<?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>IRCT20251121068065N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-12</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>A comparative study of the effect of emotional schema therapy with cognitive behavioral therapy on quality of life, body image, resilience, and marital satisfaction in women with breast cancer who underwent mastectomy in 2015-2016</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the effect of emotional schema therapy with cognitive behavioral therapy on quality of life, body image, resilience, and marital satisfaction in women with breast cancer who underwent mastectomy in 2015-2016</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/89898</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Following sample selection, participants will be randomly assigned to the experimental and control groups.
In the first stage, after voluntary sample selection, all selected individuals are placed on a list (numbered 1 to 36).
In the second stage, among these individuals, using a random method with sealed, opaque, numbered envelopes, participants are divided into experimental and control groups.
Each individual randomly selects an envelope and is assigned to the relevant group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Women who have undergone mastectomy for breast cancer. Condition 2: Body image in women who have undergone mastectomy for breast cancer. Condition 3: Resilience in women who have undergone mastectomy for breast cancer. Condition 4: Marital satisfaction in women who have undergone mastectomy for breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Participants in this group will receive Cognitive Behavioral Therapy (CBT) over a specified period in 8 to 12 sessions. Intervention 2: Intervention group: Participants in this group will receive Emotional Schema Therapy over a specified period in 8 to 12 sessions.</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 available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gholamreza Talebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University Najafabad Branch, Daneshgah Blvd., Najafabad, Isfahan Province.</address>
        <city>Najafabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9514143131</zip>
        <telephone>+98 913 317 0681</telephone>
        <email>rezatalebi@iau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gholamreza Talebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University Najafabad Branch, Daneshgah Blvd., Najafabad, Isfahan Province.</address>
        <city>Najafabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8514143131</zip>
        <telephone>+98 913 317 0681</telephone>
        <email>rezatalebi@iau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women diagnosed with breast cancer who have undergone mastectomy
Participants aged between 18 and 65 years
Married or in a marital relationship
Psychologically prepared for individual and group therapy and willing to express their emotions and experiences</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Participants must not have severe mental disorders (such as personality disorders, severe depression, or psychotic disorders)
Participants must not be currently receiving similar treatments</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50</hc_code>
      <hc_code>C50</hc_code>
      <hc_code>C50</hc_code>
      <hc_code>C50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of breast</hc_keyword>
      <hc_keyword>Malignant neoplasm of breast</hc_keyword>
      <hc_keyword>Malignant neoplasm of breast</hc_keyword>
      <hc_keyword>Malignant neoplasm of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Participants in this group will receive Cognitive Behavioral Therapy (CBT) over a specified period in 8 to 12 sessions.</i_keyword>
      <i_keyword>Intervention group: Participants in this group will receive Emotional Schema Therapy over a specified period in 8 to 12 sessions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The participants’ quality of life will be assessed using standardized questionnaires. Timepoint: Assessments will be conducted before the start of the intervention and after the completion of the treatment sessions (8 to 12 sessions). Method of measurement: Quality of life before and after the treatment sessions will be measured using the World Health Organization Quality of Life questionnaire (WHOQOL) or the 36-Item Short Form Health Survey (SF-36).</prim_outcome>
      <prim_outcome>Body image will be assessed using questionnaires. Timepoint: Assessments will be conducted before the start of the intervention and after the completion of the treatment sessions (8 to 12 sessions). Method of measurement: Instruments such as the Body Image Scale (BIS) or a body image questionnaire for cancer patients will be used.</prim_outcome>
      <prim_outcome>The participants’ level of resilience will be evaluated. Timepoint: Assessments will be conducted before the start of the intervention and after the completion of the treatment sessions (8 to 12 sessions). Method of measurement: The Connor-Davidson Resilience Scale (CD-RISC) will be used.</prim_outcome>
      <prim_outcome>Marital satisfaction will be examined. Timepoint: Assessments will be conducted before the start of the intervention and after the completion of the treatment sessions (8 to 12 sessions). Method of measurement: To evaluate marital satisfaction, the ENRICH Marital Satisfaction Questionnaire or the Dyadic Adjustment Scale (DAS) will be used.</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>2025-12-11</approval_date>
        <contact_name>Research Ethics Committee of Islamic Azad University-Najafabad Branch</contact_name>
        <contact_address>Islamic Azad University Najafabad Branch, Daneshgah Blvd., Najafabad, Isfahan Province. Najafabad Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
