<?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>IRCT20220503054731N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-10</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of schema therapy on early maladaptive schemas, dysfunctional attitudes and self-concep</public_title>
      <acronym></acronym>
      <scientific_title>Group schema therapy training on the severity of early maladaptive schemas, dysfunctional attitudes and self-concept of patients with social anxiety disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63402</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible samples after selection will be assigned to the control and intervention groups in a simple random method.  For concealment, we use allocation concealment, which is the method used to execute random sequences on study participants so that the assigned group is not known before the individual is assigned.  Using opaque envelopes sealed with random sequences in (Sealed, Sequentially Envelopes, Numbered), this method records each of the random sequences created on a card and the cards are enclosed in envelopes.  Are placed in order.  In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface.  Finally, the letter envelopes are glued and placed in a box, respectively.  At the beginning of the registration of participants, based on the order of entry of eligible participants to the study, one of the envelopes is opened in order and the assigned group of the participant is revealed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with social anxiety disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Students of Lahijan Branch of Azad University. The statistical population of this study will consist of all students studying at the Islamic Azad University, Lahijan Branch in the academic year 1401-1400. The 40 students will be randomly selected and assigned to two groups (20 in the experimental group and 20 in the control group). In relation to therapeutic intervention and data collection, the following protocol and tools will be used: - Schema therapy protocol: In this research, the schema therapy protocol will be used for intervention. This protocol was developed by Yang et al. (1950). The protocol is presented in 8 sessions (60 minutes). All participants complete the Young Yang Early maladaptive Schema Questionnaire, Connor et al.'s Social Anxiety Questionnaire, Beck Self-Concept, Wiseman and Beck Dysfunctional Attitudes, and the experimental group is trained in Schema Therapy intervention. The consent form of participation in the research is provided to them and the necessary explanations are provided about the purpose and structure of the treatment, emphasis on doing homework and how to hold sessions, and the questions and ambiguities of the people present in the research are answered. They are mentally prepared to attend treatment sessions and the post-test will be performed after the end of the intervention period. Intervention 2: Control group: Students of Lahijan Branch of Azad University do not receive schema therapy training.  The 40 students will be randomly selected and assigned to two groups (20 in the experimental group and 20 in the control group).  All participants complete the Young Yang Early maladaptive Schema Questionnaire, Connor et al.'s Social Anxiety Questionnaire, Beck Self-Concept, Wiseman's Beck Incompetent Attitudes, and will be administered at the end of the post-test.</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:
The total results obtained from the results of the questionnaire and testing and performance improvement will be published.

When:
Access period starts 6 months after the results are published

To whom:
Data and other documents are available to all researchers in the field of research.

Conditions:
If other people request data and documentation, send a message to my personal email.

Where to obtain:
Applicants should refer to Lahijan, Kashif Sharghi St., at the end of Shaghayegh St., Lahijan Branch of Azad University, to receive the required documents or data. Azar jamshidi chenari by phone number 09393158962 and email Azarjamshidi2018@gmail.com responsive.

How to obtain:
Applicants should call 09393158962 or send an email to Azarjamshidi2018@gmail.com receive the required documents or data. Documents will be provided to them within 72 hours to a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azar Jamshidi Chenari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alley 20, Baqer Al-Uloom2 Street, Volks Quarter, The End Of Shahid Eftekhari Blv, Rasht.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41489-34451</zip>
        <telephone>+98 902 334 3872</telephone>
        <email>Azarjamshidi2018@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azar Jamshidi Chenari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alley 20, Baqer Al-Uloom2 Street, Volks Quarter, The End Of Shahid Eftekhari Blv, Rasht.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41489-34451</zip>
        <telephone>+98 902 334 3872</telephone>
        <email>Azarjamshidi2018@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All students of Islamic Azad University, Lahijan Branch
Students between the ages of 19 and 40
Students with anxiety disorders</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with a clinical history of mental disorders
Patients taking psychiatric medications</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Social phobias</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Students of Lahijan Branch of Azad University. The statistical population of this study will consist of all students studying at the Islamic Azad University, Lahijan Branch in the academic year 1401-1400. The 40 students will be randomly selected and assigned to two groups (20 in the experimental group and 20 in the control group). In relation to therapeutic intervention and data collection, the following protocol and tools will be used: - Schema therapy protocol: In this research, the schema therapy protocol will be used for intervention. This protocol was developed by Yang et al. (1950). The protocol is presented in 8 sessions (60 minutes). All participants complete the Young Yang Early maladaptive Schema Questionnaire, Connor et al.'s Social Anxiety Questionnaire, Beck Self-Concept, Wiseman and Beck Dysfunctional Attitudes, and the experimental group is trained in Schema Therapy intervention. The consent form of participation in the research is provided to them and the necessary explanations are provided about the purpose and structure of the treatment, emphasis on doing homework and how to hold sessions, and the questions and ambiguities of the people present in the research are answered. They are mentally prepared to attend treatment sessions and the post-test will be performed after the end of the intervention period.</i_keyword>
      <i_keyword>Control group: Students of Lahijan Branch of Azad University do not receive schema therapy training.  The 40 students will be randomly selected and assigned to two groups (20 in the experimental group and 20 in the control group).  All participants complete the Young Yang Early maladaptive Schema Questionnaire, Connor et al.'s Social Anxiety Questionnaire, Beck Self-Concept, Wiseman's Beck Incompetent Attitudes, and will be administered at the end of the post-test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Early maladaptive schemas in Yang Early maladaptive schemas questionnaire ( YSQ-SF ). Timepoint: Measurement of initial maladaptive schemas at the beginning of the study and after eight sessions of intervention. Method of measurement: Yang Early Incompatible Schemas Questionnaire ( YSQ-SF ).</prim_outcome>
      <prim_outcome>Dysfunctional Attitudes in the Wiseman and Beck Dysfunctional Attitudes Questionnaire ( DAS-26 ). Timepoint: Measuring dysfunctional attitudes at the beginning of the study and after eight sessions of intervention. Method of measurement: Wiseman and Beck Inefficient Attitudes Questionnaire ( DAS-26 ).</prim_outcome>
      <prim_outcome>Self-concept in Beck Self-Concept Questionnaire (BSCT). Timepoint: Measurement of self-concept at the beginning of the study and after eight sessions of intervention. Method of measurement: Beck Self-Concept Questionnaire (BSCT).</prim_outcome>
      <prim_outcome>Social Anxiety Disorder in the Social Anxiety Questionnaire by Connor et al. Timepoint: Measurement of social anxiety at the beginning of the study and after eight sessions of intervention. Method of measurement: Questionnaire of social anxiety of Connor et al.</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>2022-04-09</approval_date>
        <contact_name>Ethics Committee of Lahijan Branch of Azad University</contact_name>
        <contact_address>Alley 20, Baqer Al-Uloom2 Street, Volks Quarter, The end of Shahid Eftekhari Blv, Rasht. Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
