<?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>IRCT20141108019855N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-28</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of emotional Schemas Therapy augmented exposure and response prevention on obsessive - compulsive disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of emotional schemas therapy augmented exposure and response prevention, drug therapy and exposure and response prevention treatment on obsessive-compulsive, anxiety and depression symptoms, obsessional beliefs and quality of life in people with obsessive - compulsive disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35883</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients enter the treatment groups based on the lottery, Blinding description: In addition to the original researcher, the evaluator is also blind.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Obsessive-compulsive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Emotional Schemas Therapy augmented exposure and response prevention: In the initial stage (sessions 1-3), establishing a therapeutic relationship, measuring and evaluating emotional schemas, formulating the case, providing treatment logic and therapeutic goals, teaching on obsessive-compulsive disorder, and presenting a model of anthropology and explaining the treatment of emotional schema Preliminary explanation and presentation of the logic of confrontation and prevention of a brief response, attention to the patient's adaptive and non-adaptive emotions, and the presentation of the task of emotional functioning are emphasized.In the changing phase (sessions 4-10), addressing the patient's painful excitement and patient emotional schemas, and designing behavioral experiments to challenge them, presenting the task, describing emotions and challenges with troublesome emotional schemas (accepting emotions, validating emotions ) Is considered. Also, confrontational meetings begin by identifying anxiety and hierarchy.In the final phase (sessions 10-14), focusing on transferring new skills and achievements to the living environment and preventing recurrence is carried out, and the final summing up of the lessons is assessed and reassessed. Intervention 2: Intervention group 2: exposure and response prevention; The focus of these meetings is on: Reviewing the patient's reactions to the previous treatment session, Assessing the task of the previous session, logic of treatment and self-review forms, Collecting detailed information from obsessive-compulsive symptoms, Providing a hierarchy of all anxious situations, Performing confrontation with initial cases in a hierarchy (starting to confront situations with moderate anxiety), Providing treatment plan, Providing final summaries and feedback. Intervention 3: Control group: drug therapy: the patients in the control group received SSRIs.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samira Masumian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mansouri Alley, Nayesh Street, Sattarkhan Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۵۶۱۳۱۱۱</zip>
        <telephone>+98 21 6655 1616</telephone>
        <email>samira.masumian@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samira Masumian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mansouri Alley, Nayesh Street, Sattarkhan Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۵۶۱۳۱۱۱</zip>
        <telephone>+98 21 6655 1616</telephone>
        <email>samira.masumian@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having Diagnostic Criteria for Obsessive-Compulsive Disorder
Having at least a cycle education level
Having a minimum age of 18 and a maximum of 50 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suicidal thoughts
Psychotic disorder based on SCID-5-CV 
Substance use and abuse and dependence on any substance
severe personality disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F42</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obsessive-compulsive disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Emotional Schemas Therapy augmented exposure and response prevention: In the initial stage (sessions 1-3), establishing a therapeutic relationship, measuring and evaluating emotional schemas, formulating the case, providing treatment logic and therapeutic goals, teaching on obsessive-compulsive disorder, and presenting a model of anthropology and explaining the treatment of emotional schema Preliminary explanation and presentation of the logic of confrontation and prevention of a brief response, attention to the patient's adaptive and non-adaptive emotions, and the presentation of the task of emotional functioning are emphasized.In the changing phase (sessions 4-10), addressing the patient's painful excitement and patient emotional schemas, and designing behavioral experiments to challenge them, presenting the task, describing emotions and challenges with troublesome emotional schemas (accepting emotions, validating emotions ) Is considered. Also, confrontational meetings begin by identifying anxiety and hierarchy.In the final phase (sessions 10-14), focusing on transferring new skills and achievements to the living environment and preventing recurrence is carried out, and the final summing up of the lessons is assessed and reassessed.</i_keyword>
      <i_keyword>Intervention group 2: exposure and response prevention; The focus of these meetings is on: Reviewing the patient's reactions to the previous treatment session, Assessing the task of the previous session, logic of treatment and self-review forms, Collecting detailed information from obsessive-compulsive symptoms, Providing a hierarchy of all anxious situations, Performing confrontation with initial cases in a hierarchy (starting to confront situations with moderate anxiety), Providing treatment plan, Providing final summaries and feedback.</i_keyword>
      <i_keyword>Control group: drug therapy: the patients in the control group received SSRIs.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Obsessive symptoms. Timepoint: Before, immediately after and two months after treatment. Method of measurement: Yale-Brown Obsessive-Compulsive Scale-Second Edition.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before, after and two months after treatment. Method of measurement: Four Systems Anxiety Questionnaire (FSAQ):.</prim_outcome>
      <prim_outcome>Obsessive beliefs. Timepoint: Before, after and two months after treatment. Method of measurement: Obsessive-Verbal Questionnaire.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before, after and two months after treatment. Method of measurement: Quality of Life 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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-23</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Next to Milad Tower, Hemat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
