<?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>IRCT20190724044326N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-05</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The assessment of group metacognitive  therapy on Patients with post-traumatic stress disorde</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of group metacognitive therapy on Patients with post-traumatic stress disorder due to earthquake in Kermanshah</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41632</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomizing assignment, the Simple Random method is used. 45 cards with the same appearance are provided. On 15 of cards the number 1 and on 30 of them the number 2 is written which represent the intervention group and the control group respectively. Then, one card is given to each qualified individual randomly and his assignment to the group is recorded. This process is continues until all individuals are assigned. It should be noted that participants are unaware of the nature of the numbers and type of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Post Traumatic Stress Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, Wells' metacognitive therapy for anxiety disorders  will be used. .The sample size in this study is 45. They are randomly divided into two experimental and control groups, in which 15 subjects in the experimental group and 30 in the control group are placed and the treatment plan will be available in a group for 10 sessions.The contents of the group meta_cognitive therapy sessions are: The first session)Including referrals, Introducing ptsd disorder, Check ptsd symptoms  second session) Introducing Metacognitive Therapy, Model introduction and preparation  third session) Analysis of Metacognitive Positive and Negative Beliefs and Meta_cognitive Control Strategies fourth Session) Introduce Cognitive Attentional Syndrome to patients, a type of repetitive thinking that is a concern or rumination focused on threat and maladaptive behaviors (such as thought suppression, avoidance, substance use). Fifth Session) Technique of attention training, technique logic, technique validation Sixth Session) Applying Mindfulness Techniques to Breakthrough Seventh Session) Four of the ten mindfulness techniques were taught to the participants Eighth Session) Teaching the other three techniques of the ten mindfulness techniques Ninth Session) The remaining three techniques are taught to the participants Tenth Session) Prepare members for closure. Intervention 2: Control group: Control group: Control group: consists of 30 people who are waiting in the waiting list and do not receive treatment during the time of intervention. but after treatment, they will receive several sessions of  meta_cognitive group therapy 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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>sasan amiri</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>sasanamiri2910@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>sasan amiri</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>sasanamiri2910@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Suffering PTSD disorder with diagnosis of psychiatrist and clinical psychologist
the individual's ability to attend a therapeutic session
The age range is between 50 to 18 years old
Affliction of PTSD disorder and having emotional symptoms including depression, anxiety based on diagnostic interview by psychologist
Motivation and satisfaction for participation during treatment
Failure to receive psychological treatment in the past year
Have at least a cycle of education
Not having a history of sexual abuse
Not having other chronic diseases such as severe liver disorder
The lack of current diagnosis of any mental disorder is consistent in Diagram 1 and 2 based on a psychologist's diagnostic interview, with the exception of PTSD disorder and emotional disorders including depression, anxiety
No obvious risk of suicide now
There is no history of drug abuse or dependence at the current time and within one year before the start of treatment</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to attend research meetings
ot attending at least 50% of the sessions
Creating severe physical problems so that it can not be present at meetings</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: In this study, Wells' metacognitive therapy for anxiety disorders  will be used. .The sample size in this study is 45. They are randomly divided into two experimental and control groups, in which 15 subjects in the experimental group and 30 in the control group are placed and the treatment plan will be available in a group for 10 sessions.The contents of the group meta_cognitive therapy sessions are: The first session)Including referrals, Introducing ptsd disorder, Check ptsd symptoms  second session) Introducing Metacognitive Therapy, Model introduction and preparation  third session) Analysis of Metacognitive Positive and Negative Beliefs and Meta_cognitive Control Strategies fourth Session) Introduce Cognitive Attentional Syndrome to patients, a type of repetitive thinking that is a concern or rumination focused on threat and maladaptive behaviors (such as thought suppression, avoidance, substance use). Fifth Session) Technique of attention training, technique logic, technique validation Sixth Session) Applying Mindfulness Techniques to Breakthrough Seventh Session) Four of the ten mindfulness techniques were taught to the participants Eighth Session) Teaching the other three techniques of the ten mindfulness techniques Ninth Session) The remaining three techniques are taught to the participants Tenth Session) Prepare members for closure</i_keyword>
      <i_keyword>Control group: Control group: Control group: consists of 30 people who are waiting in the waiting list and do not receive treatment during the time of intervention. but after treatment, they will receive several sessions of  meta_cognitive group therapy maintaining the ethics of the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post Traumatic Stress Disorder. Timepoint: A week before the intervention, Mid-intervention, one week after the intervention, Three months after the intervention. Method of measurement: Beck Depression Inventory (BDI-II), Beck Anxiety Inventory and Post-traumatic Stress PTSD Checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression. Timepoint: A week before the intervention, Mid-intervention, one week after the intervention, three months after the intervention. Method of measurement: Beck Depression Inventory (BDI-II).</sec_outcome>
      <sec_outcome>Anxiety. Timepoint: A week before the intervention, Mid-intervention, one week after the intervention, three months after the intervention. Method of measurement: Beck Anxiety Inventory.</sec_outcome>
      <sec_outcome>Post-traumatic stress. Timepoint: A week before the intervention, Mid-intervention, one week after the intervention, three months after the intervention. Method of measurement: Post-traumatic Stress PTSD Checklist.</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>2019-08-17</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>
