<?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>IRCT20210914052475N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-10</date_registration>
      <primary_sponsor>Research &amp; technology assistance of Kharazmi University</primary_sponsor>
      <public_title>Augmenting cognitive behavioral therapy for obsessive-compulsive disorder with anti-disgust cognitive intervention</public_title>
      <acronym></acronym>
      <scientific_title>Augmenting efficacy of cognitive behavioral therapy with anti-disgust cognitive intervention on disgust propensity/ sensitivity, emotion acceptance, and OCD severity in patients with obsessive-compulsive disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58754</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization will be performed by a research assistant through the lottery method. First, the research assistant will give a code to each participant who met the eligibility criteria. The mentioned codes will be written on paper. Then, he will be poured all papers into an opaque container and intermittently allocated each participant to each group, Blinding description: The process of evaluation, randomization, and treatment for all participants will be conducted in two separate centers. In the first center, each participant will be evaluated by a research assistant who is blind to the study's objectives. He will assign each participant to one of two groups, as described in the randomization procedure. Then, each participant will refer to the second center to start the interventions. The second center is located at a one-kilometer distance from the first center. Therapists, researchers, evaluators, and data analysts will also present at the second center and will be utterly blind to the study objectives and which participant belonged to which group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obsessive_compulsive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: cognitive-behavioral therapy plus anti-disgust cognitive intervention, 15 weekly sessions, time of each session: 90 minutes, case conceptualization, disgust-related cognitive psychoeducation &amp; intervention, exposure and response prevention, relapse prevention. Intervention 2: Control group: cognitive-behavioral therapy, 15 weekly sessions, time of each session: 90 minutes, case conceptualization, exposure and response prevention, relapse prevention.</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 Privacy of personal information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Behzad Salmani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iman 12 alley, Shahid Beheshti square, enghelab town, Meshkat</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87391-14384</zip>
        <telephone>+98 31 5568 3234</telephone>
        <email>b.salmani1365@gmail.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Behzad Salmani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iman 12 alley, Shahid beheshti square, enghelab town, Meshkat</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87391-14384</zip>
        <telephone>+98 31 5568 3234</telephone>
        <email>b.salmani1365@gmail.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being at least 18 years old in the beginning of the study.
Having an education grade equal to 12 or more.
Diagnose with contamination-based obsessive-compulsive disorder as a primary diagnosis.
Having a stable dose of medication from 3 months before the beginning of the study.
Completing informed constant form.</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diagnose with other comorbid psychiatric disorders or conditions except for major depressive disorder.
Having a history of traumatic head injury or epilepsy.</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: cognitive-behavioral therapy plus anti-disgust cognitive intervention, 15 weekly sessions, time of each session: 90 minutes, case conceptualization, disgust-related cognitive psychoeducation &amp; intervention, exposure and response prevention, relapse prevention.</i_keyword>
      <i_keyword>Control group: cognitive-behavioral therapy, 15 weekly sessions, time of each session: 90 minutes, case conceptualization, exposure and response prevention, relapse prevention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disgust propensity/ sensitivity. Timepoint: Pre-treatment, before exposure and response prevention sessions, post-treatment, three-month follow-up. Method of measurement: Disgust Propensity/ Sensitivity Scale (DPSS).</prim_outcome>
      <prim_outcome>Obsessive-compulsive disorder severity. Timepoint: Pre-treatment, before exposure and response prevention sessions, post-treatment, three-month follow-up. Method of measurement: Yale-Brown Obsessive Compulsive Scale (Y-BOCS).</prim_outcome>
      <prim_outcome>Emotion acceptance. Timepoint: Pre-treatment, before exposure and response prevention sessions, post-treatment, three-month follow-up. Method of measurement: Non-judging &amp; non-reactivity sub-scales of Five Facets Mindfulness Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Acceptance rate of exposure and response prevention. Timepoint: Before exposure and response prevention sessions. Method of measurement: Percent of acceptance of exposure and response prevention.</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>Research &amp; technology assistance of Kharazmi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-14</approval_date>
        <contact_name>Ethic committee of Kharazmi University</contact_name>
        <contact_address>Somayyeh building, Kharazmi University, South Moffateh st, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
