<?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>IRCT20260510069338N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-05-14</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Investigating the effectiveness of compassion-based therapy on internalized shame and social anxiety in female students</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Compassion-Based Therapy (CFT) on Internalized Shame and Social Anxiety in Female Students with Body Dysmorphic Disorder in  Azad University</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-05-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90013</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 all female students at different educational levels of Islamic Azad University, in the second semester of the 2025–2026 academic year who exhibit body dysmorphic symptoms. In this type of effectiveness study, a two-stage approach is typically used: in the sample selection stage, convenience sampling is employed. After selecting the sample to a size of 30 participants based on the study’s inclusion and exclusion criteria, the participants will be randomly assigned to two groups: Compassion-Based Couple Therapy (intervention group) and waiting list (control group). Randomization will be carried out using variable block randomization with block sizes of 4 and 6 by an independent statistician who is not involved in the implementation process. The random allocation list will be generated using the RAND function in Microsoft Excel and then placed in opaque, sealed, and numbered envelopes so that neither the researcher nor the participants will be aware of the allocation sequence (allocation concealment). The envelopes will be opened, and the assigned group will be revealed only at the time each participant enters the study. To ensure the equality of baseline variables, such as anxiety level and age, their distribution across the two groups will be examined during the statistical analysis phase.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Body Dysmorphic Disorder Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Compassion-Focused Therapy.  Session Duration: 60 minutes.Total Sessions: 8 sessions. Session Frequency: Twice per week.Therapeutic Tools Used.This intervention focuses on activating internal compassion resources and reducing self-criticism, incorporating guided therapeutic dialogue, mindfulness exercises, self-compassion imagery, soothing breathing techniques, and compassionate writing exercises.Summary of Session Content: Session 1: Introduction to the therapy, explanation of compassion and shame concepts, pre-test administration. Session 2: Identification of thoughts and behaviors associated with internalized shame and social anxiety. Session 3: Training in compassionate imagery and soothing breathing techniques. Session 4: Mindfulness practice and non-judgmental acceptance of emotions.    Session 5: Compassionate letter writing and strengthening self-compassion. Session 6: Examination of factors contributing to self-criticism and shame. Session 7: Training in coping strategies and relaxation techniques. Session 8: Conclusion, review of learned material, post-test administration, and scheduling of 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 failure to complete the research work and write the article, which is a requirement for publishing the data, I will publish the data after resolving the aforementioned issues.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefeh Shomalzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, 7th Street, Sadeghieh Alley</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6177944466</zip>
        <telephone>+98 61 3228 0798</telephone>
        <email>atefehshomalzadeh@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefeh Shomalzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, 7th Street, Sadeghieh Alley</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6177944466</zip>
        <telephone>+98 61 3228 0798</telephone>
        <email>atefehshomalzadeh@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Score above the cut-off point on the Body Dysmorphic Disorder Questionnaire
Girls aged 18 to 30
Being a student at Ahvaz Azad University.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F45.22</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Body Dysmorphic Disorder</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:Compassion-Focused Therapy.  Session Duration: 60 minutes.Total Sessions: 8 sessions. Session Frequency: Twice per week.Therapeutic Tools Used.This intervention focuses on activating internal compassion resources and reducing self-criticism, incorporating guided therapeutic dialogue, mindfulness exercises, self-compassion imagery, soothing breathing techniques, and compassionate writing exercises.Summary of Session Content: Session 1: Introduction to the therapy, explanation of compassion and shame concepts, pre-test administration. Session 2: Identification of thoughts and behaviors associated with internalized shame and social anxiety. Session 3: Training in compassionate imagery and soothing breathing techniques. Session 4: Mindfulness practice and non-judgmental acceptance of emotions.    Session 5: Compassionate letter writing and strengthening self-compassion. Session 6: Examination of factors contributing to self-criticism and shame. Session 7: Training in coping strategies and relaxation techniques. Session 8: Conclusion, review of learned material, post-test administration, and scheduling of 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>Internalized Shame. 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 was David R. Cook's (1987) Internalized Shame Scale.</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 measurement method will be the SPIN questionnaire by Kathleen Connor et al. (2000).</prim_outcome>
      <prim_outcome>Body dysmorphic disorder syndrome. 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 revised Yale-Brown Obsessive-Compulsive Scale for Body Dysmorphic Disorder by Katherine Phillips et al. (1997).</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>2026-04-11</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>
