<?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>IRCT20250829067041N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-08-31</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Studying the effectiveness of mindfulness-based stress reduction treatment on cognitive avoidance, social anxiety, and anxiety sensitivity of 6th grade female students with social anxiety</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effectiveness of mindfulness-based stress reduction treatment on cognitive avoidance, social anxiety, and anxiety sensitivity of 6th grade female students with social anxiety</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-09-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/85839</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The statistical population of the present study consists of sixth grade female students who are studying in the academic year 2025-2026 and have social anxiety. To select a sample to diagnose social anxiety in students, a cluster random sampling method will be used. First, two districts will be randomly selected from four education districts, and then five sixth grade girls' schools from each district, and in the next stage, two sixth graders will be selected from each school. Then, after the students complete the social anxiety inventory, those whose scores on this questionnaire were one standard deviation above the mean and in a clinical interview conducted by a clinical psychologist based on the diagnostic and statistical criteria for mental disorders, fifth edition, will be selected as students with social anxiety. Finally, randomly selected students whose social anxiety score on the social anxiety inventory was one standard deviation above the mean in the previous stage, will also show symptoms of social anxiety in the clinical interview. 40 of them will be selected to participate in the research by simple random selection (drawing lots). Then, these people will be assigned to the experimental and control groups by simple random selection (20 people in the experimental group and 20 people in the control group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Social anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mindfulness-Based Stress Reduction Therapy: In this method, with a psychological understanding, the mind-body medicine models of stress are integrated with findings related to how to cope with the challenges of modern life. Therefore, this program includes intensive mindfulness meditation training and participants are trained to apply what they have learned practically in relation to the problems of managing the challenges of daily life. In the present study, mindfulness-based stress reduction therapy sessions will be implemented based on the Kabat-Zinn protocol (2013) and will be implemented in an 8-week period with 90-minute sessions, one session per week for the experimental group. After forming the groups, the subjects will be given questionnaires to measure the variables as a pre-test and they will be assured that the answers they give will remain confidential. People in the experimental group participated in the training course for about a month, for the experimental group, the mindfulness-based stress reduction therapy intervention was considered in 8 90-minute sessions and two sessions per week. After completing the training period, the experimental group was re-assessed using questionnaires to measure variables as a post-test. Intervention 2: Control group: There will be no intervention for the control group. However, to prevent factors threatening the internal validity of the study, such as compensatory competition from the control group or demoralization, they will receive the intervention after data collection. After completing the training period, the control group will be re-assessed with questionnaires to measure the variables as a post-test.</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 Due to the fact that the research work has not been completed and also due to the fact that the article has not been written, which is one of the main conditions for publishing the data, publication will be initiated as soon as the aforementioned items are completed.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Ahleshakheh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 52, West Kashan Street, Saadi Alley, Golestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6138643849</zip>
        <telephone>+98 61 3333 3333</telephone>
        <email>fatemeh.ahleshakhe@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Ahleshakheh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 52, West Kashan Street, Saadi Alley, Golestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6138643849</zip>
        <telephone>+98 61 3333 3333</telephone>
        <email>fatemeh.ahleshakhe@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No serious physical illness
Having social anxiety disorder diagnosed by a clinical psychologist
Female students aged 11 to 12 years</inclusion_criteria>
      <agemin>11 years</agemin>
      <agemax>12 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Attending other psychotherapy sessions at least one month before the study</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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mindfulness-Based Stress Reduction Therapy: In this method, with a psychological understanding, the mind-body medicine models of stress are integrated with findings related to how to cope with the challenges of modern life. Therefore, this program includes intensive mindfulness meditation training and participants are trained to apply what they have learned practically in relation to the problems of managing the challenges of daily life. In the present study, mindfulness-based stress reduction therapy sessions will be implemented based on the Kabat-Zinn protocol (2013) and will be implemented in an 8-week period with 90-minute sessions, one session per week for the experimental group. After forming the groups, the subjects will be given questionnaires to measure the variables as a pre-test and they will be assured that the answers they give will remain confidential. People in the experimental group participated in the training course for about a month, for the experimental group, the mindfulness-based stress reduction therapy intervention was considered in 8 90-minute sessions and two sessions per week. After completing the training period, the experimental group was re-assessed using questionnaires to measure variables as a post-test.</i_keyword>
      <i_keyword>Control group: There will be no intervention for the control group. However, to prevent factors threatening the internal validity of the study, such as compensatory competition from the control group or demoralization, they will receive the intervention after data collection. After completing the training period, the control group will be re-assessed with questionnaires to measure the variables as a post-test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social Anxiety Disorder: Social anxiety disorder is an extreme or unusual fear of situations in which one's behavior or performance may be scrutinized or evaluated by others. In other words, social anxiety is characterized by a significant, persistent, and irrational fear of being observed or negatively evaluated by others, which is accompanied by physical and psychological symptoms of anxiety. A person with social anxiety disorder avoids fearful situations or endures these situations with great stress. In the present study, it is the score that the subject obtains from the Social Anxiety Inventory of Kanwar et al. (2000); standardized by Hassanvand Amuzadeh (2014). Timepoint: In this design, subjects are measured before the independent variable is implemented (pre-test), then the experimental intervention or independent variables are applied. After that, subjects are measured again. The structure of the therapy sessions was developed based on the Kabat-Zinn method (2013) and is implemented in 8 90-minute sessions, two sessions per week for 1 month. Method of measurement: The research tool will include the Social Anxiety Inventory of Kanver et al. (2000). Also, the research data analysis was performed using SPSS version 26 computer software. And the significance level in this study is considered to be P=0.5.</prim_outcome>
      <prim_outcome>Cognitive avoidance: Cognitive avoidance is a type of mental strategy based on which people change their thoughts. Each person makes hypotheses about themselves and their environment when dealing with a situation. These hypotheses are perfectionistic and biased criteria about social performance that can lead to the formation of physical and psychological symptoms. In other words, cognitive avoidance is one of the strategies that anxious people use to process information in anxiety-provoking environments and, through this, try to change their thoughts and mental images in order to free themselves from environmental concerns. In the present study, it is the score that the subject obtained from the cognitive avoidance questionnaire developed by Sexton and Dugas (2008), which was first translated in Iran by Basaknejad et al. (2010) and validated on a student population. Timepoint: In this design, subjects are measured before the independent variable is implemented (pre-test), then the experimental intervention or independent variables are applied. After that, subjects are measured again. The structure of the therapy sessions was developed based on the Kabat-Zinn method (2013) and is implemented in 8 90-minute sessions, two sessions per week for 1 month. Method of measurement: The research tool will include: Sexton and Dugas (2008) Cognitive Avoidance Questionnaire. Also, the research data analysis was done using SPSS version 26 computer software. And the significance level in this research is considered to be P=0.5.</prim_outcome>
      <prim_outcome>Anxiety sensitivity: Anxiety sensitivity is a cognitive component that indicates the fear of the appearance of anxiety symptoms. In other words, anxiety sensitivity causes the individual to believe that the signs and symptoms of anxiety are dangerous to the individual's health and can lead to bad results. On the other hand, in this anxiety, the individual fears that anxiety symptoms, such as increased heart rate and dizziness, will increase social, cognitive, and physical consequences in the individual and cause the individual harm. Anxiety sensitivity in this study refers to the score that the subject obtained on the Floyd et al. (2005) Anxiety Sensitivity Inventory. Timepoint: In this design, subjects are measured before the independent variable is implemented (pre-test), then the experimental intervention or independent variables are applied. After that, subjects are measured again. The structure of the therapy sessions was developed based on the Kabat-Zinn method (2013) and is implemented in 8 90-minute sessions, two sessions per week for 1 month. Method of measurement: The research tool will include: Floyd et al.'s Anxiety Sensitivity Index (2005). Also, the research data analysis was performed using SPSS version 26 computer software. The significance level in this study is considered to be P=0.5.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-08-20</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of Ahvaz Branch</contact_name>
        <contact_address>Opposite Keshavarz Street, Farhang Shahr, Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
