<?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>IRCT20180421039369N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-13</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>A study of the effectiveness of transdiagnostic unified protocol on the treatment of posttraumatic stress disorder</public_title>
      <acronym></acronym>
      <scientific_title>A study of the effectiveness of transdiagnostic unified protocol on the treatment of posttraumatic stress disorder and comorbid symptoms in survivors of earthquake</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>33</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43242</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Post Traumatic Stress Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, Barlow's integrated, meta-diagnostic ultrasound treatment will be used. The sample included 33 individuals, divided randomly into two groups of experimental and control, with 11 subjects in the experimental group and 22 in the control group. A group will be provided individually for 12 sessions. The sessions consist of eight sections: Section 1) Increasing motivation to participate in therapy, Section 2) Psychological training and tracking of emotional experiences, Section 3) Emotional awareness training 4) Evaluating and modifying cognitive assessment, Section 5) Emotional avoidance Emotional behaviors, Section 6) Understanding Physical Emotions and Their Tolerance, Section 7) Exposure to External and Internal Emotions, Section 8) Preventing Recurrence. Intervention 2: Control group: Control group: control group consist of 22 people who are waiting in the waiting list and and do not receive treatment during the time of intervention.but after treatment ,they will receive ministry of health conventional treatment  for maintaining the ethics of the control group.</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 Ther is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid piri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isar Square at the begining of Dolat abad Hospital Farabi,Kermanshah</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6711594714</zip>
        <telephone>+98 83 3827 2949</telephone>
        <email>nahidpiri1989@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Piri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isar Square at the begining of Dolat abad Hospital Farabi,Kermanshah.</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6711591447</zip>
        <telephone>+98 83 3827 2949</telephone>
        <email>nahidpiri1989@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Minimum age 18 and maximum 40 yesrs
Minimum tertiary guidance education a person with post-traumatic stress disorder trauma after experiencing sarpole zahab earthquake as a diagnosis based on a psychologist
Motivation and lack of motivation to participate in treatment
No symptoms of disassociation.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Criteria exit :Psychotic and bipolar disorder,
uncontrollable flashback</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>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, Barlow's integrated, meta-diagnostic ultrasound treatment will be used. The sample included 33 individuals, divided randomly into two groups of experimental and control, with 11 subjects in the experimental group and 22 in the control group. A group will be provided individually for 12 sessions. The sessions consist of eight sections: Section 1) Increasing motivation to participate in therapy, Section 2) Psychological training and tracking of emotional experiences, Section 3) Emotional awareness training 4) Evaluating and modifying cognitive assessment, Section 5) Emotional avoidance Emotional behaviors, Section 6) Understanding Physical Emotions and Their Tolerance, Section 7) Exposure to External and Internal Emotions, Section 8) Preventing Recurrence</i_keyword>
      <i_keyword>Control group: Control group: control group consist of 22 people who are waiting in the waiting list and and do not receive treatment during the time of intervention.but after treatment ,they will receive ministry of health conventional treatment  for maintaining the ethics of the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Posttraumatic stress disorder. Timepoint: A week befor the intervention,one week after the intervention,Two months after the intervention. Method of measurement: Mississippi Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression. Timepoint: A week befor the intervention,one week after the intervention,Two months after the intervention. Method of measurement: Beck Depression Inventory(BDI-II).</sec_outcome>
      <sec_outcome>Anxiety. Timepoint: A week befor the intervention,one week after the intervention,Two months after the intervention. Method of measurement: ,Hamiton Rating Scale for Anxiety(HRSA).</sec_outcome>
      <sec_outcome>Quality of Life. Timepoint: A week befor the intervention,one week after the intervention,Two months after the intervention. Method of measurement: Ware &amp; Sherbourne Inventory,.</sec_outcome>
      <sec_outcome>Sleep Quality. Timepoint: A week befor the intervention,one week after the intervention,Two months after the intervention. Method of measurement: ,Pittsburgh Sleep Quality Index.</sec_outcome>
      <sec_outcome>Posttraumatic stress disorder. Timepoint: A week befor the intervention,one week after the intervention,Two months after the intervention. Method of measurement: Mississippi Scale.</sec_outcome>
      <sec_outcome>Social Adjustment. Timepoint: A week befor the intervention,one week after the intervention,Two months after the intervention. Method of measurement: Bell Adjustment Questionnaire.</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>2019-10-14</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>
