<?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>IRCT20210101049908N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-08</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of unified trans diagnostic treatment on emotional problems among adolescents with high body mass index ( BMI)</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of unified trans diagnostic treatment on shame, self-criticism emotional dysregulation and emotional eating among adolescents with high body mass index ( BMI)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53439</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, the available sample of patients referred to Dr. Farsani nutrition clinics is selected and finally, based on the list of patients, random sampling is done by throwing dice. Numbers 1, 3, 5 were assigned to the patient to the treatment group and numbers 2, 4 and 6 were assigned to the patient to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>OBESITY.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Includes diet plan and psychological intervention. The psychological intervention will use an unified protocol of transdiagnostic for adolescents, which is a 16-session intervention. Each session is 55 minutes. This treatment consists of 8 parts that include motivation for treatment, diagnosis and tracking of emotional experiences, emotional awareness training, cognitive flexibility, emotional avoidance, emotion-driven behaviors, awareness of bodily senses and their tolerance, endogenous exposure to emotions. Intervention 2: Control group: Just get a diet without getting psychological 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
result. tables and treatment protocol

When:
from 1400

To whom:
qualified applicants , medical graduates, specialized fellowship , psychiatrists, clinical and health psychologists, adolescents psychologists , nutritions

Conditions:
repeated measures of analysis

Where to obtain:
parastoo Naeimijoo( pnaeimijoo1392@gmail)

How to obtain:
The applicant must first submit their application by an academic email to the corresponding and then the request will be checked within one week and if approved the data will be sent

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas Masjedi Arani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University of Medical Sciences, Arabi Alley , Daneshjoo St,  Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 23871</telephone>
        <email>doctormasjedi@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>parastoo Naimijoo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University of Medical Sciences, Arabi Alley , Daneshjoo St,  Velenjak.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 23871</telephone>
        <email>pnaeimijoo1392@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age range between 12 to 18 years
being obese based on Body Mass Index
Absence of a current or lifetime eating disorder (anorexia nervosa, Bulimia nervosa) according to the  5 Diagnostic and statistical manual of mental disorders (DSM-5)
no dependency on or abusing substance or alcohol
absence of severe psychiatric disorder(schizophrenia, pervasive developmental , bipolar type 1 and 2 , obsessive compulsive disorder , suicidal or homicidal ideation or plan)</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>receiving weight-loss medication
candidate of bariatric surgery
inability of the patient to access the medical centre
receiving concomitant psychological treatment or 6 months prior to the study
simultaneous use of other psychiatric medication</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z68.54</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Body mass index (BMI) pediatric, greater than or equal to 95th percentile for age</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Includes diet plan and psychological intervention. The psychological intervention will use an unified protocol of transdiagnostic for adolescents, which is a 16-session intervention. Each session is 55 minutes. This treatment consists of 8 parts that include motivation for treatment, diagnosis and tracking of emotional experiences, emotional awareness training, cognitive flexibility, emotional avoidance, emotion-driven behaviors, awareness of bodily senses and their tolerance, endogenous exposure to emotions</i_keyword>
      <i_keyword>Control group: Just get a diet without getting psychological intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>BODY SHAME. Timepoint: Before the intervention, after the intervention (60 days after the first evaluation), 60 days after the end of intervention. Method of measurement: Body image shame scale.</prim_outcome>
      <prim_outcome>Self-criticism. Timepoint: Before the intervention, after the intervention (60 days after the first evaluation), 60 days after the end of intervention. Method of measurement: Gilbert self criticism scale.</prim_outcome>
      <prim_outcome>Emotion dysregulation. Timepoint: Before the intervention, after the intervention (60 days after the first evaluation), 60 days after the end of intervention. Method of measurement: difficulties in emotion regulation scale.</prim_outcome>
      <prim_outcome>Emotional eating. Timepoint: Before the intervention, after the intervention (60 days after the first evaluation), 60 days after the end of intervention. Method of measurement: emotional eating scale of Dutch.</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>2020-12-21</approval_date>
        <contact_name>Ethics committee of medical faculty shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciences, Arabi Alley , Daneshjoo St,  Velenjak. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
