<?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>IRCT20221214056812N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-04</date_registration>
      <primary_sponsor>Bu_Ali Sina University</primary_sponsor>
      <public_title>The effectiveness of emotion regulation therapy on symptoms people with social anxiety disorder comorbid with generalized anxiety disorder</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of emotion regulation therapy on decentering, difficulty in emotion regulation and symptoms people with social anxiety disorder comorbid with generalized anxiety disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67405</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this research, a simple random method will be used, in this way, the names of the volunteers will be placed in an envelope, and the names of 15 people will be randomly drawn, and these will be the intervention group, and the rest will be the control group, Blinding description: None of the sampled people will know about randomization and the process of allocation to groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Social Anxiety Disorder comorbid with General Anxiety Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: They receive 8 sessions of emotional regulation group therapy, each session of 90 minutes and on a weekly basis. Intervention 2: Control group: without therapy.</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:
Only data related to the final result is accessible

When:
Six months after the results are published

To whom:
Psychologist and psychiatrist researchers and experts

Conditions:
The use of documents is allowed only for further research

Where to obtain:
Soodeh Shadkam , Email: sshadkam5@gmail.com

How to obtain:
Send an email to the researcher

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soodeh shadkam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Hamadan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۸-۳۸۶۹۵</zip>
        <telephone>+98 81 3838 1601</telephone>
        <email>sshadkam5@gmail.com</email>
        <affiliation>Bu-Ali Sina University of Hamadan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soodeh Shadkam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Faculty of Economics, Department of Psychology</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۸-۳۸۶۹۵</zip>
        <telephone>+98 81 3838 1601</telephone>
        <email>sshadkam5@gmail.com</email>
        <affiliation>Bu-Ali Sina University of Hamadan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of SAD comorbid with GAD</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: They receive 8 sessions of emotional regulation group therapy, each session of 90 minutes and on a weekly basis.</i_keyword>
      <i_keyword>Control group: without therapy</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Symptoms of social anxiety disorder. Timepoint: Pre-test, post-test. Method of measurement: Social interaction anxiety scale.</prim_outcome>
      <prim_outcome>Symptom of general anxirty disorder. Timepoint: Pre-test, post-test. Method of measurement: General anxirty disorder scale-7.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety general distress. Timepoint: Pre-test, post-test. Method of measurement: Mind and anxiety symptom questionnaire (short form).</sec_outcome>
      <sec_outcome>Anxiety arousal. Timepoint: Pre test, post test. Method of measurement: Mind and anxiety symptom questionnaire (short form).</sec_outcome>
      <sec_outcome>Worry. Timepoint: Pre test, post test. Method of measurement: Penn state worry questionnaire.</sec_outcome>
      <sec_outcome>Negative repetitive thinking. Timepoint: Pre test, post test. Method of measurement: Perseverative thinking questionnaire.</sec_outcome>
      <sec_outcome>Decentering. Timepoint: Pre test, post test. Method of measurement: Experiences questionnaire.</sec_outcome>
      <sec_outcome>Difficulty in emotion regulation. Timepoint: Pre test, post test. Method of measurement: Difficulties in emotion regulation scale.</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>Bu_Ali Sina University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-13</approval_date>
        <contact_name>The ethics committee of Bu-Ali Sina University</contact_name>
        <contact_address>Bu-Ali Sina university of Hamadan, Chaharbagh Shahid Mostafa Ahmadi Roshan, Hamadan Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
