<?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>IRCT20220420054593N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-15</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the effectiveness of metacognitive therapy and Barlow meta-diagnosis in cognitive emotion regulation, experiential avoidance and reduction of clinical symptoms in the treatment of patients with anxiety disorder</public_title>
      <acronym>gad</acronym>
      <scientific_title>Comparison of the effectiveness of metacognitive therapy and Barlow meta-diagnosis in cognitive emotion regulation, experiential avoidance and reduction of clinical symptoms in the treatment of patients with anxiety disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63076</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>generalized anxiety disorder.</hc_freetext>
      <i_freetext>Intervention group: The effectiveness of Barlow metacognitive therapy and meta-diagnostic therapy in cognitive emotion regulation, experiential avoidance and reduction of clinical symptoms in the treatment of patients with generalized anxiety disorder. The independent variables in this study are Barlow metacognitive therapy and meta-diagnostic therapy and the dependent variables are emotion regulation, experimental avoidance and pervasive anxiety..</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 In order to benefit professors and students from the research</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali Square, next to the vehicle of Quds province, Mashhad, Iran</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8313491959</zip>
        <telephone>+98 51 3711 2709</telephone>
        <email>taheriem@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossien Sherafati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 25, Shahid Khoshnoodi 12, Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9133714165</zip>
        <telephone>+98 51 3256 6716</telephone>
        <email>sherafati.psy@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The research method is quasi-experimental with pre-test and post-test design and the statistical population of the study included patients with clinical symptoms of generalized anxiety disorder who referred to counseling and psychological clinics in Mashhad.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The effectiveness of Barlow metacognitive therapy and meta-diagnostic therapy in cognitive emotion regulation, experiential avoidance and reduction of clinical symptoms in the treatment of patients with generalized anxiety disorder. The independent variables in this study are Barlow metacognitive therapy and meta-diagnostic therapy and the dependent variables are emotion regulation, experimental avoidance and pervasive anxiety.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Generalized Anxiety Disorder In this study, Symptoms of Anxiety Disorders Using the Adult Version of the Anxiety Disorders Interview Program for DSM-5 (ADIS-5) Brown &amp; Barlow, 2014), Adult Version of the Pediatric Anxiety Disorders Screening Questionnaire (SCARED) -A) Van Steinsel Weblogs, 2014); The Beck Anxiety Inventory (Beck, Epstein, Brown, &amp; Steer, 1993), the Social Interaction Anxiety Scale (SIAS; Metic &amp; Clark, 1998), and the Comprehensive Anxiety Disorder Short Scale (Spitzer, Kronki, Williams, &amp; Brand, 2006) are measured. Timepoint: Anxiety questionnaires are collected from clients in the first week of treatment and in the following weeks every two weeks. Method of measurement: Anxiety Assessment Questionnaires.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Emotion regulation: is the score that a person obtains in the difficult questionnaire in emotion regulation Graz and Roemer (2004). Timepoint: The first week and once every two weeks. Method of measurement: emotion regulation Graz and Roemer.</sec_outcome>
      <sec_outcome>Experimental Avoidance: The score that a person obtains in the Experiential Avoidance Questionnaire of the Acceptance and Editing Practice Questionnaire (AAQ-II). Timepoint: The first week and once every two weeks in subsequent weeks. Method of measurement: the Acceptance and Editing Practice Questionnaire (AAQ-II).</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>Islamic Azad University of Bojnourd</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-06</approval_date>
        <contact_name>Ethics Committees of Islamic Azad University,Bojnourd Branch</contact_name>
        <contact_address>Imam Khomeini St, General Department of Education of Khorasan Razavi, MashhadTown mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
