<?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>IRCT20180421039369N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-30</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of eye movement desensitization and reprocessing on Improving Post-Traumatic Psychological Symptoms in Children and Adolescents, 6-18 Years Old, Surviving Earthquake</public_title>
      <acronym>EMDR</acronym>
      <scientific_title>The Effectiveness of eye movement desensitization and reprocessing on Improving Post-Traumatic Psychological Symptoms in Children and Adolescents, 6-18 Years Old, Surviving Earthquake</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41528</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After making the necessary adjustments among the referrals, 34 individuals will be selected by purposive sampling and then will be randomly assigned to number 1 and 2 individually (by hat), each code number of a group. Then 17 participants will be randomly assigned to the group receiving the EMDR (experimental group) intervention and 17 participants will be randomly assigned to the group that received the intervention protocol in the Ministry of Health (control group), Blinding description: Unilateral blinding will be performed by independent and trained evaluators who are two clinical psychology MA students without evaluating the type of intervention and treatment subjects.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Post traumatic psychological symptoms.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will receive desensitization treatment through eye movements and reprocessing. Eye movement desensitization and reprocessing (EMDR) is an eight-step information processing treatment that examine many empirical pathological factors. The past experiences are used as the fundamental basis in this treatment. It assesses pathology and examines present situations that trigger unpleasant emotions. Additionally, this treatment evaluates the positive beliefs, emotions and experiences needed for future mental health and normal behaviors. This treatment is a short-term trauma-based treatment approach for post-traumatic stress disorder, originally designed for PTSD. The main feature of this approach is that the patient keeps a distressing image of the trauma in mind while engaging in a series of involuntary eye movements. Intervention 2: The control group will receive the Crisis Intervention Protocol.</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>Sajjad Reisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 84 3442 3968</telephone>
        <email>sajjad.reisi@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sajjad Reisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 84 3442 3968</telephone>
        <email>sajjad.reisi@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having post-traumatic stress disorder (PTSD, depression, anxiety and behavioral problems)
Children and adolescents aged 6-18 years
Referred to psychological centers and hospitals for post-traumatic stress disorder
consent of the child, adolescents and their parents in the research
Fluent in Persian
Not Developing medical conditions that are simultaneously with post-traumatic stress disorder
Not Developing Symptoms of psychosis and delusions
Not Consuming Psychiatric drugs, and psychotropic substances, narcotics and alcohol</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Incomplete questionnaires
Failure to attend two or more counseling sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Post-traumatic stress disorder (PTSD)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group will receive desensitization treatment through eye movements and reprocessing. Eye movement desensitization and reprocessing (EMDR) is an eight-step information processing treatment that examine many empirical pathological factors. The past experiences are used as the fundamental basis in this treatment. It assesses pathology and examines present situations that trigger unpleasant emotions. Additionally, this treatment evaluates the positive beliefs, emotions and experiences needed for future mental health and normal behaviors. This treatment is a short-term trauma-based treatment approach for post-traumatic stress disorder, originally designed for PTSD. The main feature of this approach is that the patient keeps a distressing image of the trauma in mind while engaging in a series of involuntary eye movements.</i_keyword>
      <i_keyword>The control group will receive the Crisis Intervention Protocol.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post traumatic psychological symptoms. Timepoint: A week before the intervention, after the intervention, two months after the intervention. Method of measurement: Child Behavior Checklist (Achenbach)(ASEBA)/ Maria Kovas Depression Inventory (CDI)/ Revised Reynolds and Richmond Children's Anxiety Scale (RCMAS) /Trauma Symptoms Checklist for Children (TSCC-A) /PTSD Assessment Scale for Clinicians (CAPS-CA) / Anxiety and Depression Scale for Children (RCADS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Post Traumatic Stress Disorder (PTSD). Timepoint: A week before the intervention, after the intervention, two months after the intervention. Method of measurement: Trauma Symptoms Checklist for Children (TSCC-A) /PTSD Assessment Scale for Clinicians (CAPS -CA).</sec_outcome>
      <sec_outcome>Depression. Timepoint: A week before the intervention, after the intervention, two months after the intervention. Method of measurement: Maria Kovas Depression Inventory (CDI)/ Anxiety and Depression Scale for Children (RCADS).</sec_outcome>
      <sec_outcome>Anxiety. Timepoint: A week before the intervention, after the intervention, two months after the intervention. Method of measurement: Anxiety and Depression Scale for Children (RCADS) / Revised Reynolds and Richmond Children's Anxiety Scale (RCMAS).</sec_outcome>
      <sec_outcome>Behavioral problems. Timepoint: A week before the intervention, after the intervention, two months after the intervention. Method of measurement: Behavior Checklist (Achenbach)(ASEBA).</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-08</approval_date>
        <contact_name>Ethics Committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Central Building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd, Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
