<?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>IRCT20210504051176N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-18</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effectiveness and Comparison of three Intervention Models in Patients with Obsessive - Compulsive Disorder.</public_title>
      <acronym>OCD</acronym>
      <scientific_title>The Comparison of the Effectiveness  of cognitive rehabilitation based Rehacoms cognitive software with exposure and response prevention ( ERP ) and drug intervention  in improving neuropsychological deficits and clinical associates in patient with Obsessive Compulsive disorder.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>6</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67774</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: None of the patients knew which treatment groups they belonged to.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obsessive  Compulsive Disorder.</hc_freetext>
      <i_freetext>First intervention group: Includes drug intervention that is performed by a psychiatrist. Second intervention group: Includes behavioral therapy based on exposure and response prevention (ERP) method. (It is based on the Foa protocol and et al, 2001) which is codified and perform by the researcher.Third intervention group: Includes a cognitive rehabilitation intervention that is carried a rehabilitation co therapist.Two months after the completion of therapeutic interventions, the samples will be re-evaluated in order to follow the process of changes..</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:
After removing the confidential information, the files related to demographic and interventional  information can be provided to clinical psychologists

When:
After all articles are published

To whom:
Clinical Psychologists

Conditions:
In order to collaborate scientifically, but they are not allowed to analyze and publish

Where to obtain:
Refer to the researcher's email 
(Shamsoddin kahani)

How to obtain:
After the publication of the article and proof of acquaintance, send an email for the experimental design of a single subject. Approximate delivery time mwill be 2 to 3 months

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shamsoddin Kahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Starkhan-Kh. Niyaish-St. Hazrat Rassol Akram Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6435 2400</telephone>
        <email>Sh.kahani@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shamsoddin kahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The 5 km of Sadra,city, Shiraz Islamic Azad University</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7198774731</zip>
        <telephone>+98 21 8887 3302</telephone>
        <email>Sh.kahani@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of Obsessive Compulsive Disorder, age 17 to 48 years,12 years schooling and higher education level, and commitment to participate in research and not participating in other therapies at the same time.</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>48 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>It includes the absence of more than two sessions, comorbidity of OCD with psychotic or bipolar disorder, suicidal ideation or attempt in the last 6 months, substance abuse or Alcohol abuse.</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: Includes drug intervention that is performed by a psychiatrist. Second intervention group: Includes behavioral therapy based on exposure and response prevention (ERP) method. (It is based on the Foa protocol and et al, 2001) which is codified and perform by the researcher.Third intervention group: Includes a cognitive rehabilitation intervention that is carried a rehabilitation co therapist.Two months after the completion of therapeutic interventions, the samples will be re-evaluated in order to follow the process of changes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Neuropsychological problems. Timepoint: Before the intervention, Treatment sessions, After the intervention, 2 months the end of the intervention (follow up). Method of measurement: Neuropsychological tests such as Wisconsin Card, Stroop Test, etc.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Severity of Obsessive Compulsive Disorder. Timepoint: Before the intervention, Treatment sessions, After the intervention,  2 months after the end of the intervention(follow up ). Method of measurement: Yale Brown Obsessive Compulsive  Scale.</sec_outcome>
      <sec_outcome>Severity of Depression. Timepoint: Before the intervention, Treatment sessions, After the intervention, 2 month after the end of the intervention(follow up). Method of measurement: Beck depression Inventory.</sec_outcome>
      <sec_outcome>Severity of Anxiety. Timepoint: Before the intervention, Treatment sessions, After the intervention, 2 month after the end of the intervention(follow up). Method of measurement: Beck Anxiety Inventory.</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>2022-06-15</approval_date>
        <contact_name>Islamic Azad University Shiraz Unit</contact_name>
        <contact_address>Shiraz, km 5 of Sadra city, Shiraz Islamic Azad University campus Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
