental group over 8 45-minute sessions based on the protocol (North et al., 2015). Virtual reality in which the individual is confronted with anxiety-provoking scenes in socially fearful subjects.</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>solmaz choheili</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-01-23</approval_date>
        <contact_name>Islamic Azad University, Ahvaz</contact_name>
        <contact_address>No. 718, Khansari Street, Zand Street ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
