<?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>IRCT20190518043626N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-23</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>Comparing The Efficacy Of Metacognitive Group Therapy And Cognitive - Behavioral GroupTherapy On Reducing Of The Symptoms And Metacognitive Factors Of Social Anxiety Disorder In Students.</public_title>
      <acronym>CBT &amp; MCT</acronym>
      <scientific_title>Comparing The Efficacy Of Metacognitive Group Therapy And Cognitive - Behavioral GroupTherapy On Reducing Of The Symptoms And Metacognitive Factors Of Social Anxiety Disorder In Students:Double Blind Randomized Clinical Trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39646</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After diagnosis by a specialist, patients are assigned to treatment groups 1, 2, and control group, regardless of their specific characteristics, by software, so that all participants have the odds of being in groups, Blinding description: After selecting a sample, none of the sample individuals will know about the randomization process and allocation process to the groups. The data analyst is selected outside of the study, and all data will be encoded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>social anxiety disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Cognitive-behavioral group therapy Based on Hoffman model. Intervention 2: Intervention group:Metacognitive group therapy. Intervention 3: Control group:No intervention.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All information about the original outcome will be published with the likes of it.

When:
Get started since 1400.

To whom:
Researchers working in academia.

Conditions:
Access to the documentation is possible for other researchers.
Access to the documentation is possible with the researcher.

Where to obtain:
Shaheed Beheshti Hospital, Zanjan, Department of Clinical Psychology, Dr. Saeedeh Zooszian. Tel: 09032180053 Zanjan Shahid Beheshti Hospital, Department of Clinical Psychology, Fatemeh Rezaei Khodadadi.  Tel: 09130514827

How to obtain:
The required documentation will be shared only by mentioning the reason for the request by email or telephone.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeedeh Zenoozian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Crossroads of Saadi, Gate of the Citadel, Shahid Beheshti Hospital</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>45136-15788</zip>
        <telephone>+98 24 3354 2403</telephone>
        <email>Zenoozian@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Rezaei Khodadadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Crossroads of Saadi, Gate of the Citadel, Shahid Beheshti Hospital.</address>
        <city>Zanjan.</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>45136-15788</zip>
        <telephone>+98 24 3354 2403</telephone>
        <email>Fatma.Rezaei72@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Tendency to participate in research.
A score of between 21 and 40 (mild to moderate social anxiety) in SPIN.
Age of 18 years and older.
Residence in Zanjan city during research.
Being a student.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>At the same time receive psychological treatment.
Absence of more than two continuous sessions in therapeutic sessions.
Lack of participation in one of the three stages of evaluation.
History of psychosis, alcohol related disorders, bipolar disorder and personality disorders.
At the same time taking psychiatric medications.
Score 15 to 25 in BDI-II.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Social phobias</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Cognitive-behavioral group therapy Based on Hoffman model.</i_keyword>
      <i_keyword>Intervention group:Metacognitive group therapy.</i_keyword>
      <i_keyword>Control group:No intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Symptoms of Social Anxiety Disorder. Timepoint: Pre-test, post-test and follow-up (three months after the post-test). Method of measurement: Conver social phobia Questionnaire(SPIN) and social interaction anxiety scale(SIAS).</prim_outcome>
      <prim_outcome>Social phobia. Timepoint: Pre-test, post-test and follow-up (three months after the post-test). Method of measurement: Conver social phobia Questionnaire(SPIN).</prim_outcome>
      <prim_outcome>Social interaction. Timepoint: Pre-test, post-test and follow-up (three months after the post-test). Method of measurement: social interaction anxiety scale(SIAS).</prim_outcome>
      <prim_outcome>Fear of negative evaluation. Timepoint: Pre-test, post-test and follow-up (three months after the post-test). Method of measurement: Fear of negative evaluation of short form questionnaire(FNES-B).</prim_outcome>
      <prim_outcome>Cognitive-attentional syndrome. Timepoint: Pre-test, post-test and follow-up (three months after the post-test). Method of measurement: CAS-1.</prim_outcome>
      <prim_outcome>Negative metacognitive beliefs about risk and uncontrollability. Timepoint: Pre-test, post-test and follow-up (three months after the post-test). Method of measurement: MCQ-30.</prim_outcome>
      <prim_outcome>Positive metacognitive beliefs about worries. Timepoint: Pre-test, post-test and follow-up (three months after the post-test). Method of measurement: MCQ-30.</prim_outcome>
      <prim_outcome>Cognitive Confidence. Timepoint: Pre-test, post-test and follow-up (three months after the post-test). Method of measurement: MCQ-30.</prim_outcome>
      <prim_outcome>Cognitive self-awareness. Timepoint: Pre-test, post-test and follow-up (three months after the post-test). Method of measurement: MCQ-30.</prim_outcome>
      <prim_outcome>Need to control thought. Timepoint: Pre-test, post-test and follow-up (three months after the post-test). Method of measurement: MCQ-30.</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-15</approval_date>
        <contact_name>Ethics Committee of zanjan University of Medical Sciences</contact_name>
        <contact_address>Crossroads of Saadi, Gate of the Citadel, Shahid Beheshti Hospital Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
