<?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>IRCT20260715070197N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-28</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effectiveness of a Mindfulness-Based Stress Reduction Program on Anxiety Sensitivity and Fear of Negative Evaluation in Non-Athlete Adolescent Girls with Symptoms of Social Anxiety Disorder</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of a Mindfulness-Based Stress Reduction (MBSR) Program on Anxiety Sensitivity and Fear of Negative Evaluation in Non-Athlete Adolescent Girls with Symptoms of Social Anxiety Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/92838</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After initial assessment and confirmation of eligibility, participants will be randomly assigned to intervention and control groups using variable block randomization with a 1:1 allocation ratio. The unit of randomization is individual. To enhance group homogeneity, stratified randomization will be performed based on age and symptom severity. The randomization sequence will be generated using statistical software and concealed in opaque, numbered envelopes, Blinding description: In this study, due to the nature of the intervention (group-based mindfulness training sessions), it is not possible to blind the participants and the therapist. Therefore, only the outcome assessor and the data analyst will be blinded to group allocation. The outcome assessor, who is responsible for data collection and administering the questionnaires at pre-test and post-test stages, will be unaware of the participants' group assignments and will work only with individual codes. Additionally, the data analyst will receive the data without knowledge of group allocation, and the decoding of groups will be performed only after the final analysis is completed. The principal investigator, therapist, and participants are aware of the group allocation, and this has been explained to the participants during the informed consent process.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Social Anxiety Disorder.</hc_freetext>
      <i_freetext>Intervention group: The intervention consists of a Mindfulness-Based Stress Reduction program delivered in 8 sessions of 90 minutes each (one session per week) in a group format. Session content includes training in progressive muscle relaxation, mindfulness of breathing, body scan, mindfulness of thoughts, and meditation exercises. The control group is placed on a waiting list and receives no intervention. Between-session assignments are provided to reinforce skill consolidation..</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 No further information is available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeynab Khatibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nikan Counseling Center, Nooshin Complex, West 9th Boulevard, Kianpars, Ahvaz, Iran.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3733361349</zip>
        <telephone>+98 61 3334 8420</telephone>
        <email>r.fati.r2020@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zeynab Khatibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nikan Counseling Center, Nooshin Complex, West 9th Boulevard, Kianpars, Ahvaz, Iran.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3733361349</zip>
        <telephone>+98 61 3334 8420</telephone>
        <email>r.fati.r2020@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of symptoms of social anxiety disorder based on DSM-5 criteria and confirmed by a clinical psychologist or psychiatrist.
Female gender and age range of 13 to 18 years.
No participation in regular, organized sports programs (non-athlete status) in the past 6 months.
Written informed consent from parents or legal guardians, along with verbal assent from the adolescent to participate in the study.</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Diagnosis of other acute or severe psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depressive disorder with psychotic symptoms, or severe eating disorders).
Simultaneous participation in other therapeutic programs or psychological interventions for social anxiety.</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>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention consists of a Mindfulness-Based Stress Reduction program delivered in 8 sessions of 90 minutes each (one session per week) in a group format. Session content includes training in progressive muscle relaxation, mindfulness of breathing, body scan, mindfulness of thoughts, and meditation exercises. The control group is placed on a waiting list and receives no intervention. Between-session assignments are provided to reinforce skill consolidation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety Sensitivity. Timepoint: Pre-test and Post-test. Method of measurement: The Anxiety Sensitivity Index (ASI) is a self-report questionnaire consisting of 16 items. It was developed by Reiss and Peterson in 1985. The questionnaire comprises three factors: fear of physical concerns (8 items), fear of cognitive dyscontrol (4 items), and fear of publicly observable anxiety symptoms (4 items).</prim_outcome>
      <prim_outcome>Fear of Negative Evaluation. Timepoint: Pre-test and Post-test. Method of measurement: This questionnaire, whose short form was developed by Leary in 1983, was designed to measure the fear of negative evaluation. The brief version (FNES-B) consists of 12 items, rated on a 5-point Likert scale. This instrument has demonstrated good validity and reliability.</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>2026-08-23</approval_date>
        <contact_name>Research Ethics Committee of Islamic Azad University, Ahvaz Branch.</contact_name>
        <contact_address>Islamic Azad University, Ahvaz Branch, 22 Bahman Boulevard, Ahvaz, Iran. Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
