<?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>IRCT20131110015349N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-26</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Exploring the effect of cognitive – behavioral counseling on anxiety, depression, quality of life and marital satisfaction through virtual education</public_title>
      <acronym></acronym>
      <scientific_title>Exploring the effect of cognitive – behavioral counseling on anxiety, depression, quality of life and marital satisfaction through virtual education</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35465</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: People who go to the Infertility Center are being given one-on-one appointment, Blinding description: Contributors were kept blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Anxiety. Condition 2: Depression. Condition 3: Quality of Life. Condition 4: Marital Satisfaction.</hc_freetext>
      <i_freetext>Intervention 1: In this study, after obtaining a license from Islamic Azad University, Falavarjan Branch, and presenting to the research environment and ethical considerations, the case group was enrolled in a study of 30 patients with a control group of 30 who confirmed their  infertility by obstetrician. At the beginning of the work, for each sample, the title of the study and the method of work will be described and the consent form will be completed in the form of the consent form. When specifying samples, they are taken from their personal mobile phone number or email, and educational materials are provided via telegram or e-mail, as well as in plain text. Individual questions will also be answered by telegram or by message or telephone call. Anxiety, depression and quality of life will be measured before and after intervention. It should be noted that none of these women will use drugs due to depression and anxiety at the time of the research. In addition, patients will be contacted every 2 weeks during the study and will be assured of the lack of use of the medication. Intervention 2: Control group: Control group: In this study, after obtaining permission from the Islamic Azad University of Falavarjan Branch and presenting to the research environment and observing ethical considerations, the case group was enrolled in a study of 30 patients with a control group of 30 who were afflicted with infertility by obstetrician and obstetrician. . At the beginning of the work, for each sample, the title of the study and the method of work will be described and the consent form will be completed in the form of the consent form. When identifying the samples, depression anxiety, marital satisfaction and quality of life questionnaires are completed. Then, after completing one additional month, the questionnaires are completed again and the score for anxiety, depression and quality of life will be measured before and after each other. It should be noted that none of these women will use drugs due to depression and anxiety at the time of the research. Made In addition, patients will be contacted every 2 weeks during the study and will be assured of the lack of use of the medication. And in the event of a problem, due to ethical considerations, they were advised and excluded from 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>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>maryam allahdadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, University Blvd., Basij Boulevard, Falavarjan</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15584515</zip>
        <telephone>+98 31 3742 6614</telephone>
        <email>maryamallahdadian@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>maryamallahdadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, University Blvd., Basij Boulevard, Falavarjan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15584515</zip>
        <telephone>+98 31 3742 6614</telephone>
        <email>Maryamallahdadian@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of 20-45 years old
Being Muslim 
Nationality Iranian
Having at least elementary education -
Not having a degree in psychology and counseling 
No drug addiction 
Not having severe and well-known physical and mental illness</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to participate in research 
Patients who used anti-depressant and anti-inflammatory drugs during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
      <hc_code>F31.10</hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
      <hc_keyword>Bipolar disorder, current episode manic without psychotic features, unspecified</hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, after obtaining a license from Islamic Azad University, Falavarjan Branch, and presenting to the research environment and ethical considerations, the case group was enrolled in a study of 30 patients with a control group of 30 who confirmed their  infertility by obstetrician. At the beginning of the work, for each sample, the title of the study and the method of work will be described and the consent form will be completed in the form of the consent form. When specifying samples, they are taken from their personal mobile phone number or email, and educational materials are provided via telegram or e-mail, as well as in plain text. Individual questions will also be answered by telegram or by message or telephone call. Anxiety, depression and quality of life will be measured before and after intervention. It should be noted that none of these women will use drugs due to depression and anxiety at the time of the research. In addition, patients will be contacted every 2 weeks during the study and will be assured of the lack of use of the medication</i_keyword>
      <i_keyword>Control group: Control group: In this study, after obtaining permission from the Islamic Azad University of Falavarjan Branch and presenting to the research environment and observing ethical considerations, the case group was enrolled in a study of 30 patients with a control group of 30 who were afflicted with infertility by obstetrician and obstetrician. . At the beginning of the work, for each sample, the title of the study and the method of work will be described and the consent form will be completed in the form of the consent form. When identifying the samples, depression anxiety, marital satisfaction and quality of life questionnaires are completed. Then, after completing one additional month, the questionnaires are completed again and the score for anxiety, depression and quality of life will be measured before and after each other. It should be noted that none of these women will use drugs due to depression and anxiety at the time of the research. Made In addition, patients will be contacted every 2 weeks during the study and will be assured of the lack of use of the medication. And in the event of a problem, due to ethical considerations, they were advised and excluded from intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: Before and one month after the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before and one month after the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Marital Satisfaction. Timepoint: Before and one month after the intervention. Method of measurement: questionnaire.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-03</approval_date>
        <contact_name>Islamic Azad University of Najaf Abad</contact_name>
        <contact_address>Islamic Azad University of Najaf Abadad, University Blvd. Najaf Abad Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
