<?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>IRCT20200210046451N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-06</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Comparison of the effectiveness of mindfulness cognitive group psychotherapy and schema therapy on weight, body image and self-esteem of people with obesity</public_title>
      <acronym></acronym>
      <scientific_title>The Comparison of the effectiveness of mindfulness cognitive group psychotherapy and schema therapy on weight, body image and self-esteem of people with obesity</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45772</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The block randomization method is performed by the statistical consultant as follows: Randomization is performed in two groups of mind-based cognitive group therapy and schema therapy. In block randomization, the number of participants in all groups will be very close together by making blocks of sequences so that the same number of participants are assigned to study groups within each group. We first code the groups in Latin letters as follows:
 A = Mindfulness-based cognitive group therapy, B = Schema therapy
In this study, with two groups A and B, we create the following two groups and assign each of the numbers 1 to 2:
-AB-BA
Then we use a random number table to select one of these blocks whenever the numbers 1 and 2 appear, and if there is another number, we consider it null and move on to the next choice. In fact, we have obtained a random sequence of numbers with a random number table that we consider the order of assignment for each number. This way the number of people in the groups will be approximately equal.</study_design>
      <phase>N/A</phase>
      <hc_freetext>obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group one: Mindfulness-based cognitive therapy was taught to participants based on Kabat‐Zinn (2012) in 8 sessions (two sessions per week, each session for 90 minutes) and during one month. Intervention 2: Intervention group II: In this study, intervention based on schema therapy was taught to the participants using the training package Young (1990) in 10 sessions (two sessions per week and each session for 90 minutes) for one and a half months.</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:
En Only part of the data, such as information about the main outcome or the like, can be shared.

When:
En Start of access period 6 months after printing results

To whom:
The data will be available only to researchers working in academic and scientific institutions

Conditions:
ny type of analysis on the data delivered is permitted

Where to obtain:
No. 5, 7 West Floor, Mellat Square, Alidoust Street, Ostad Hassan Bana North.
postal code: 2248795031
Tel: 00982122531934

How to obtain:
The request will be sent by email to: afshin_bahadori2002@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Afshin Bahadori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, 7 West Floor, Mellat Square, Alidoust Street, Ostad Hassan Bana North.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>2248795031</zip>
        <telephone>+98 21 2253 1934</telephone>
        <email>a.bahadori@iaukishint.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afshin Bahadori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, 7 West Floor, Mellat Square, Alidoust Street, Ostad Hassan Bana North.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>2248795031</zip>
        <telephone>+98 21 2253 1934</telephone>
        <email>a.bahadori@iaukishint.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Obesity based on physician diagnosis
age range from 30 to 50 years
diploma level to master's degree
no chronic diseases and mental disorders</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No cooperation of the sample group at each stage of the study
Having physical and physical problems and a history of psychiatric 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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group one: Mindfulness-based cognitive therapy was taught to participants based on Kabat‐Zinn (2012) in 8 sessions (two sessions per week, each session for 90 minutes) and during one month.</i_keyword>
      <i_keyword>Intervention group II: In this study, intervention based on schema therapy was taught to the participants using the training package Young (1990) in 10 sessions (two sessions per week and each session for 90 minutes) for one and a half months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>BMI. Timepoint: Measurement will be done in pre-test, post-test and follow-up three months after post-test. Method of measurement: This index is obtained by dividing the weight (in kg) by the square of the height (in meters). Weight will be measured using a digital portable balance scale with sensitivity of 100 grams and height will be measured with a 0.5 meter non-dilatable tape meter.</prim_outcome>
      <prim_outcome>Self-steem. Timepoint: Measurement will be done in pre-test, post-test and follow-up three months after post-test. Method of measurement: Cooper Smith Self-esteem Questionnaire.</prim_outcome>
      <prim_outcome>Body image. Timepoint: En Measurement will be done in pre-test, post-test and follow-up three months after post-test. Method of measurement: Kash Body Image Questionnaire.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-07</approval_date>
        <contact_name>Ethics committee of Hormozgan University Of Medical Sciences</contact_name>
        <contact_address>North Karegar Street 17 Veteran Street 24 P 64 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
