<?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>IRCT20191106045356N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-21</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effectiveness of pharmacotherapy with sertraline versus Glaser reality therapy in social anxiety disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of pharmacotherapy with sertraline versus Glaser reality therapy in social anxiety disorder in medical sciences students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50316</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize the samples in each group, the subjects are divided into three groups A, B and C using the RAN() function of Excel software, and according to the type of intervention, drug use and participation in mental training classes. It is a treatment, there is no possibility of blindness, there is no intervener and the subjects, and only the statistical analyst does not know what kind of intervention was done by each group.</study_design>
      <phase>3</phase>
      <hc_freetext>Social anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Venlafaxine treatment will receive sertraline (50 mg daily) for 28 days, after which they will answer the questionnaire questions. In order to evaluate the effect of time on maintaining the effect of the intervention, after two months, the subjects will be asked to answer the research questionnaires again. Finally, the data will be statistically analyzed using spss24 software and multivariate analysis of covariance. Intervention 2: Intervention group: Participate in Glasser reality therapy classes in 8 sessions of 1.5 hours and two sessions per week. At the end of the sessions, all groups will answer the questions of the relevant questionnaire. In order to evaluate the effect of time on maintaining the effect of the intervention, again after two months from the last session, the subjects will be asked to answer the research questionnaires again. Finally, the data will be statistically analyzed using SPSS24 software and multivariate analysis of covariance. Summary of Glasser reality therapy therapy sessions are: introduction and introduction, introduction and purpose of the group and the number of sessions, introduction of members to each other and expressing their expectations of each other, expression of group rules. Completing the pre-test, presenting the homework, reviewing the homework of the previous session, teaching 5 basic needs from Glasser's point of view and the concept of responsibility and selection, categorizing 5 demands related to the homework of the previous week in these 5 categories by members, submitting homework, reviewing homework of the previous session, Behavior machine training and the effect of thoughts and actions on emotions and bodily changes in the form of behavior machine using members' views, examining social anxiety and examining emotions and bodily changes when social anxiety occurs, presenting homework, reviewing the previous session, teaching the desirable world And the role of desires in creating the desired world and its difference with behavior and basic needs, examining the costs of social anxiety and its importance in life and consulting members about ways to improve it using reality therapy, homework presentation, homework review of the previous session , Give a text to members to present in the meeting and receive feedback, repeat the exercise and review, present the assignment, review the assignment of the previous session, give a long text that requires group cooperation to members to present in the meeting as a group and receive feedback Repeat the exercise and review, present the homework, review the homework of the last session. Investigating the role of excuses in achieving goals. Teaching Seven Destructive Behaviors and Seven Effective Behaviors to Satisfy Needs. Introduction to preparing members for the final session, presenting assignments, reviewing previous session assignments, summarizing, receiving feedback from group members on all sessions, and results in their lives. Final, post-test tagging. Intervention 3: Intervention group: Venlafaxine treatment and Glasser reality therapy will use both types of interventions simultaneously and, like the other two interventions, a questionnaire will be used to evaluate them.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohsen Zabihi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alem sq.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916978477</zip>
        <telephone>+98 35 3820 3419</telephone>
        <email>mzabihi100@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohsen Zabihi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alem sq.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916978477</zip>
        <telephone>+98 35 3820 3419</telephone>
        <email>mzabihi100@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Earn the required score in the social anxiety test and diagnose social anxiety</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absence for more than two sessions
Addiction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Behavior</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Venlafaxine treatment will receive sertraline (50 mg daily) for 28 days, after which they will answer the questionnaire questions. In order to evaluate the effect of time on maintaining the effect of the intervention, after two months, the subjects will be asked to answer the research questionnaires again. Finally, the data will be statistically analyzed using spss24 software and multivariate analysis of covariance.</i_keyword>
      <i_keyword>Intervention group: Participate in Glasser reality therapy classes in 8 sessions of 1.5 hours and two sessions per week. At the end of the sessions, all groups will answer the questions of the relevant questionnaire. In order to evaluate the effect of time on maintaining the effect of the intervention, again after two months from the last session, the subjects will be asked to answer the research questionnaires again. Finally, the data will be statistically analyzed using SPSS24 software and multivariate analysis of covariance. Summary of Glasser reality therapy therapy sessions are: introduction and introduction, introduction and purpose of the group and the number of sessions, introduction of members to each other and expressing their expectations of each other, expression of group rules. Completing the pre-test, presenting the homework, reviewing the homework of the previous session, teaching 5 basic needs from Glasser's point of view and the concept of responsibility and selection, categorizing 5 demands related to the homework of the previous week in these 5 categories by members, submitting homework, reviewing homework of the previous session, Behavior machine training and the effect of thoughts and actions on emotions and bodily changes in the form of behavior machine using members' views, examining social anxiety and examining emotions and bodily changes when social anxiety occurs, presenting homework, reviewing the previous session, teaching the desirable world And the role of desires in creating the desired world and its difference with behavior and basic needs, examining the costs of social anxiety and its importance in life and consulting members about ways to improve it using reality therapy, homework presentation, homework review of the previous session , Give a text to members to present in the meeting and receive feedback, repeat the exercise and review, present the assignment, review the assignment of the previous session, give a long text that requires group cooperation to members to present in the meeting as a group and receive feedback Repeat the exercise and review, present the homework, review the homework of the last session. Investigating the role of excuses in achieving goals. Teaching Seven Destructive Behaviors and Seven Effective Behaviors to Satisfy Needs. Introduction to preparing members for the final session, presenting assignments, reviewing previous session assignments, summarizing, receiving feedback from group members on all sessions, and results in their lives. Final, post-test tagging</i_keyword>
      <i_keyword>Intervention group: Venlafaxine treatment and Glasser reality therapy will use both types of interventions simultaneously and, like the other two interventions, a questionnaire will be used to evaluate them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social anxiety score. Timepoint: Before and after treatment. Method of measurement: standard 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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-10</approval_date>
        <contact_name>thics committee of ُ Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Alem sq. Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
