<?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>IRCT20190118042403N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-20</date_registration>
      <primary_sponsor>Islamic Azad University Of Khorasgan</primary_sponsor>
      <public_title>The effect of compassion focused therapy on perceived stress, body image anxiety, valuing body and psychological distress.</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of compassion-focused therapy on perceived stress, body image anxiety, valuing body and psychological distress in the women suffering from breast cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36935</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 30 patients with breast cancer were selected based on the inclusion and exclusion criteria. Through a Simple randomization method, 15 people were assigned to the intervention group and 15 were assigned to the control group using the random numbers table. In the use of random numbers table, first, how to read the numbers in the table were determined. Then the even numbers for the intervention group and the odd numbers for the control group were considered.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group-Based Compassion-Focused Therapy was used for treatment in the intervention group. The treatment group performed a 90 minute session per week. The number of sessions according to the protocol was considered 8 sessions. Compassion-focused therapy  aims to help promote mental and emotional healing by encouraging  patients in treatment to be compassionate toward themselves and other people. Compassion, both toward the self and toward others, is an emotional response believed by many to be an essential aspect of well-being. The mentioned treatment goals were implemented in accordance with the protocol. Regarding the disease, participants received routine medical treatments for breast cancer. Intervention 2: Control group: Routine therapies for breast cancer.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Razieh Porhoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>East Gey Street., Arghavanieh., University Blvd</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8155139998</zip>
        <telephone>+98 31 3535 4001</telephone>
        <email>m.porhoseini1361@gmail.com</email>
        <affiliation>Islamic Azad University Of Khorasgan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Razieh Porhoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>East Gey Street., Arghavanieh., University Blvd</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8155139998</zip>
        <telephone>+98 31 3535 4001</telephone>
        <email>m.porhoseini1361@gmail.com</email>
        <affiliation>Islamic Azad University Of Khorasgan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a breast cancer disease by diagnosing an oncologist
From 20 years old to 60 years old
Have at least a diploma degree
Having a physical and cognitive ability to participate in the study
Not having another psychotherapy record
Informed consent and willingness to participate in research</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having psychiatric disorders (based on DSM-5)
Advanced cancer disease
Affected by a variety of other cancers</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>c50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group-Based Compassion-Focused Therapy was used for treatment in the intervention group. The treatment group performed a 90 minute session per week. The number of sessions according to the protocol was considered 8 sessions. Compassion-focused therapy  aims to help promote mental and emotional healing by encouraging  patients in treatment to be compassionate toward themselves and other people. Compassion, both toward the self and toward others, is an emotional response believed by many to be an essential aspect of well-being. The mentioned treatment goals were implemented in accordance with the protocol. Regarding the disease, participants received routine medical treatments for breast cancer.</i_keyword>
      <i_keyword>Control group: Routine therapies for breast cancer</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived Stress Score in Perceived Stress Questionnaire. Timepoint: Perceived stress questionnaire before intervention, after intervention and 45 days after intervention. Method of measurement: perceived stress questionnaire.</prim_outcome>
      <prim_outcome>Psychological Distress Score in Psychological Distress Questionnaire. Timepoint: Psychological Distress questionnaire before intervention, after intervention and 45 days after intervention. Method of measurement: psychological distress questionnaire.</prim_outcome>
      <prim_outcome>Body Image Anxiety Score in Body Image Anxiety Questionnaire. Timepoint: Body Image Anxiety questionnaire before intervention, after intervention and 45 days after intervention. Method of measurement: Body Image Anxiety questionnaire.</prim_outcome>
      <prim_outcome>Valuing Body. Timepoint: Valuing Body questionnaire before intervention, after intervention and 45 days after intervention. Method of measurement: Valuing Body questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Therapeutic alliance. Timepoint: after intervention on experimental group. Method of measurement: Working Alliance Inventory-Short Revised (WAI-SR).</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 Of Khorasgan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-24</approval_date>
        <contact_name>Ethics committee of Islamic Azad University Of Khorasgan</contact_name>
        <contact_address>East Gey Street ., Arghavanieh., University Blvd Isfehan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
