<?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>IRCT20220203053924N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-10</date_registration>
      <primary_sponsor>Allameh Tabataba'i University</primary_sponsor>
      <public_title>Effectiveness of Mindfulness-Based Cognitive Therapy on Anxiety and Burnout of Treatment Staff That Exposed to COVID_19</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Mindfulness-Based Cognitive Therapy on Anxiety and Burnout of Treatment Staff That Exposed to Covid_19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62285</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The study will be performed with two groups of control and experimental, pre-test will be taken from both groups and then treatment will be performed for the control group. A post-test will be performed after treatment and a post-test will be performed at intervals. At the end of the study, treatment will be performed for the control group, Randomization description: Sampling will be done voluntarily, but the subjects will be assigned to the experimental and control groups randomly and by drawing lots with a random number table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Covid-19 disease.</hc_freetext>
      <i_freetext>Intervention 1: Mindfulness-based cognitive therapy, according to Rebecca Crane's instructions, will be performed in eight one-hour sessions (one session per week) in a virtual and group setting. This therapy revolves around mindfulness exercises and being here and now and paying full attention to what is going on inside or outside the person; is. All relevant mindfulness techniques are taught in each session and subjects are asked to apply the techniques to learn properly. Between treatment sessions, subjects are given home exercises that will help stabilize the treatment. All questions and ambiguities of the subjects will be answered in the intervals between sessions. Treatment will take about two months. Intervention 2: Control group:  No treatment is provided in the control group during the study. Only pre-tests and post-tests are taken (one after the intervention of the experimental group and the other two months apart). If the members of the control group wish, after the end of the research, mindfulness-based cognitive therapy will be performed in the same way as the presentation to the intervention group. That is, the treatment will be performed in eight one-hour sessions with home exercises and answering the subjects' questions.</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 The data file will not be shared, only the results of the research will be published.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Tahmasbi Abdar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Allameh Tabataba'i University, The intersection of the Olympic Village, The West Shahid Hemmat Highway, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1489684511</zip>
        <telephone>+98 21 4839 0000</telephone>
        <email>faribatahmasbi2020@gmail.com</email>
        <affiliation>Allameh Tabataba'i University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Tahmasbi Abdar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Allameh Tabataba'i University, The intersection of the Olympic Village, The West Shahid Hemmat Highway, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1489684511</zip>
        <telephone>+98 21 4839 0000</telephone>
        <email>faribatahmasbi2020@gmail.com</email>
        <affiliation>Allameh Tabata'i University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Subjects should be medical staff who have been in contact with COVID_19 disease.
A score higher than fifteen in the Beck Anxiety Inventory</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Subjects undergoing psychological treatment or medication to reduce anxiety or burnout will be excluded from the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>covid-19, virus identified</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>Mindfulness-based cognitive therapy, according to Rebecca Crane's instructions, will be performed in eight one-hour sessions (one session per week) in a virtual and group setting. This therapy revolves around mindfulness exercises and being here and now and paying full attention to what is going on inside or outside the person; is. All relevant mindfulness techniques are taught in each session and subjects are asked to apply the techniques to learn properly. Between treatment sessions, subjects are given home exercises that will help stabilize the treatment. All questions and ambiguities of the subjects will be answered in the intervals between sessions. Treatment will take about two months.</i_keyword>
      <i_keyword>Control group:  No treatment is provided in the control group during the study. Only pre-tests and post-tests are taken (one after the intervention of the experimental group and the other two months apart). If the members of the control group wish, after the end of the research, mindfulness-based cognitive therapy will be performed in the same way as the presentation to the intervention group. That is, the treatment will be performed in eight one-hour sessions with home exercises and answering the subjects' questions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Beck anxiety score. Timepoint: Before the intervention, immediately after the intervention, two months after the end of the intervention. Method of measurement: Beck Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>Maslach burnout score. Timepoint: Before the intervention, immediately after the intervention, two months after the end of the intervention. Method of measurement: Maslach Burnout Questionnaire.</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>Allameh Tabataba'i University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-09</approval_date>
        <contact_name>Ethics Committee in Biomedical Research Allameh Tabatabai University</contact_name>
        <contact_address>Allameh Tabatabai University, Intersection of Olympic Village, The west Shahid Hemmat Highway., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
