<?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>IRCT20190822044581N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-25</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Eye Movement Desensitization and Reprocessing(EMDR) as a treatment for Rape victims</public_title>
      <acronym></acronym>
      <scientific_title>Eye Movement Desensitization and Reprocessing(EMDR) as a treatment for Rape victims</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50388</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be randomly assigned between the two groups. During the random block assignment, the order of the participants in the intervention and control groups is as follows: by multiplying the number of study groups (two groups) by 2, the number of samples in each Block 4 will be calculated.
Then, by calculating the factorial of each sample block (4 = 4 = 4 3 × 2 24 1 = 24), the number of blocks created from all possible orders will be obtained as 24. Since the number of people in each block is 4 people And the estimated sample size will be based on the description of 60 people, by matching 13 random numbers produced by Sample Randomizer with the mentioned block numbers, the order of 60 people will be determined. Number one to sixty to the subject groups And controls are assigned and the random assignment list will be edited.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Suicidal thoughts.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the first session, the patient's medical history and information were collected in a safe place. The EMDR process is explained to the patient and the annoying scene of the rape is identified for the patient. For each patient, the standard EMDR treatment method will be performed individually in a safe environment and the number of sessions between 6 sessions to 8 90-minute sessions will be held by a psychologist and researcher. After the end of the treatment interventions, the above questionnaires will be collected again by the patients and the researcher. Patients will not be prohibited from their medication and will receive the medications prescribed by their treating physician. And only the method of desensitization with eye movements and reprocessing as a method of psychotherapy will be performed on the experimental group. Intervention 2: Control group: In this group, no intervention will be performed by the researcher and they will only receive routine hospital treatments.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Naeem Abdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yasuj - Shahid Motahari Boulevard - Yasuj University of Medical Sciences</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591994799</zip>
        <telephone>+98 74 3333 7230</telephone>
        <email>abdi.naeim@yahoo.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Naeem Abdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yasuj - Shahid Motahari Boulevard - Yasuj University of Medical Sciences</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591994799</zip>
        <telephone>+98 74 3333 7230</telephone>
        <email>abdi.naeim@yahoo.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who have been raped in the past
Patients have been hospitalized with a diagnosis of major depressive disorder
Has a moderate to high suicidal ideation score (score 5 or higher)
Have criteria for post-traumatic stress disorder based on the DSMIV scale</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People who are not satisfied with the intervention are considered as a control group.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the first session, the patient's medical history and information were collected in a safe place. The EMDR process is explained to the patient and the annoying scene of the rape is identified for the patient. For each patient, the standard EMDR treatment method will be performed individually in a safe environment and the number of sessions between 6 sessions to 8 90-minute sessions will be held by a psychologist and researcher. After the end of the treatment interventions, the above questionnaires will be collected again by the patients and the researcher. Patients will not be prohibited from their medication and will receive the medications prescribed by their treating physician. And only the method of desensitization with eye movements and reprocessing as a method of psychotherapy will be performed on the experimental group.</i_keyword>
      <i_keyword>Control group: In this group, no intervention will be performed by the researcher and they will only receive routine hospital treatments</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Suicidal ideation: Beck suicidal ideation questionnaire will be used to assess suicidal ideation. The Beck Suicide Thought Scale is a 19-item tool. This questionnaire was developed to identify and measure the severity of attitudes, behaviors, and planning for suicide during the past week. The scale is set based on three point degrees from 0 to 2. The person's total score is calculated based on the sum of scores, which is from 0 to 38, and in this test, the higher the person's score, the higher his suicidal thoughts. Timepoint: Before and after the intervention. Method of measurement: Beck Suicide Thought Questionnaire will be used to assess suicidal ideation. The Beck Suicide Thought Scale is a 19-item tool. This questionnaire was developed to identify and measure the severity of attitudes, behaviors, and planning for suicide during the past week. The scale is set based on three point degrees from 0 to 2. The person's total score is calculated based on the sum of scores, which is from 0 to 38, and in this test, the higher the person's score, the higher his suicidal thoughts.</prim_outcome>
      <prim_outcome>Subjective Distress: This scale, which is one of the self-reporting scales, was introduced by Wolfe. The range of scores can be graded on a 101-point scale between zero and 100 or on an 11-point scale between zero and 10. The person evaluates and reports the degree of discomfort at each stage and at the request of the therapist or researcher. Obviously, zero here means no mental distress and a score of 10 indicates the maximum amount of mental distress. Timepoint: This questionnaire is completed by the patient and the researcher before and after each treatment session. Method of measurement: This scale, which is one of the self-reporting scales, was introduced by Wolfe. The range of scores can be graded on a 101-point scale between zero and 100 or on an 11-point scale between zero and 10. The person evaluates and reports the degree of discomfort at each stage and at the request of the therapist or researcher. Obviously, zero here means no mental distress and a score of 10 indicates the maximum amount of mental distress.</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>Vice Chancellor for Research, Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-08</approval_date>
        <contact_name>Yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj - Shahid Motahari Boulevard - Yasuj University of Medical Sciences YASUJ Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
