<?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>IRCT20230125057220N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-30</date_registration>
      <primary_sponsor>personal</primary_sponsor>
      <public_title>The comparison of effectiveness of emotion-focused therapy, self- compassion-focused therapy and physical exercise (yoga)  in women with Binge Eating Disorder</public_title>
      <acronym>EFT-CFT-BED</acronym>
      <scientific_title>The comparison of effectiveness of emotion-focused therapy, self- compassion-focused therapy and physical exercise (yoga) on experience of shame, self-esteem, attachment styles and self-efficacy in women with Binge Eating Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68219</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: available sampling method,
Simple randomization: each individual was given 4 sealed envelopes in the number of groups (3 experimental groups and one control group), and based on the choice of an envelope by the individual, his/her placement in a group is done.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Binge Eating Disorder.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: 10 sessions of focused emotional therapy. Intervention 2: Intervention group 2: 10 weeks and 3 sessions per week (30 sessions in total) yoga training. Intervention 3: Intervention group 3: 10 sessions of self-compassion therapy. Intervention 4: Control group:.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
all data

When:
six month after printing

To whom:
researchers

Conditions:
For the purpose of scientific research

Where to obtain:
Sites - University

How to obtain:
online search

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>maryam sarooghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yadgar Imam St. Nawab Square , Borujerd</address>
        <city>Borujerd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6915136111</zip>
        <telephone>+98 66 4251 8000</telephone>
        <email>m.srooghi@gmail.com</email>
        <affiliation>Islamic Azad university Brojerd</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Sarooghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hakimiyeh-Bahar BLV-behesht ST-behesh7 vallay- no7</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1659749783</zip>
        <telephone>+98 21 7700 8192</telephone>
        <email>m.srooghi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Informed consent to participate in research
with Binge Eating Disorder based on DSM-5
Diagnosing binge eating disorder (BED) of the subject based on the binge eating scale (cut point 16 and above)
Lack of drug treatment for weight loss before the research
No abuse of tobacco, drugs and cigarettes</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Taking psychiatric and psychoactive drugs
Absence of more than 2 sessions in treatment sessions
Simultaneous participation in other courses and therapeutic interventions at the same time as research
Having psychiatric disorders based on the person's self-report
drug abuse and smoking</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F50.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Bulimia nervosa</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: 10 sessions of focused emotional therapy</i_keyword>
      <i_keyword>Intervention group 2: 10 weeks and 3 sessions per week (30 sessions in total) yoga training</i_keyword>
      <i_keyword>Intervention group 3: 10 sessions of self-compassion therapy</i_keyword>
      <i_keyword>Control group:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Internal shame score. Timepoint: Before the start of the intervention (pre-intervention) - after the last session of the intervention (post-test) - 2 months later (follow-up). Method of measurement: Cook's Internal Shame Scale (ISS).</prim_outcome>
      <prim_outcome>External Shame Scale. Timepoint: Before the start of the intervention (pre-intervention) - after the last session of the intervention (post-test) - 2 months later (follow-up). Method of measurement: External Shame Scale (OAS) Goss et al.</prim_outcome>
      <prim_outcome>Self-esteem score. Timepoint: Before the start of the intervention (pre-intervention) - after the last session of the intervention (post-test) - 2 months later (follow-up). Method of measurement: Self-esteem (RSEs) Rosenberg.</prim_outcome>
      <prim_outcome>Adult attachment styles score. Timepoint: Before the start of the intervention (pre-intervention) - after the last session of the intervention (post-test) - 2 months later (follow-up). Method of measurement: Collins and Reed scale of adult attachment styles.</prim_outcome>
      <prim_outcome>Self-efficacy score. Timepoint: Before the start of the intervention (pre-intervention) - after the last session of the intervention (post-test) - 2 months later (follow-up). Method of measurement: Lifestyle self-efficacy questionnaire on weight (WELSQ).</prim_outcome>
      <prim_outcome>BED binge eating disorder score. Timepoint: Before the start of the intervention (pre-intervention) - after the last session of the intervention (post-test) - 2 months later (follow-up). Method of measurement: Binge Eating Severity Scale (BES) Gomali et al.</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>personal</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-14</approval_date>
        <contact_name>Ethics committee in research of Islamic Azad University, Borujerd branch</contact_name>
        <contact_address>FIRST FLOOR,NO7,behesht 7 alley, behesht bulivar, hakimiyeh  town, Tehran pars Thehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
