<?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>IRCT20181022041421N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-19</date_registration>
      <primary_sponsor>Torbate-Heidaria University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of DBT and MBCT on reduction of anxiety disorder and conversion disorder comparing dialectical therapy and mindfulness on reduction of anxiety disorder and conversion disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparative of dialectic therapy and mindfulness-based cognitive therapy (MBCT) on reduction of anxiety disorder and conversion disorder in patients with heart-like symptoms</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64933</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: First, based on inclusion and exclusion criteria, the subjects will be selected by available sampling and then the researcher will give each person a special code or number and the subjects will be placed in three groups through simple random sampling using random numbers table.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Condition 1: Anxiety disorder. Condition 2: Conversion disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1:                                                Dialectical behavior is a method based on four components of mind awareness, dyslexia tolerance, emotional regulation and interpersonal efficacy and can reduce the suffering of people involved in problems of disease anxiety and conversion disorder. One of the main skills of dialectical behavioral is emotion regulation skills that can improve mental disorders such as anxiety, conversion disorder, depression. Implementation of this intervention by training sessions based on the content of Linhan protocol including: 1.Emotion dominance 2.Reduction of physical and cognitive vulnerability 3.Increase in positive emotions 4.Lack of judgment 5.Problem solving 6.Feedback will be held for 8 sessions 90 minutes two sessions per week. Intervention 2: Intervention Group 2:                                            Mindfulness-based therapy is a method that focuses on the present in a purposeful and judgment-free manner. The main part of mindfulness focuses on mindfulness training and its applications in coping with anxiety, conversion disorders and pain. Mindfulness has shown some successes in improving quality of life, resilience, reducing anxiety, acquiring self-control skills, and emotional regulation. The implementation of this intervention will be conducted by training sessions based on the content of Crane's treatment protocol including: 1.acceptance 2. Living at the moment 3.Creating a good sense 4.Cognitive dissociation strategies 5.Clarification of values 6.Committed action will be held for 8 sessions of 90 minutes two sessions per week. Intervention 3: Control group: No intervention is received.</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 We're just going to publish the article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas Ghodrati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Street, Ferdowsi Boulevard</address>
        <city>Torbat Heydariyeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4456783456</zip>
        <telephone>+98 51 5222 6015</telephone>
        <email>ghodratita171@yahoo.com</email>
        <affiliation>Torbate-Heidaria University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbas Ghodrati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Street, Ferdowsi Boulevard</address>
        <city>تریت حیدریه</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5567897654</zip>
        <telephone>+98 51 5222 6015</telephone>
        <email>ghodratita171@yahoo.com</email>
        <affiliation>Torbate-Heidaria University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Lack of cardiac symptoms based on the diagnosis of a cardiologist, high score of conversion disorders and anxiety of the disease, Not participating in other treatment programs at the same time</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not receiving individual counseling, not receiving psychotherapy drugs during study, unwillingness to participate in research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
      <hc_code>F44</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
      <hc_keyword>Dissociative and conversion disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1:                                                Dialectical behavior is a method based on four components of mind awareness, dyslexia tolerance, emotional regulation and interpersonal efficacy and can reduce the suffering of people involved in problems of disease anxiety and conversion disorder. One of the main skills of dialectical behavioral is emotion regulation skills that can improve mental disorders such as anxiety, conversion disorder, depression. Implementation of this intervention by training sessions based on the content of Linhan protocol including: 1.Emotion dominance 2.Reduction of physical and cognitive vulnerability 3.Increase in positive emotions 4.Lack of judgment 5.Problem solving 6.Feedback will be held for 8 sessions 90 minutes two sessions per week.</i_keyword>
      <i_keyword>Intervention Group 2:                                            Mindfulness-based therapy is a method that focuses on the present in a purposeful and judgment-free manner. The main part of mindfulness focuses on mindfulness training and its applications in coping with anxiety, conversion disorders and pain. Mindfulness has shown some successes in improving quality of life, resilience, reducing anxiety, acquiring self-control skills, and emotional regulation. The implementation of this intervention will be conducted by training sessions based on the content of Crane's treatment protocol including: 1.acceptance 2. Living at the moment 3.Creating a good sense 4.Cognitive dissociation strategies 5.Clarification of values 6.Committed action will be held for 8 sessions of 90 minutes two sessions per week.</i_keyword>
      <i_keyword>Control group: No intervention is received.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety of the disease. Timepoint: 3 months. Method of measurement: Attitude to Disease Scale.</prim_outcome>
      <prim_outcome>Conversion disorder. Timepoint: 3 months. Method of measurement: Mental Disorder Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety disorder, developmental disorder. Timepoint: 3 months. Method of measurement: Attitude to Disease Scale  and Mental Disorder 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>Torbate-Heidaria University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-24</approval_date>
        <contact_name>Torbat Heydariyeh University of Medical Sciences</contact_name>
        <contact_address>Razi Ave, Ferdowsi Blvd Torbat Heydariyeh Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
