<?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>IRCT20210407050888N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-17</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of compassion on bulimia nervosa</public_title>
      <acronym>پرخوری عصبی</acronym>
      <scientific_title>The effectiveness of compassion focused therapy on reducing feelings of guilt, shame, self criticism, psychological distress and social isolation in people with eating disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65665</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this research, simple individual randomization method will be used. In this way, the identified people with bulimia nervosa disorder will be organized into two groups of 15 people (experimental and control) by simple randomization method. A table of random numbers will be used for randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>bulimia nervosa disorder.</hc_freetext>
      <i_freetext>Intervention 1: There is two months for Compassion-focused therapy training. One session in every week and a total of eight sessions. For each sessions will explain  about the disorder, characteristics, intervening factors, examination Physiological effects of hormones, coping methods, mindfulness, training related to treatment focused on compassion that is appropriate and in accordance with the protocol of this type of treatment. Safety strategies, concentration, correct breathing, yoga, compassionate letter, Mantra and mindfulness eating will be experienced .At the beginning, the bulimia nervosa diagnostic tool is used to ensure the existence of this disorder. After identifying the existence of this disorder, thirty people will considered for the research work and from this number, two groups of fifteen people were randomly separated with the names of the control group and the experimental group. At this stage, both groups will be given consent forms and personal information, so that after completing it, they will enter the stage of the tests. A single pre-test is used for both groups, with the difference that the test sheets of the control group with a letterhead (PRE.T.CO) means the pre-test or pre-test of the control group, and the papers of the subject group with a letterhead (PRE.T.A) ) means pre-test or pre-test of the subject group. This apparent separation is to compare the answers given by each person at the end of the research and has no other reason. After the end of the eighth session, the same test was again given to the same people who were in the control group, but this time with the post-test with a sheet of paper (POST.T.CO) and to the same people of the first subject group, the same test but this time. It is given with the header (POST.T.A) which means post-test and after that it will be time to check and analyze the data. Intervention 2: Control group: we haven't any intervention for this group and only pretest and post-test is used for them.</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 not more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Ali Akbar Karimi AH</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University - Sari Mazandaran Province, Farah Abad Rd, Iran</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816119318</zip>
        <telephone>۰۱۱۳۳۰۳۲۸۹۱ ,۰۱۱۳۳۱۷۵۳۳۳</telephone>
        <email>aliakbarkarimiah@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Ali Akbar Karimi Ah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University - Sari Mazandaran Province, Farah Abad Rd, Iran</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816119318</zip>
        <telephone>۰۱۱۳۳۰۳۲۸۹۱ ,۰۱۱۳۳۱۷۵۳۳۳</telephone>
        <email>Aliakbarkarimiah@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Bulimia nervosa disorder
sex: female
Age : 18-40
Having informed consent  of participate in this research.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>hyper activity or hypo activity in thyroid
pregnancy
drug and alcohol abuse
inability to perform intervention tasks
overweight treatment of drug</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>There is two months for Compassion-focused therapy training. One session in every week and a total of eight sessions. For each sessions will explain  about the disorder, characteristics, intervening factors, examination Physiological effects of hormones, coping methods, mindfulness, training related to treatment focused on compassion that is appropriate and in accordance with the protocol of this type of treatment. Safety strategies, concentration, correct breathing, yoga, compassionate letter, Mantra and mindfulness eating will be experienced .At the beginning, the bulimia nervosa diagnostic tool is used to ensure the existence of this disorder. After identifying the existence of this disorder, thirty people will considered for the research work and from this number, two groups of fifteen people were randomly separated with the names of the control group and the experimental group. At this stage, both groups will be given consent forms and personal information, so that after completing it, they will enter the stage of the tests. A single pre-test is used for both groups, with the difference that the test sheets of the control group with a letterhead (PRE.T.CO) means the pre-test or pre-test of the control group, and the papers of the subject group with a letterhead (PRE.T.A) ) means pre-test or pre-test of the subject group. This apparent separation is to compare the answers given by each person at the end of the research and has no other reason. After the end of the eighth session, the same test was again given to the same people who were in the control group, but this time with the post-test with a sheet of paper (POST.T.CO) and to the same people of the first subject group, the same test but this time. It is given with the header (POST.T.A) which means post-test and after that it will be time to check and analyze the data.</i_keyword>
      <i_keyword>Control group: we haven't any intervention for this group and only pretest and post-test is used for them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The main variable in this trial  is Bulimia nervosa that Eligible people to enter the research by participating in the test The Eating Attitudes Test (EAT-26) will be identified. Timepoint: Two months. Method of measurement: The Self-Compassion Scale Short Form (SCS-SF; Raes et al., 2011) with 26 items.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Bulimia nervosa,. Timepoint: Two months. Method of measurement: The Eating Attitudes Test (EAT-26) is used to identify the presence of “eating disorder  with 26 items.</sec_outcome>
      <sec_outcome>Feelings of guilt. Timepoint: Two months. Method of measurement: For this variable Guilt and Shame Proneness Scale (GASP) 2011 Cohen, T. R., Wolf, S. T., Panter, A. T., &amp; Insko, C. A. whit 16 items is used.</sec_outcome>
      <sec_outcome>Shame. Timepoint: Two months. Method of measurement: For this variable Guilt and Shame Proneness Scale (GASP) 2011 Cohen, T. R., Wolf, S. T., Panter, A. T., &amp; Insko, C. A. whit 16 items is used.</sec_outcome>
      <sec_outcome>Self criticism. Timepoint: Two months. Method of measurement: Exploring self-criticism — The Levels of Self-criticism Scale Thompson &amp; Zuroff, 2004 is a 22-item self-report.</sec_outcome>
      <sec_outcome>Psychological distress. Timepoint: Two months. Method of measurement: For this variable Depression Anxiety and Stress Scale 21 (DASS-21) whit 21 items is used.</sec_outcome>
      <sec_outcome>Social isolation. Timepoint: Two months. Method of measurement: For this variable, to measure one's subjective feelings of loneliness as well as feelings of social isolation(Russell, Peplau &amp; Cutrona) with 20 items is used.</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 - Sari Mazandaran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-10</approval_date>
        <contact_name>Islamic Azad University -Sari Branch</contact_name>
        <contact_address>Azad university -seventh kilometer- daria Blvd Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
