<?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>IRCT20120225009127N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-14</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Design of the package of spiritual psychotherapy to treat clients with obsessive- compulsive disorder (OCD), and comparison of its effectiveness with cognitive behavior therapy (CBT)</public_title>
      <acronym></acronym>
      <scientific_title>Design and implementation of the package of spiritual psychotherapy to treat clients with obsessive- compulsive disorder (OCD), and comparison of its effectiveness with cognitive behavior therapy (CBT)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51856</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple randomization method is performed individually using computer software. Allocation concealment is not used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>obsessive- compulsive disorder (OCD).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, firstly the Spiritual Psychotherapy package is designed for people with OCD, then face and content validity is also evaluated using focus group discussions with experts. 30 clients with obsessive-compulsive disorder are randomly assigned to two intervention programs (spiritual psychotherapy, cognitive-behavioral therapy). The spiritual psychotherapy package is presented in twelve 90-minute group sessions, two sessions per week, for 15 clients with OCD, by a familiar spiritual psychotherapist who is proficient in performing the spiritual psychotherapy package. Spiritual psychotherapy sessions include: Familiarity with the treatment framework and obsessive-compulsive disorder. Realization and analysis of obsessive beliefs. Responsibility. Flexibility and quitting habits. Targeting. Forgiveness. Love of self. Love of others, work and belongings. Belief in sacred. Spiritual awareness, belief in transformation and change of religious obsessions. Prepare for the end and prevent recurrence. Intervention 2: Intervention group: 30 clients with obsessive-compulsive disorder are randomly assigned to two intervention programs (spiritual psychotherapy, cognitive-behavioral therapy). Cognitive-behavioral therapy protocol is presented for 15 clients with obsessive-compulsive disorder  in the twelve 90-minute group sessions, two sessions per week, by a psychotherapist who is proficient in cognitive-behavioral therapy.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Salmanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychiatry and Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Ave, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1333715914</zip>
        <telephone>+98 21 5541 3540</telephone>
        <email>m-salmanian@alumnus.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Salmanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychiatry and Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Ave, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1333715914</zip>
        <telephone>+98 21 5541 3540</telephone>
        <email>m-salmanian@alumnus.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. the age range of participants between 18 to 60. 2. Receiving OCD diagnosis based on diagnostic criteria of DSM-V by a psychiatrist. 3. do not have comorbid disorders such as bipolar disorder, psychosis, pervasive developmental disorder, mental retardation, and substance abuse. 4. do not have systemic disorders including cardiovascular disease. 5. not using psychiatric medications during one month ago. 6. not using drug or alcohol during one month ago. 7. did not commit suicide. 8. Being literate.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. Failure to receive a diagnosis of OCD by a psychiatrist. 2. clients aged less than 18 or more than 60 years. 3. having comorbid disorders. 4. having systemic disorders. 5. used psychiatric medications during one month ago. 6. used drug or alcohol during one month ago. 7. Having a history of suicide attempts. 8. Being illiterate</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: In this study, firstly the Spiritual Psychotherapy package is designed for people with OCD, then face and content validity is also evaluated using focus group discussions with experts. 30 clients with obsessive-compulsive disorder are randomly assigned to two intervention programs (spiritual psychotherapy, cognitive-behavioral therapy). The spiritual psychotherapy package is presented in twelve 90-minute group sessions, two sessions per week, for 15 clients with OCD, by a familiar spiritual psychotherapist who is proficient in performing the spiritual psychotherapy package. Spiritual psychotherapy sessions include: Familiarity with the treatment framework and obsessive-compulsive disorder. Realization and analysis of obsessive beliefs. Responsibility. Flexibility and quitting habits. Targeting. Forgiveness. Love of self. Love of others, work and belongings. Belief in sacred. Spiritual awareness, belief in transformation and change of religious obsessions. Prepare for the end and prevent recurrence.</i_keyword>
      <i_keyword>Intervention group: 30 clients with obsessive-compulsive disorder are randomly assigned to two intervention programs (spiritual psychotherapy, cognitive-behavioral therapy). Cognitive-behavioral therapy protocol is presented for 15 clients with obsessive-compulsive disorder  in the twelve 90-minute group sessions, two sessions per week, by a psychotherapist who is proficient in cognitive-behavioral therapy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Obsessive–compulsive disorder (OCD) symptoms. Timepoint: before and after intervention, and 3 months after the intervention. Method of measurement: The Yale–Brown Obsessive Compulsive Scale (Y-BOCS).</prim_outcome>
      <prim_outcome>The scores of thought-moral action, thought-action-probability action for others, thought-action-probability action for self. Timepoint: before and after intervention, and 3 months after the intervention. Method of measurement: Thought–action fusion (TAF).</prim_outcome>
      <prim_outcome>The scores of sense of responsibility / overestimation of risk, perfectionism / inability to tolerate uncertainty, importance / control of thoughts. Timepoint: before and after intervention, and 3 months after the intervention. Method of measurement: Obsessive beliefs 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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-21</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Psychiatry and Psychology Research Center, Roozbeh Hospital, South Kargar Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
