<?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>IRCT20171011036722N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-30</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Unified Transdiagnostic Therapy and cognitive Behavioural Therapy On  Obese children</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Unified Transdiagnostic Therapy and cognitive Behavioural Therapy On Negative affect, Anexiety, Shame, Self-criticism and Difficulties in Emotional Regulation in Obese children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>51</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59782</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomized clinical trial in which obese children ranged in age from 7 to 15 years. Sampling is available from schools in Zarrinshahr and Fooladshahr, Isfahan. The sample size was proposed using G power software considering H1 0.4, alpha 0.5, power 0.8 and H0 equal to three sample groups with a volume of 51 people (17 people in each group). Using a simple randomization method with an individual randomization unit, randomization is performed from a computer sequence, which is numbered, sealed, hidden and stored in the center. The website https://www.Randomization.com is used online for random allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obese children.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Integrative Transdiagnostic treatmentSession 1: Familiarity of group members with each other and establishing a therapeutic relationship, familiarity of children and their parents with the research topic and preliminary explanations will be explained to the group members.Session 2: Recognizing Emotions and Orienting Here and Now, Participants are asked to express their positive and negative emotions. ARC Emotional Experience Model Training. The purpose of this training is to be aware of the patterns of individual emotional response and the factors that create and maintain these patterns.Session 3 and 4: Review of the homework of the previous session. Learn to observe emotional experience and react to emotions using mindfulness techniques.Session 5: Reviewing the homework of the previous session will be done at the beginning of the muscle relaxation session for more concentration and self-awareness training. In this session, behaviors affected by emotion and creating inconsistent behaviors and emotional encounters are performed.Session 6: Assign the previous session to review and give feedback. In this session, maladaptive behaviors affected by emotion and their role in the continuation of unhappiness, negative emotions and feelings of shame, are discussed. The role of physical feelings and negative evaluations of one's appearance, the role of others' evaluation in creating excitement and finally the feeling of worry and shame about one's appearance and the stability of these feelings will be discussed.Session 7: Review the homework of the previous session. Introducing a three-dimensional behavioral model to express the common relationship between behavior, emotions, psychological functions and observable behavior. In this way, a model is presented in which a simulation of the interaction between thoughts, behaviors and feelings is explained, and there is an interaction between them.Session 8: Review the homework of the previous session. Participants should be able to express the interrelationships between thoughts and emotions and feelings of shame and notice errors in their perceptions. An overview of treatment is given in this session. Get feedback from participants.Follow-up session: In this session, the general concepts of treatment are reviewed and the participants' therapeutic progress is examined. Intervention 2: Intervention group: cognitive behavioral therapySession 1: Familiarity of group members with each other and establishing a therapeutic relationship, familiarity of children and their parents with the research topic and preliminary explanations will be explained to the group members.Session 2: In this session, we will teach different feelings and emotions and name them. In order for the subject to know his feelings and emotions better.Session 3: In this session, we ask the subjects about their appearance and how they perceive these physical changes.Session 4: In this session, the topics of the previous session are explained in more detail. Subjects should first express their emotions about their appearance and changes and pay more attention to the thoughts they had after these emotions.Session 5: Review the assignment of the previous session and give feedback to the subjects. In this session, we will teach the possibility of having different ways of thinking with our own way of thinking.Session 6: Review the assignment of the previous session, review the alternative thoughts of dysfunctional thoughts and also review the results of these thoughts. In this session, we should have more emphasis on thoughts and their effect on the body and emotions.Session 7: In this session, the focus is more on the evaluations of others than the appearance of the subjects. To do this, explain to the group members how each person is different and worried about different things.Session 8: Learn how to turn your problems into smaller, more accessible steps. It is important to note that identifying thoughts, emotions, and emotions is the result. And correcting thinking will lead to more positive emotions.Follow-up session: In this session, the general concepts of treatment are reviewed and the participants' therapeutic progress is examined. Intervention 3: Control group: They do not receive any intervention.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Amirsam Kianimghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran - Shahid Chamran Highway - Yemen Street - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 2303 1548</telephone>
        <email>as.kianimghadam@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amirsam Kianimoghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran - Shahid Chamran Highway - Yemen Street - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 2303 1548</telephone>
        <email>as.kianimoghadam@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Overweight and obesity in children - 7 to 15 years old - Having primary education - Completing the informed consent form based on voluntary participation in the study and not receiving psychological services outside the treatment session by parents - Conducting a clinical interview and confirming the child's dissatisfaction with Overweight</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>15 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having diagnostic criteria for obvious psychiatric disorders based on clinical interview - Parents' dissatisfaction with the child's presence in treatment sessions - History of hospitalization in psychiatric wards - Use of psychiatric drugs - Participation in treatment programs related to research treatment methods during the last six months-Reluctance to continue treatment</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>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Integrative Transdiagnostic treatmentSession 1: Familiarity of group members with each other and establishing a therapeutic relationship, familiarity of children and their parents with the research topic and preliminary explanations will be explained to the group members.Session 2: Recognizing Emotions and Orienting Here and Now, Participants are asked to express their positive and negative emotions. ARC Emotional Experience Model Training. The purpose of this training is to be aware of the patterns of individual emotional response and the factors that create and maintain these patterns.Session 3 and 4: Review of the homework of the previous session. Learn to observe emotional experience and react to emotions using mindfulness techniques.Session 5: Reviewing the homework of the previous session will be done at the beginning of the muscle relaxation session for more concentration and self-awareness training. In this session, behaviors affected by emotion and creating inconsistent behaviors and emotional encounters are performed.Session 6: Assign the previous session to review and give feedback. In this session, maladaptive behaviors affected by emotion and their role in the continuation of unhappiness, negative emotions and feelings of shame, are discussed. The role of physical feelings and negative evaluations of one's appearance, the role of others' evaluation in creating excitement and finally the feeling of worry and shame about one's appearance and the stability of these feelings will be discussed.Session 7: Review the homework of the previous session. Introducing a three-dimensional behavioral model to express the common relationship between behavior, emotions, psychological functions and observable behavior. In this way, a model is presented in which a simulation of the interaction between thoughts, behaviors and feelings is explained, and there is an interaction between them.Session 8: Review the homework of the previous session. Participants should be able to express the interrelationships between thoughts and emotions and feelings of shame and notice errors in their perceptions. An overview of treatment is given in this session. Get feedback from participants.Follow-up session: In this session, the general concepts of treatment are reviewed and the participants' therapeutic progress is examined.</i_keyword>
      <i_keyword>Intervention group: cognitive behavioral therapySession 1: Familiarity of group members with each other and establishing a therapeutic relationship, familiarity of children and their parents with the research topic and preliminary explanations will be explained to the group members.Session 2: In this session, we will teach different feelings and emotions and name them. In order for the subject to know his feelings and emotions better.Session 3: In this session, we ask the subjects about their appearance and how they perceive these physical changes.Session 4: In this session, the topics of the previous session are explained in more detail. Subjects should first express their emotions about their appearance and changes and pay more attention to the thoughts they had after these emotions.Session 5: Review the assignment of the previous session and give feedback to the subjects. In this session, we will teach the possibility of having different ways of thinking with our own way of thinking.Session 6: Review the assignment of the previous session, review the alternative thoughts of dysfunctional thoughts and also review the results of these thoughts. In this session, we should have more emphasis on thoughts and their effect on the body and emotions.Session 7: In this session, the focus is more on the evaluations of others than the appearance of the subjects. To do this, explain to the group members how each person is different and worried about different things.Session 8: Learn how to turn your problems into smaller, more accessible steps. It is important to note that identifying thoughts, emotions, and emotions is the result. And correcting thinking will lead to more positive emotions.Follow-up session: In this session, the general concepts of treatment are reviewed and the participants' therapeutic progress is examined.</i_keyword>
      <i_keyword>Control group: They do not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Negative affect. Timepoint: Measurement of negative affect variable using a questionnaire before starting treatment and after receiving 8 sessions of treatment. Method of measurement: Abustani Children Negative and Positive Emotion Scale Short Form.</prim_outcome>
      <prim_outcome>Emotion Regulation. Timepoint: Measurement of Emotion Regulation variable using a questionnaire before starting treatment and after receiving 8 sessions of treatment. Method of measurement: Shield Child and Adolescent Form Emotion Regulation Checklist.</prim_outcome>
      <prim_outcome>Self-Critical. Timepoint: Measurement of Self-Critical variable using a questionnaire before starting treatment and after receiving 8 sessions of treatment. Method of measurement: Thompson and Zarov Self-Critical Inventory.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Measurement of Anxiety variable using a questionnaire before starting treatment and after receiving 8 sessions of treatment. Method of measurement: Maurice Child and Adolescent Anxiety Inventory.</prim_outcome>
      <prim_outcome>Shame. Timepoint: Measurement of shame  variable using a questionnaire before starting treatment and after receiving 8 sessions of treatment. Method of measurement: Gross et shame Scale.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-26</approval_date>
        <contact_name>Working Group of Ethics Committee in Research, School of Medicine, Shahid Beheshti University of Med</contact_name>
        <contact_address>Tehran - Shahid Chamran Highway - Yemen Street - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
