<?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>IRCT20161228031626N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-31</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation effectiveness of compassion-focused therapy on shame and self-criticism in patients with psychotic disorder</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation effectiveness of compassion-focused therapy on shame and self-criticism in patients with a psychotic disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60536</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to divide patients into two groups, the randomized block method is used. In this method, group A is related to the intervention and group B is considered as the control and is classified into 4 blocks including AABB, ABAB, ABBA, BBAA, BABA, BAAB, according to the selected permutations. The patient is classified into one of the intervention or control groups. Random allocation software was used for randomization.</study_design>
      <phase>2-3</phase>
      <hc_freetext>psychotic disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After the patients are selected, based on the treatment group, the patients are treated with compassion-focused treatment and after the treatment, the information is re-evaluated. The compassion-focused treatment protocol will be implemented in accordance with the content of the treatment in 10 sessions. The basic principles of compassion-focused therapy point out that external soothing thoughts, factors, images, and behaviors must be internalized, and in this case, the human mind, as it responds to external factors, in the face of this Relax inside. Sessions 1 and 2: Evaluation based on compassion-focused treatment approach, Session 3: Understanding compassion, Session 4: Preparing clients to improve compassionate attention and concentration, Session 5: Illustration of daily compassion, Session 6: Examining the role of self-criticism and shame using the metaphor of two teachers, introducing compassionate self, Session 7: Introducing multiple selves references, exercising multiple selves, Session 8: Compassionate thinking and argument and compassionate behavior, Session 9: Balancing thinking and mind in a compassionate way, Session 10: Writing a letter of compassion. Intervention 2: Control group: After the patients are selected, the patients are treated normally based on the group therapy and the information is re-evaluated after the treatment.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hatam Boostani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Golestan Hospital,Golestan Blvd, Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>157945-6135</zip>
        <telephone>+98 61 3374 3038</telephone>
        <email>Boostani_h@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hatam Boostani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Golestan Hospital,Golestan Blvd, Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>157945-6135</zip>
        <telephone>+98 61 3374 3038</telephone>
        <email>Boostani_h@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with psychotic disorder</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of other mental illness disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F23</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Brief psychotic 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: After the patients are selected, based on the treatment group, the patients are treated with compassion-focused treatment and after the treatment, the information is re-evaluated. The compassion-focused treatment protocol will be implemented in accordance with the content of the treatment in 10 sessions. The basic principles of compassion-focused therapy point out that external soothing thoughts, factors, images, and behaviors must be internalized, and in this case, the human mind, as it responds to external factors, in the face of this Relax inside. Sessions 1 and 2: Evaluation based on compassion-focused treatment approach, Session 3: Understanding compassion, Session 4: Preparing clients to improve compassionate attention and concentration, Session 5: Illustration of daily compassion, Session 6: Examining the role of self-criticism and shame using the metaphor of two teachers, introducing compassionate self, Session 7: Introducing multiple selves references, exercising multiple selves, Session 8: Compassionate thinking and argument and compassionate behavior, Session 9: Balancing thinking and mind in a compassionate way, Session 10: Writing a letter of compassion</i_keyword>
      <i_keyword>Control group: After the patients are selected, the patients are treated normally based on the group therapy and the information is re-evaluated after the treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Shame. Timepoint: Before and after intervention. Method of measurement: Self-Compassion Scale (SCS questioner).</prim_outcome>
      <prim_outcome>Self-criticism. Timepoint: Before and after intervention. Method of measurement: Self-Compassion Scale (SCS questioner).</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-22</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundishapur University of  of Medical Sciences</contact_name>
        <contact_address>Ahvaz Golestan Hospital ,Golestan Blvd, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
