<?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>IRCT20211120053117N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-16</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>effectiveness of behavioral, emotional and spiritual therapy protocol on obsessive-compulsive symptoms</public_title>
      <acronym></acronym>
      <scientific_title>Developing and effectiveness of behavioral, emotional and spiritual therapy protocol on obsessive-compulsive symptoms, scrupulosity, fusion of thought and action and rumination in patients with OCD.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60112</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: Simple randomization, 40 people who meet the inclusion criteria are selected. They are then sorted by age and education and will be divided into experimental and control groups. Finally, it is assessed that the two groups are peer based on the variables of age, marriage, education, Blinding description: Participants are not aware that they are in the experimental or control group. The therapist also does not know. So the two heads are blind. But the researcher who collects and analyzes the data knows.</study_design>
      <phase>N/A</phase>
      <hc_freetext>obsessive-compulsive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: behavioral, emotional and spiritual therapy       The total treatment plan is 15 sessions of 90 minutes, the first 8 sessions are held in four weeks and the next 7 sessions are held once a week. The objectives of the sessions are: 1) Establishing a therapeutic relationship and explaining the disease cycle and the logic of treatment 2) Positive secondary spiritual evaluation of negative thoughts 3) Review and completion of positive secondary spiritual evaluation of negative thoughts 4) Accepting doubts 5) Self-relaxation training 6) Reducing thought fusion and Action 7) Mindfulness skills about negative thoughts and feelings 8) Facing and refraining from responding 9) Accepting doubts and managing behavior in practical obsession 10) Regulating emotion to reduce vulnerability 11) Mindfulness skills mixed with spirituality 12) Removing barriers In the hierarchy of exposure and inhibition of response 13) removal of barriers to exposure and inhibition of response 14) increase in quality of life 15) prevention of recurrence and lifestyle modification. In order to achieve these goals, behavioral therapy techniques and mindfulness, acceptance and commitment therapy techniques are used. Intervention 2: Control group: During the intervention in the experimental group, they do not receive treatment and wait in line, and after the intervention in the experimental group, they receive the treatment due to the research ethics.</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:
All participants' information is shared by deleting their names.

When:
Access period starts one year after the results are published

To whom:
Only faculty members in the field of psychology

Conditions:
Meta-analysis is allowed

Where to obtain:
Email farhoush.mohammad@gmail.com and request

How to obtain:
Finally, the data will be sent one week after the request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mohammad farhoush</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 27, Aftab Complex, Alley 5, Shahid Ghodoosi St., 75 meters Amaryasar, Qom, Iran</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3719159697</zip>
        <telephone>+98 25 3778 0659</telephone>
        <email>farhoush.mohammad@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mohammad farhoush</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 27, Aftab Complex, Alley, Shahid Ghodoosi St.,75 meters Amaryasar, Qom, Iran</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3719159697</zip>
        <telephone>+98 25 3778 0659</telephone>
        <email>farhoush.mohammad@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>gender Man
Diagnosis of obsessive-compulsive disorder based on a structured clinical interview based on the DSM-5 conducted by a specialist psychologist and also a person with a score of more than 10 on the Yale Brown Obsessive Questionnaire.
The person has obsessive-compulsive disorder (obsessive-compulsive disorder and compulsive behavior ‌ have both)
The person has a history of obsession for at least six months and a maximum of 5 years
The age of the person is 18 to 40 years
Diploma level higher
Be prepared and satisfied to attend all treatment sessions.
Complete all research questionnaires.
Volunteer to treat obsessive-compulsive disorder.
Has not received treatment for obsessive-compulsive disorder in the last trimester.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Mental Retardation, Psychotic Disorders, Type 1 Bipolar Disorder, Severe Personality Disorder, Severe Depressive Disorder, Substance Abuse Disorder
Receive concurrent psychological interventions.
Receive medication intervention simultaneously.</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: behavioral, emotional and spiritual therapy       The total treatment plan is 15 sessions of 90 minutes, the first 8 sessions are held in four weeks and the next 7 sessions are held once a week. The objectives of the sessions are: 1) Establishing a therapeutic relationship and explaining the disease cycle and the logic of treatment 2) Positive secondary spiritual evaluation of negative thoughts 3) Review and completion of positive secondary spiritual evaluation of negative thoughts 4) Accepting doubts 5) Self-relaxation training 6) Reducing thought fusion and Action 7) Mindfulness skills about negative thoughts and feelings 8) Facing and refraining from responding 9) Accepting doubts and managing behavior in practical obsession 10) Regulating emotion to reduce vulnerability 11) Mindfulness skills mixed with spirituality 12) Removing barriers In the hierarchy of exposure and inhibition of response 13) removal of barriers to exposure and inhibition of response 14) increase in quality of life 15) prevention of recurrence and lifestyle modification. In order to achieve these goals, behavioral therapy techniques and mindfulness, acceptance and commitment therapy techniques are used.</i_keyword>
      <i_keyword>Control group: During the intervention in the experimental group, they do not receive treatment and wait in line, and after the intervention in the experimental group, they receive the treatment due to the research ethics.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Obsessive-compulsive symptoms. Timepoint: Before the intervention and after the intervention. Method of measurement: Yale Brown Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Rumination. Timepoint: Before and after the intervention. Method of measurement: rumination questionnaire.</sec_outcome>
      <sec_outcome>Scrupulosity. Timepoint: Before and after the intervention. Method of measurement: peen inventory of scrupulosity.</sec_outcome>
      <sec_outcome>Obsessive beliefs. Timepoint: Before and after the intervention. Method of measurement: obsessive beliefs questionnarie.</sec_outcome>
      <sec_outcome>Fusion of thought and action. Timepoint: Before and after the intervention. Method of measurement: thought fusion instrument.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-27</approval_date>
        <contact_name>Research Ethics Committees of Semnan University of Medical Sciences and Health services</contact_name>
        <contact_address>Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran. semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
