<?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>IRCT20180523039802N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-05</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of Schema Therapy on Eating Habits, Body Mass Index, Weight-related LifeStyle Self-Efficacy, Cognitive Emotion Regulation, Self-management Behaviors and Schema mentality in patients undergoing bariatric surgery</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of Schema Therapy on Eating Habits, Body Mass Index, weight-related LifeStyle Self-Efficacy, Cognitive Emotion Regulation, Self-management Behaviors, eating Addiction, Coping styles,  and Schematic mentality in patients undergoing bariatric surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39823</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Block randomization: 30 people who have the inclusion criteria: 15 people will be selected for the schema therapy in the experimental group and 15 people for the control group were randomly selected by the sealed envelope site. Block sizes were 4, 6, and 8, and the patients selected according to the patient list, Blinding description: The objectives of the research will be explained to the participants.
The objectives of the research will be explained to the participants.
Neither the participants in the experimental group know that there is a control group nor the participants in the control group know that there is an experimental group. Also, the groups are not related to each other.
The health care staff of the obesity clinic who are responsible for caring for patients, data collectors, and those evaluating the outcome are also blind and will not be informed of the objectives of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Schema received 10 sessions per week and 1.5 hours per week received. Intervention 2: Control group: The control group will not receive any interventions and will be considered as a comparison 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>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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Sobhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO. 5 Moallem street,  Moallem square</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7186837152</zip>
        <telephone>+98 71 3631 9937</telephone>
        <email>zahrasobhani120@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>ZAHRA SOBHANI</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, Moalem Ave, Moralem Square</address>
        <city>SHIRAZ</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7186837152</zip>
        <telephone>0087136319937</telephone>
        <email>zahrasobhani120@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Performing bariatric surgery in 1397, the age range of 55-20 years, living in Shiraz, having minimum cycle education, ability to communicate verbally, patient agreement with written consent to participate in the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Severe mental disorders and their related problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight and obesity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Schema received 10 sessions per week and 1.5 hours per week received</i_keyword>
      <i_keyword>Control group: The control group will not receive any interventions and will be considered as a comparison group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1-Weight Loss Life Style Self-Efficacy: This questionnaire, designed and developed by Clark, contains 20 questions about self-efficacy of eating behavior, in which subjects rate their confidence and control in controlling and preventing eating behaviors in different situations. The temptation is based on a five-point Likert scale (from 0 to 0, very reliable, 4). 2. Cognitive Emotion Regulation (DERS): A 36-point scale developed by Graz and Roemer And has a general score and six special scores in the sub-scales that relate to different dimensions of difficulty in tuning the emotion, including Emotional responsiveness, difficulty in targeting behavior, difficulty in controlling impulse, lack of emotional acuity, lack of emotional transparency, and limited access to emotion regulation strategies. 3-Schematic mentality: This questionnaire is a self-report tool with 124 sentences, and the subject must specify, on a 6-point Likert scale, the amount of his consent or opposition to each of the phrases. The higher the individual's score in these mindsets implies the inflexibility of that mentality. Timepoint: Before the start of the intervention, a pretest is taken and the schema therapy intervention will be performed in 10 sessions and a weekly 1.5 hour session, and then one month after the intervention, post-test will be taken. Method of measurement: Demographic information questionnaire, Linear scale, Weight Loss Life Style Self-Efficacy, Cognitive Emotion Regulation (DERS), BSSQ, Schematic mentality.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-12</approval_date>
        <contact_name>Shiraz university of medical sciences</contact_name>
        <contact_address>Khalili Street, Research Tower of Mohammad Rasool Allah, Colorectal Research Center shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
