<?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>IRCT20210511051261N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-10</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the effect of schema therapy, emotional schema therapy and exposure and prevention of response in obsessive-compulsive clinical disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of schema therapy, emotional schema therapy and exposure and prevention of response to rumination, irrational beliefs, guilt, distress tolerance, extreme responsibility, perfectionism, emotion regulation and clinical symptoms in people with obsessive-compulsive disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57276</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sample will be selected from the members of the statistical community using the available sampling method based on inclusion and exclusion criteria. Then, they will be assigned to three intervention groups and one control group based on simple randomization sampling method using a random number table. Thus, first, a list of people eligible to participate in the study will be prepared. Then by considering the numbers for different groups (15-00 for intervention group 1, 16-30 for intervention group 2, 31-45 for intervention group 3 and 46-60 numbers for control group) and for moving up and down , Is placed on one of the numbers in the table and the numbers are recorded and the random order of people entering one of the groups will be determined.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obsessive-compulsive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: They will receive the therapy schema individually according to the treatment protocol of Young et al. (2003) for 20 sessions, each session lasting 45 minutes. Intervention 2: Intervention group 2: They will receive emotion therapy schema individually based on Leahy et al. (2016) treatment protocol for 15 sessions, each session lasting 45 minutes. Intervention 3: Intervention group 3: They will receive exposure and response prevention individually based on the treatment protocol of Jones et al. (1998) for 10 sessions, each session lasting 45 minutes. Intervention 4: Control group: They will not receive treatment during research.</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:
Clinical outcomes of the study will be published in the form of a paper.

When:
The results of the study will be published at the earliest opportunity after data collection.

To whom:
Data documentation will be shared in the form of an article.

Conditions:
The data will be provided to researchers working in academic institutions and counseling centers and psychological services with the permission of the Islamic Azad University of Lahijan.

Where to obtain:
The data will be provided to researchers working in academic institutions and counseling centers and psychological services after receiving permission from the Islamic Azad University of Lahijan.

How to obtain:
Researchers must obtain written permission from the Vice Chancellor for Research, Islamic Azad University, Lahijan Branch.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masood Ahovan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Himan Counseling and Psychological Services Center, second floor, No. 300, between Piroozi 34 and 36, Piroozi Boulevard</address>
        <city>Mahhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9193974364</zip>
        <telephone>+98 51 3844 6116</telephone>
        <email>Masood.ahvan@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masood Ahovan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Himan Counseling and Psychological Services Center, second floor, No. 300, between Piroozi 34 and 36, Piroozi Boulevard</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9193974364</zip>
        <telephone>+98 51 3844 6116</telephone>
        <email>Masood.ahvan@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Diagnosis of Obsessive-Compulsive Disorder Based on Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition
Obtaining a score of 11 and above from the Maudsley obsessive-compulsive disorder questionnaire
Have at least a third level of secondary education
Lack of comorbidity with other psychiatric disorders
Lack of having other physical diseases
Not receiving psychotherapy and medication for obsessive-compulsive disorder before entering the research</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a history of substance abuse
Having suicidal thoughts and and history of doing so</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 - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: They will receive the therapy schema individually according to the treatment protocol of Young et al. (2003) for 20 sessions, each session lasting 45 minutes.</i_keyword>
      <i_keyword>Intervention group 2: They will receive emotion therapy schema individually based on Leahy et al. (2016) treatment protocol for 15 sessions, each session lasting 45 minutes.</i_keyword>
      <i_keyword>Intervention group 3: They will receive exposure and response prevention individually based on the treatment protocol of Jones et al. (1998) for 10 sessions, each session lasting 45 minutes.</i_keyword>
      <i_keyword>Control group: They will not receive treatment during research.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Rumination. Timepoint: Before intervention, after intervention, six months after intervention. Method of measurement: Ruminant Response Style Questionnaire (RRS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Irrational beliefs. Timepoint: Before intervention, after intervention, one month after intervention, three months after intervention. Method of measurement: Jones Irrational Beliefs Questionnaire (IBT).</sec_outcome>
      <sec_outcome>Guilty. Timepoint: Before intervention, after intervention, one month after intervention, three months after intervention. Method of measurement: Kugler &amp; Jones Guilty Questionnaire.</sec_outcome>
      <sec_outcome>Tolerance of distress. Timepoint: Before intervention, after intervention, one month after intervention, three months after intervention. Method of measurement: Simons and Gaher Distress Scale (DTS).</sec_outcome>
      <sec_outcome>Extreme responsibility. Timepoint: Before intervention, after intervention, one month after intervention, three months after intervention. Method of measurement: California Accountability Questionnaire.</sec_outcome>
      <sec_outcome>Perfectionism. Timepoint: Before intervention, after intervention, one month after intervention, three months after intervention. Method of measurement: Hill et al. Perfectionism Scale (2004).</sec_outcome>
      <sec_outcome>Emotion Regulation. Timepoint: Before intervention, after intervention, one month after intervention, three months after intervention. Method of measurement: Jahn &amp; Gross Emotion Regulation Questionnaire.</sec_outcome>
      <sec_outcome>Clinical syndrome of obsessive-compulsive disorder. Timepoint: Before intervention, after intervention, one month after intervention, three months after intervention. Method of measurement: Structured clinical interview for Axis Disorders 1.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-14</approval_date>
        <contact_name>Research Ethics Committee of Islamic Azad University, Lahijan Branch</contact_name>
        <contact_address>Islamic Azad University of Lahijan, End of Shaghayegh St., East Kashif St. Lahijan Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
