<?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>IRCT20260511069341N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-05-12</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of mindfulness training based on stress reduction on emotional components of students with social anxiety symptoms</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Mindfulness Training Based on Stress (MBSR) Reduction on Reducing Arousal Levels, Anxiety Sensitivity, and Anger Suppression in Students with Symptoms of Social Anxiety Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-05-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90025</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 this study includes all female and male students at various academic levels of Islamic Azad University in the 2025–2026 academic year who exhibit symptoms of social anxiety disorder (i.e., score below the cutoff on the SIAS scale). In this type of efficacy study, a two-stage approach is usually used: in the sample selection stage, convenience sampling is employed. After selecting a sample of 40 participants, and based on the study’s inclusion and exclusion criteria, the participants will be randomly assigned to two groups: the “Mindfulness-Based Stress Reduction” group (intervention group) and the “waiting list” group (control group). Randomization will be performed using random blocks with variable sizes (4 and 6 participants) by an independent statistician who is not involved in the implementation process. The random allocation list will be generated using the RAND function in Excel and then placed in opaque, sealed, and numbered envelopes so that neither the researcher nor the participants are aware of the allocation sequence (allocation concealment). Opening the envelope and informing the participant of the assigned group will take place only when each participant enters the study. To ensure the equivalence of baseline variables (such as anxiety level and age), their distribution in the two groups will be examined in the statistical analysis stage.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Social Anxiety Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mindfulness-Based Stress Reduction (MBSR) training.Duration of each session: 90 minutes; Total number of sessions: 8 sessions; Session sequence: twice a week.Therapeutic tools used:This intervention relies on cultivating moment-to-moment awareness, intentional attention, acceptance of inner experiences, and reducing reactivity to unpleasant thoughts and emotions. The main therapeutic tools include mindfulness exercises, body scan, sitting meditation, mindful breathing practice, gentle yoga movements, and present-moment attention exercises.The content of the different sessions is based on the following:Session 1: Administration of the pre-test, introduction of group members, introduction to mindfulness, and familiarization with the goals and structure of the program.Session 2: Training in attention to breathing and body scan practice.Session 3: Continuation of the body scan and practice of bringing attention back to the present moment.Session 4: Training in sitting meditation and accepting thoughts and feelings without judgment.Session 5: Practice of gentle mindful movements and simple yoga.Session 6: Training in mindful exposure to stress and observing thoughts and emotions.Session 7: Review and consolidation of the learned skills and practice of applying them in daily life.Session 8: Summary, feedback collection, administration of the post-test, and scheduling the follow-up assessment. Intervention 2: Control group:The control group will not receive any intervention during the research, but will receive the intervention after data collection to prevent factors that threaten the internal validity of the research, such as compensatory competition from the control group or demoralization.</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 incomplete status of the research work and the failure to prepare the manuscript, which is a prerequisite for data publication, I will proceed with the publication of the data as soon as the aforementioned issues are resolve</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa Kamaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 16, 4th Floor, Makhzan Saz Asli, corner of Fajr St., Nasih Blvd. West, Sad Dastgah</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6176944715</zip>
        <telephone>+98 61 3333 3333</telephone>
        <email>parisa.kamaei@iau.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parisa Kamaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 16, 4th Floor, Makhzan Saz Asli, corner of Fajr St., Nasih Blvd. West, Sad Dastgah</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6176944715</zip>
        <telephone>+98 61 3333 3333</telephone>
        <email>parisa.kamaei@iau.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being a student in one of the academic programs of the studied university
Having symptoms of social anxiety disorder based on a clinical interview or a high score on the relevant standardized questionnaire
Age range 18 to 24 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>24 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in research
Simultaneous participation in similar psychological or pharmacological courses</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40.11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Social phobia, generalized</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 (MBSR) training.Duration of each session: 90 minutes; Total number of sessions: 8 sessions; Session sequence: twice a week.Therapeutic tools used:This intervention relies on cultivating moment-to-moment awareness, intentional attention, acceptance of inner experiences, and reducing reactivity to unpleasant thoughts and emotions. The main therapeutic tools include mindfulness exercises, body scan, sitting meditation, mindful breathing practice, gentle yoga movements, and present-moment attention exercises.The content of the different sessions is based on the following:Session 1: Administration of the pre-test, introduction of group members, introduction to mindfulness, and familiarization with the goals and structure of the program.Session 2: Training in attention to breathing and body scan practice.Session 3: Continuation of the body scan and practice of bringing attention back to the present moment.Session 4: Training in sitting meditation and accepting thoughts and feelings without judgment.Session 5: Practice of gentle mindful movements and simple yoga.Session 6: Training in mindful exposure to stress and observing thoughts and emotions.Session 7: Review and consolidation of the learned skills and practice of applying them in daily life.Session 8: Summary, feedback collection, administration of the post-test, and scheduling the follow-up assessment.</i_keyword>
      <i_keyword>Control group:The control group will not receive any intervention during the research, but will receive the intervention after data collection to prevent factors that threaten the internal validity of the research, such as compensatory competition from the control group or demoralization.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Arousal. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: The measurement method will be the Henry and Crawford (2005) Physiological Arousal Scale.</prim_outcome>
      <prim_outcome>Anxiety Sensitivity. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: The measurement method will be the Anxiety Sensitivity Index-3 of Taylor and Cox (1998).</prim_outcome>
      <prim_outcome>Anger. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: The method of measurement will be the Spielberger (1999) trait-state anger expression questionnaire.</prim_outcome>
      <prim_outcome>Social Anxiety. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: The method of measurement will be the Jerabek Social Anxiety Questionnaire (1996).</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>2026-04-15</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>
