<?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>IRCT20180425039415N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-02</date_registration>
      <primary_sponsor>The University of Semnan- Psychology Faculty</primary_sponsor>
      <public_title>The efficacy of spiritual psychotherapy on obsessive- compulsive disorder</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of the efficacy of spiritual psycho therapy with cognitive behavioral therapy in groups on symptoms and related cognitive factors, religious obsession and spiritual health of clients with obsessive compulsive disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30914</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using simple random sampling, the subjects are randomly assigned to two groups of Spiritual Psychotherapy and Cognitive-Behavioral Therapy, and the central randomization method is used to hide the random allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obsessive- Compulsive Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Cognitive Behavioral intervention includes 10 treatment sessions of approximately 2 hours. The bulk of the program is the practices of Exposure  and   Response Prevention (Ritual) both in the treatment session and in the homework assignments, which adds to the difficulty of exposures as the treatment progresses. Intervention 2: Intervention group 2: Spiritual intervention for Obsessive-Compulsive disorder is provided by Dr. Mohammadi et al (independent of other psychotherapies) In the Psychological Research Center of Roozbeh Hospital in Tehran. This treatment protocol is run in 10 60-minute sessions. At each treatment session, we attempt to reduce and correct obsessive beliefs through spiritual therapy components.</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>Somayeh Alimadadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2, Vaez Najaf Abadi Aley, Khorasan St, Khorasan Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1176818371</zip>
        <telephone>+98 21 3370 5129</telephone>
        <email>s.alimadadi@semnan.ac.ir</email>
        <affiliation>Semnan University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mahmood Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Education and Psychology Faculty of Semnan university,Mahdishahr.</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3564111156</zip>
        <telephone>+98 23 3362 4250</telephone>
        <email>m_najafi@semnan.ac.ir</email>
        <affiliation>Semnan University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Getting detection of Obsessive-Compulsive disorder based on DSM V diagnostic criteria by psychiatrist
Have reading and writing skills</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Concomitant disorders diagnosed through the Persian version of the Structured Clinical Interview for I-axis Disorders (SCID)
Having any systemic disorders including Cardiovascular disease
Having history of Bipolar disorder, Psychosis, history of drug abuse, developmental impairment and mental retardation
Drug use in the last 1 month
Drug and alcohol use during the past 1 month
Suicide attempt</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>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Cognitive Behavioral intervention includes 10 treatment sessions of approximately 2 hours. The bulk of the program is the practices of Exposure  and   Response Prevention (Ritual) both in the treatment session and in the homework assignments, which adds to the difficulty of exposures as the treatment progresses.</i_keyword>
      <i_keyword>Intervention group 2: Spiritual intervention for Obsessive-Compulsive disorder is provided by Dr. Mohammadi et al (independent of other psychotherapies) In the Psychological Research Center of Roozbeh Hospital in Tehran. This treatment protocol is run in 10 60-minute sessions. At each treatment session, we attempt to reduce and correct obsessive beliefs through spiritual therapy components.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Obsession and Compulsion Symptoms. Timepoint: At the beginning of the study (before the intervention) and after the Intervention, after three months of follow-up. Method of measurement: Yale Brown Scale.</prim_outcome>
      <prim_outcome>Obsessive Beliefs. Timepoint: At the beginning of the study (before the intervention) and after the intervention, after three months of follow-up. Method of measurement: Obsessive Beliefs Questionnaire.</prim_outcome>
      <prim_outcome>Thought- Action Fusion. Timepoint: At the beginning of the study (before the intervention) and after the intervention, after three months of follow-up. Method of measurement: Thought- Action Fusion Scale.</prim_outcome>
      <prim_outcome>Religious Obsession. Timepoint: At the beginning of the study (before the intervention) and after the intervention, after three months of follow-up. Method of measurement: Peen Inventory of Scrupulosity.</prim_outcome>
      <prim_outcome>Spiritual Health. Timepoint: At the beginning of the study (before the intervention) and after the intervention, after three months of follow-up. Method of measurement: Spiritual Health 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>This is a PHD Dissertation</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-12</approval_date>
        <contact_name>Ethics committee of Semnan University of Medical Science</contact_name>
        <contact_address>Central Setad of Semnan University of Medical Science, Basij Boulevard, Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
