<?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>IRCT20181120041707N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-23</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness Comparison of Metacognitive Counseling  in Virtual and Face To Face method on the Anxiety and Meta-worry of Women with Abortion History</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness Comparison of Metacognitive Counseling  in Virtual and Face To Face method on the Anxiety and Meta-worry of Women with Abortion History</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35643</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Women with a history of abortion who are eligible for inclusion in the study are divided into two groups of virtual counseling (20 in two groups of ten) and face-to-face counseling (20 in two groups of ten) using a randomized computer table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Abortion.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Virtual Consultation.Virtual consultancy is provided in multimedia and attractive format and one day a week by virtual method through installing one of the authorized Persian messaging software and having the ability to secure private space suitable for mobile phone research units, and from them You will be asked to submit your questions online and get help from the researcher. It is worth mentioning that for the purpose of providing Internet chat, the package is provided weekly and free of charge to the virtual intervention group by the researcher until the end of the study period. For this purpose, the mobile number of the research units will be designed by the researcher after receiving informed consent and the group will be designed to respond to the researcher. Regarding how to coordinate with research units, such as attending a group chat at the scheduled time, homework reminders, or the desire to have a private chat after the end of the chat group, the necessary information is provided by the researcher. Intervention 2: Intervention group: In-person counseling.Individuals under the group counseling protocol are included in eight 90-minute counseling sessions on meta-cognitive therapy advised by supervisors, psychologist, counselor, and observer.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ghiyasi Shahmabadi Mina</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij Boulevard,janbazSquare,Imam Jafar Sadegh Hospital</address>
        <city>Meybod</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8961977138</zip>
        <telephone>+98 35 3235 1200</telephone>
        <email>sadeghhosp@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ghiyasi Shahmabadi Mina</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sepehr Alley 13, Rashid al-Din Ave</address>
        <city>Maybod</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8961974360</zip>
        <telephone>+98 35 3235 8692</telephone>
        <email>www.m.ghiasi@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age is over 18 years old
Pregnancy is legitimate
Married and have permanent marriage
Have Iranian ethnicity
Both groups have virtual intervention and mobile presence
Both groups have Internet and mobile Internet literacy and / or IOS
Interested in attending counseling sessions
Of the obligation to carry out the relevant assignments (attending all meetings or at least 6 sessions and carrying out more than 75% of the assignments to the consultant's appointment)
Pregnancy is wanted
Have a history of abortion</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>According to the research unit, there is a history of alcohol and tobacco use and drugs such as antidepressants
Simultaneously participate in the same study
There is a problem that causes an increase in sadness, anxiety and depression, such as close relatives, etc. in the last 2 months
The systemic, genetic, or psychiatric diseases are afflicted by a research unit itself
Be pregnant</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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Virtual Consultation.Virtual consultancy is provided in multimedia and attractive format and one day a week by virtual method through installing one of the authorized Persian messaging software and having the ability to secure private space suitable for mobile phone research units, and from them You will be asked to submit your questions online and get help from the researcher. It is worth mentioning that for the purpose of providing Internet chat, the package is provided weekly and free of charge to the virtual intervention group by the researcher until the end of the study period. For this purpose, the mobile number of the research units will be designed by the researcher after receiving informed consent and the group will be designed to respond to the researcher. Regarding how to coordinate with research units, such as attending a group chat at the scheduled time, homework reminders, or the desire to have a private chat after the end of the chat group, the necessary information is provided by the researcher.</i_keyword>
      <i_keyword>Intervention group: In-person counseling.Individuals under the group counseling protocol are included in eight 90-minute counseling sessions on meta-cognitive therapy advised by supervisors, psychologist, counselor, and observer.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The percentage of people with a Beck Anxiety Scale is above 15. Timepoint: Determine and compare the mean of anxiety score before the intervention, the end of the eighth week of intervention and the 12th week of intervention. Method of measurement: Beck Anxiety Inventory.</prim_outcome>
      <prim_outcome>Percentage of people whose score of questionnaire is above 17. Timepoint: Determination and comparison of the mean scores of anesthesia before the onset of intervention, the end of the eighth week of intervention and the 12th week of intervention. Method of measurement: metaworry questionnaires.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-10</approval_date>
        <contact_name>Ethics Committee of Yazd University of Medical Sciences</contact_name>
        <contact_address>Bahonar Square- Central building of Shahid Sadoughi University of Medical Sciences and Health Services Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
