<?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>IRCT20220226054129N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-05</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The Comparison of Face-To-Face Unified Transdiagnostic Therapy with Internet-Based Unified Transdiagnostic Therapy in Adolescents with Depressive and Anxiety Disorders</public_title>
      <acronym></acronym>
      <scientific_title>The Comparison Of Efficacy Of  Face-To-Face Unified Transdiagnostic Therapy With Internet-Based Unified Transdiagnostic Therapy In Reducing Symptoms And Improving The Function Of Adolescents With Depressive And Anxiety Disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62220</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this purpose, the method of "random allocation law" will be used for randomization. The researcher prepares 15 balls for group A, 15 balls for group B and 15 balls for group C and places them all in the lottery container. The balls are then randomly removed from the container without replacement and the sequence created is recorded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Major depressive disorder. Condition 2: Persistent mood disorders. Condition 3: Phobic anxiety disorders. Condition 4: Other anxiety disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in the first group will receive treatment face to face. Treatment sessions will be individual, and unified transdiagnostic treatment will be conducted in eleven 45-minute sessions weekly. Unified transdiagnostic treatment of adolescent emotional disorders refers to the Ehrenreich May et al. (2017) protocol. The unified protocol consists of four main parts, which are: increasing emotional awareness, facilitating flexibility in assessments, identifying and preventing behavioral and emotional avoidance, and situational and internal exposure to emotion clues. Intervention 2: Intervention group: People in the second group will receive treatment based on the Internet and through a website. This treatment is also designed based on unified protocol of transdiagnostic treatment of emotional disorders for adolescence. Intervention 3: Control group: During this period, no intervention will be performed for the control group, but after the end of the treatment time, the members of the control group will also be treated.</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>Hamid Poursharifi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Social Welfare and Rehabilitation, Kudakyar Alley, Daneshju Blvd., Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 2218 0045</telephone>
        <email>poursharifih@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasim Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 24, Pakzadnia Alley, West Mirzaee zeynali Ave., north Sohrevardi Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1576977619</zip>
        <telephone>+98 21 8850 8048</telephone>
        <email>nas.mousavi@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The diagnosis and the main problem of the person, based on the clinical interview by a clinical psychologist or psychiatrist, is a mood or anxiety disorder (combination of psychiatric problems including conduct disorders, attention deficit-hyperactivity disorder, eating disorders, non-interfering with treatment drug abuse, are acceptable, if the main problem is anxiety or depression).
The person has not had CBT treatment for anxiety or depression in the past.
Age between 12 and 18 years.
If the person is taking medication, a stable dose has been reached and it is necessary that this stable dose be obtained for SSRIs three months before the start of treatment and for benzodiazepines one month before the start of treatment.
Access to high speed internet at home.</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F30</hc_code>
      <hc_code>F34</hc_code>
      <hc_code>F40</hc_code>
      <hc_code>F41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, recurrent</hc_keyword>
      <hc_keyword>Persistent mood [affective] disorders</hc_keyword>
      <hc_keyword>Phobic anxiety disorders</hc_keyword>
      <hc_keyword>Other anxiety disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants in the first group will receive treatment face to face. Treatment sessions will be individual, and unified transdiagnostic treatment will be conducted in eleven 45-minute sessions weekly. Unified transdiagnostic treatment of adolescent emotional disorders refers to the Ehrenreich May et al. (2017) protocol. The unified protocol consists of four main parts, which are: increasing emotional awareness, facilitating flexibility in assessments, identifying and preventing behavioral and emotional avoidance, and situational and internal exposure to emotion clues.</i_keyword>
      <i_keyword>Intervention group: People in the second group will receive treatment based on the Internet and through a website. This treatment is also designed based on unified protocol of transdiagnostic treatment of emotional disorders for adolescence.</i_keyword>
      <i_keyword>Control group: During this period, no intervention will be performed for the control group, but after the end of the treatment time, the members of the control group will also be treated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcome is depression and is measured using the RCADS (Revised Child Anxiety and Depression Scale). Timepoint: The beginning of the intervention, the end of the intervention, three months after the end of the intervention. Method of measurement: RCADS (Revised Child Anxiety and Depression Scale).</prim_outcome>
      <prim_outcome>The primary outcome is anxiety and is measured using the RCADS (Revised Child Anxiety and Depression Scale). Timepoint: The beginning of the intervention, the end of the intervention, three months after the end of the intervention. Method of measurement: RCADS (Revised Child Anxiety and Depression 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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-12</approval_date>
        <contact_name>Ethics committee of University of Social welfare and rehabilitation sciences</contact_name>
        <contact_address>No. 9, P. 24, Pakzadnia Alley, West Mirzaee Zeynali Ave., North Sohrevardi Ave. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
