<?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>IRCT20200411047023N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-26</date_registration>
      <primary_sponsor>Golestan University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effectiveness of online Balint group and SSRIs in Coronavirus anxiety</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of online Balint group and pharmacotherapy with Selective Serotonin Reuptake Inhibitors in Coronavirus anxiety in healthcare workers.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53441</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects will be allocated according to the order of enrollment. The first patient to fulfill the inclusion criteria will be assigned to the Balint group, the second patient to the pharmacotherapy group, and the allocation will be continued in this way.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Illness anxiety disorder.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention group: Participating in 5 to 10 session of Online Balint Group. Intervention 2: Second Intervention group: Standard pharmacological treatment with a drug from Selective Serotonin Reuptake Inhibitors (SSRIs) started from low-dose and increased if needed during follow-up.</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:
After issuing appropriate permission from Golestan University of Medical Sciences all recorded data can be shared anonymously.

When:
6 months after publishing the results of the study in research journals.

To whom:
All the researchers and scientific institutes can access our data.

Conditions:
All the researchers and scientific institutes should mention why and how they want to use the data in their request. Moreover, distributing further results needs new permission from the corresponding person.

Where to obtain:
Written formal requests should be emailed to Dr. Najmeh Shahini using the below email address:
Najmeh.shahini@gmail.com
5th Azar Hospital, 5th Azar St., Gorgan, Iran
Phone Number: 00981731153365

How to obtain:
After receiving formal data access requests, it should be evaluated and approved by the research team and deputy of research at Golestan University of Medical Sciences.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Najmeh Shahini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th Azar Hospital, 5th Azar St.</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4917763681</zip>
        <telephone>+98 17 3115 3365</telephone>
        <email>Najmeh.shahini@gmail.com</email>
        <affiliation>Golestan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Najmeh Shahini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th Azar Hospital, 5th Azar St.</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4917763681</zip>
        <telephone>+98 17 3115 3365</telephone>
        <email>Najmeh.shahini@gmail.com</email>
        <affiliation>Golestan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Hospital Healthcare workers who have been in contact with COVID-19 patients
No history of previous psychiatric illness
Ability to use Skype application and participate in online sessions
Written consent for participating in the study
Diagnosis of illness anxiety after being evaluated by two psychiatrists</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>59 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No further interest in continuing the study
More than 3 absent Balint sessions
No medication compliance</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other anxiety disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First Intervention group: Participating in 5 to 10 session of Online Balint Group</i_keyword>
      <i_keyword>Second Intervention group: Standard pharmacological treatment with a drug from Selective Serotonin Reuptake Inhibitors (SSRIs) started from low-dose and increased if needed during follow-up</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score in Corona Disease Anxiety Scale (CDAS). Timepoint: At the beginning of study (before intervention) and after 4 weeks. Method of measurement: Corona Disease Anxiety Scale (CDAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Score in Connor-Davidson resilience scale. Timepoint: At the beginning of study (before intervention) and after 4 weeks. Method of measurement: Connor-Davidson resilience 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>Golestan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-18</approval_date>
        <contact_name>Ethics committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Ethics Committee office, Deputy of research and technology of Golestan University of Medical Sciences, Central Library building, beginning of Shast-Kala road Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
