<?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>IRCT20190713044191N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-15</date_registration>
      <primary_sponsor>Vice chancellor for research, Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the efficacy of Cognitive-Behavioral Therapy for Perfectionism (CBT-P) versus Unified Protocol for Transdiagnostic Treatment (UP) in the individuals with emotional disorders</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficacy of Cognitive-Behavioral Therapy for Perfectionism (CBT-P) versus Unified Protocol for Transdiagnostic Treatment (UP) in the individuals with clinical perfectionism and anxiety and depressive disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40952</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After baseline assessment, participants are randomly allocated
to treatment or control conditions. Randomisation is conducted
using randomised number lists generated by Saghaei's (2004)
Random Allocation Software Version 1.0.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Major depressive disorder, single episode. Condition 2: Major depressive disorder, recurrent. Condition 3: Persistent mood disorders. Condition 4: Social phobia. Condition 5: Panic disorder. Condition 6: Generalized anxiety disorder. Condition 7: Mixed anxiety and depressive disorder. Condition 8: Other mixed anxiety disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Cognitive Behavioral Treatment of Perfectionism (CBT-P): It consists of 12 therapeutic sessions that have been developed step by step based on the protocol proposed by Egan et al, (2014). sessions are held individually and once a week and each session lasts one hour. Intervention 2: Intervention group 2: Unified Transdiagnostic Treatment (UP): It consists of 12 therapeutic sessions that have been developed step by step based on the protocol proposed by Barlow et al, (2011). sessions are held individually and once a week and each session lasts one hour. Intervention 3: Control group: waiting list.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is In this study, data will be reported collectively and there is no need to report individual data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Mahmoodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of clinical psychology, 4th floor, Ayatollah Taleghani Hospital, Arabi Ave, Yaman Ave, Daneshjoo Blvd, Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985711151</zip>
        <telephone>+98 21 2303 1548</telephone>
        <email>mmahmoodi13@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Mahmoodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of clinical psychology, 4th floor, Ayatollah Taleghani Hospital, Arabi Ave, Yaman Ave, Daneshjoo Blvd, Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985711151</zip>
        <telephone>+98 71 3727 3568</telephone>
        <email>mahmoodi_m13@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>To have elevated perfectionism, defined by a score greater than 24.7 on the Concern over Mistakes (CM) subscale of the Frost Multidimensional Perfectionism Scale
A score greater than18 on the depression (D) and greater than16 on the anxiety (A),  subscales of the DAS Scale
Diagnosis of one of anxiety disorders or depression at least, based on diagnostic criterias in DSM-5</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>self-harm behaviors
moderate or severe suicidality
psychosis
drug or substance abuse</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32</hc_code>
      <hc_code>F33</hc_code>
      <hc_code>F34</hc_code>
      <hc_code>F40.1</hc_code>
      <hc_code>F41.0</hc_code>
      <hc_code>F41.1</hc_code>
      <hc_code>F41.2</hc_code>
      <hc_code>F41.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode</hc_keyword>
      <hc_keyword>Major depressive disorder, recurrent</hc_keyword>
      <hc_keyword>Persistent mood [affective] disorders</hc_keyword>
      <hc_keyword>Social phobias</hc_keyword>
      <hc_keyword>Panic disorder</hc_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
      <hc_keyword>Mixed anxiety and depressive disorder</hc_keyword>
      <hc_keyword>Other mixed 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 1: Cognitive Behavioral Treatment of Perfectionism (CBT-P): It consists of 12 therapeutic sessions that have been developed step by step based on the protocol proposed by Egan et al, (2014). sessions are held individually and once a week and each session lasts one hour.</i_keyword>
      <i_keyword>Intervention group 2: Unified Transdiagnostic Treatment (UP): It consists of 12 therapeutic sessions that have been developed step by step based on the protocol proposed by Barlow et al, (2011). sessions are held individually and once a week and each session lasts one hour.</i_keyword>
      <i_keyword>Control group: waiting list</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The general severity of anxiety. Timepoint: At baseline, at the end of treatment, and 3 months after treatment. Method of measurement: Beck Anxiety Inventory.</prim_outcome>
      <prim_outcome>The general severity of depression. Timepoint: At baseline, at the end of treatment, and 3 months after treatment. Method of measurement: Beck Depression Inventory.</prim_outcome>
      <prim_outcome>The severity of social anxiety. Timepoint: At baseline, at the end of treatment, and 3 months after treatment. Method of measurement: Connor Social Phobia Inventory (SPIN).</prim_outcome>
      <prim_outcome>The severity of Panic. Timepoint: At baseline, at the end of treatment, and 3 months after treatment. Method of measurement: Anxiety Sensitivity Inventory (ASI).</prim_outcome>
      <prim_outcome>The level of perfectionism. Timepoint: At baseline, at the end of treatment, and 3 months after treatment. Method of measurement: The Frost Multidimensional Perfectionism Scale (FMPS).</prim_outcome>
      <prim_outcome>Emotion regulation strategies. Timepoint: At baseline, at the end of treatment, and 3 months after treatment. Method of measurement: Growth Emotion Regulation Questionnaire (ERQ).</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: At baseline, at the end of treatment, and 3 months after treatment. Method of measurement: WHO Quality of Life Questionnaire (WHOQOL).</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>Vice chancellor for research, Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-31</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Third Floor,  Faculty of Medicine, next toTaleghani Hospital, Evin, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
