<?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>IRCT20250421065429N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-24</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effect of Group Cognitive-Behavioral Counseling on Reducing Stress, Increasing Uncertainty Tolerance, and Reducing Negative Repetitive Thoughts in University Students with Social Anxiety</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the Effectiveness of Cognitive-Behavioral Therapy (CBT) on Perceived Stress, Intolerance of Uncertainty, and Mental Rumination in University Students with Social Anxiety Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/90540</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After screening students using the Social Anxiety Questionnaire among undergraduate and graduate students of Islamic Azad University, Sari Branch (11,274 students) between 2025/04/20 and 2025/06/09, 30 students who obtained the highest scores in social anxiety and met the inclusion criteria were selected. These participants were then assigned to two groups, an experimental group (15 participants) and a control group (15 participants), using a simple randomization method with the help of statistical software.
The unit of randomization was the individual participant. To reduce selection bias, the selected participants were first coded and then allocated to the two groups according to a randomly generated sequence.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Social Anxiety (Social Phobia) in University Students.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group Cognitive-Behavioral Therapy based on the standard and specific protocol for Social Anxiety Disorder (Social Phobia), consisting of 12 sessions of 90 minutes each, delivered in a group format (each group consisting of 8 to 12 participants). Sessions are held weekly for 12 consecutive weeks.Content of treatment sessions includes:    Sessions 1 to 3 (Introduction and Psychoeducation): Familiarization of members with each other, establishing therapeutic alliance, teaching the cognitive-behavioral model of social anxiety, identifying and recording negative automatic thoughts in social situations    Sessions 4 to 6 (Cognitive Restructuring): Teaching the identification of cognitive errors (such as catastrophizing, overgeneralization, mind reading), challenging maladaptive beliefs related to negative evaluation by others, replacing negative thoughts with balanced and realistic thoughts    Sessions 7 to 10 (Social Skills Training and Exposure): Teaching effective communication skills (initiating and maintaining conversation, assertiveness, active listening), gradual in-session exposure to feared social situations (such as public speaking, talking to strangers, expressing opinions in groups), and practicing deep breathing and progressive muscle relaxation to manage physiological symptoms of anxiety    Sessions 11 to 12 (Consolidation and Relapse Prevention): Review of learned skills, planning for independent exposure in natural environments, identifying signs of relapse risk, and developing strategies to prevent symptom recurrenceNumber of sessions: 12 sessionsDuration of each session: 90 minutesFrequency: One session per weekTotal intervention duration: 12 weeksMethod of delivery: Group-based (8 to 12 participants per group) and in-person. Intervention 2: Control group: The control group is placed on a waiting list and receives no psychological or pharmacological intervention during the study period. Participants in this group are assessed at the same time points as the intervention group (pre-test, post-test, and follow-up). After the completion of the treatment period for the intervention group and the post-test and follow-up assessments, the same cognitive-behavioral therapy program will be offered free of charge to the control group members if they wish.</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 Lack of participant consent</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Foolad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ایران، آمل، خیابان جاده قدیم آمل به بابل، نرسیده به روستای کمدره، دانشگاه آزاد اسلامی واحد آیت اله آملی</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815985834</zip>
        <telephone>+98 11 4321 7035</telephone>
        <email>dr.maryam.foolad@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Foolad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ایران، آمل، خیابان جاده قدیم آمل به بابل، نرسیده به روستای کمدره، دانشگاه آزاد اسلامی واحد آیت اله آملی</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815985834</zip>
        <telephone>+98 11 4321 7035</telephone>
        <email>dr.maryam.foolad@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Students aged 20-40 years from Islamic Azad University, Sari Branch
Score ≥ 19 on the Social Phobia Inventory (SPIN)
Having at least a high school diploma (ability to read and write)
Providing written informed consent to participate in the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Comorbid acute psychiatric disorders (e.g., major depressive disorder, bipolar disorder, psychotic disorder, or substance use disorder)
Concurrent receipt of any other psychological treatment
History of seizures, epilepsy, or neurological diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P05.08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Newborn light for gestational age, 2000-2499 grams</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group Cognitive-Behavioral Therapy based on the standard and specific protocol for Social Anxiety Disorder (Social Phobia), consisting of 12 sessions of 90 minutes each, delivered in a group format (each group consisting of 8 to 12 participants). Sessions are held weekly for 12 consecutive weeks.Content of treatment sessions includes:    Sessions 1 to 3 (Introduction and Psychoeducation): Familiarization of members with each other, establishing therapeutic alliance, teaching the cognitive-behavioral model of social anxiety, identifying and recording negative automatic thoughts in social situations    Sessions 4 to 6 (Cognitive Restructuring): Teaching the identification of cognitive errors (such as catastrophizing, overgeneralization, mind reading), challenging maladaptive beliefs related to negative evaluation by others, replacing negative thoughts with balanced and realistic thoughts    Sessions 7 to 10 (Social Skills Training and Exposure): Teaching effective communication skills (initiating and maintaining conversation, assertiveness, active listening), gradual in-session exposure to feared social situations (such as public speaking, talking to strangers, expressing opinions in groups), and practicing deep breathing and progressive muscle relaxation to manage physiological symptoms of anxiety    Sessions 11 to 12 (Consolidation and Relapse Prevention): Review of learned skills, planning for independent exposure in natural environments, identifying signs of relapse risk, and developing strategies to prevent symptom recurrenceNumber of sessions: 12 sessionsDuration of each session: 90 minutesFrequency: One session per weekTotal intervention duration: 12 weeksMethod of delivery: Group-based (8 to 12 participants per group) and in-person</i_keyword>
      <i_keyword>Control group: The control group is placed on a waiting list and receives no psychological or pharmacological intervention during the study period. Participants in this group are assessed at the same time points as the intervention group (pre-test, post-test, and follow-up). After the completion of the treatment period for the intervention group and the post-test and follow-up assessments, the same cognitive-behavioral therapy program will be offered free of charge to the control group members if they wish.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived Stress Score. Timepoint: Pre-test (Baseline): Measurement of perceived stress score using the Perceived Stress Scale (PSS-14), one week before the start of the intervention (first treatment session)    Post-test (Immediately after intervention): Measurement of perceived stress score using the Perceived Stress Scale (PSS-14), immediately after the completion of the last treatment session (twelfth session)    Follow-up (2 months): Measurement of perceived stress score using the Perceived Stress Scale (PSS-14), 2 months after the completion of the last treatment session. Method of measurement: The Perceived Stress Scale with 14 items (PSS-14). This questionnaire is completed by participants as a self-report measure. Each item is scored on a 5-point Likert scale (ranging from 0 = never to 4 = always). The total score ranges from 0 to 56.</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>2026-06-22</approval_date>
        <contact_name>دانشگاه آزاد اسلامی واحد آیت اله آملی</contact_name>
        <contact_address>Islamic Azad University, Ayatollah Amoli Branch, Daneshgah Street, Amol–Babol Road, before Komdereh Village, Amol, Iran. Amol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
