<?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>IRCT20220413054521N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-27</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of group training of emotional regulation techniques on problem solving skills and social anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The impact of group training in emotional regulation techniques on problem solving skill and social anxiety in secondary school female students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75505</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: The participants will be randomly assigned to two groups by simple randomization. The unit of randomization is individual. The tool of randomization is a table of random numbers. First, one of the four districts of education in Shiraz city will be selected by lottery. From the selected district, two high schools will be chosen by lottery. From each school, 25 students will be selected based on the inclusion criteria and randomly assigned to one of the two groups using a table of random numbers. Blinding will be done about the statistical analyzer, Blinding description: In this study, blinding will be done about the statistical analyst.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Social Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Intervention group: The intervention for this group is the training of emotional regulation techniques. Before starting the intervention, a pre-test will be taken from this group. These trainings are offered in groups. Training is one session per week and each session lasts for one hour. The mentioned intervention will continue for eight weeks. At the end of each training session, the relevant assignment is determined and the next session of homework is reviewed. Emotional regulation techniques are taught based on related sources and the book of Leahy's Applied Psychotherapy Emotional Regulation Techniques and under the supervision of professors of the psychiatric nursing department. The content of the eight mentioned sessions is summarized as follows: First session: stating the main and secondary goals, stating the logic and stages of the intervention and stating the framework and rules, pre-test, defining emotion regulation, the necessity of emotion regulation, getting to know the types of positive and negative emotions. The second session: teaching the technique of labeling emotions and differentiating them from other possible emotions. The third session: Emotion normalization training. The fourth session: Teaching the technique of increasing the power of emotion acceptance. The fifth session: teaching the technique of creating atmosphere for excitement. 6th session: Teaching the technique of strengthening emotional awareness. Seventh session: Teaching the technique of light and weighting benefits and disadvantages. The eighth session: review of the presented techniques and final summary, implementation of the post-exam. Intervention 2: Control group: No intervention will be done for this group, but in order to comply with ethics, after the end of the interventions, the training of emotional regulation techniques provided to the intervention group will be given to the control group in the form of a pamphlet.</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>Narjes Nick</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery of Hazrat Fatemeh., entrance of Namazi Hospital., Namazi Square., Shiraz Province</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>nikn@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narjes Nick</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery of Hazrat Fatemeh., entrance of Namazi Hospital., Namazi Square., Shiraz Province</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>nikn@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being a female student of the second level of secondary school
Willingness of students to participate in research
Written informed consent of students and parents to participate in the research project
Not receiving psychological treatments at the same time or at least six months before entering the research
Failure to participate in similar research or training at the same time
Living with parents at the same time</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Suffering from any type of physical disease or debilitating psychological disease (confirmed by a specialist doctor) that affects the student's ability to participate in training sessions
The student has experienced a specific crisis such as the loss of family members (parents, siblings) during the past six months
In the current academic year, the transfer student is from another city except Shiraz
The student is absent from intervention sessions for more than one session</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:  Intervention group: The intervention for this group is the training of emotional regulation techniques. Before starting the intervention, a pre-test will be taken from this group. These trainings are offered in groups. Training is one session per week and each session lasts for one hour. The mentioned intervention will continue for eight weeks. At the end of each training session, the relevant assignment is determined and the next session of homework is reviewed. Emotional regulation techniques are taught based on related sources and the book of Leahy's Applied Psychotherapy Emotional Regulation Techniques and under the supervision of professors of the psychiatric nursing department. The content of the eight mentioned sessions is summarized as follows: First session: stating the main and secondary goals, stating the logic and stages of the intervention and stating the framework and rules, pre-test, defining emotion regulation, the necessity of emotion regulation, getting to know the types of positive and negative emotions. The second session: teaching the technique of labeling emotions and differentiating them from other possible emotions. The third session: Emotion normalization training. The fourth session: Teaching the technique of increasing the power of emotion acceptance. The fifth session: teaching the technique of creating atmosphere for excitement. 6th session: Teaching the technique of strengthening emotional awareness. Seventh session: Teaching the technique of light and weighting benefits and disadvantages. The eighth session: review of the presented techniques and final summary, implementation of the post-exam.</i_keyword>
      <i_keyword>Control group: No intervention will be done for this group, but in order to comply with ethics, after the end of the interventions, the training of emotional regulation techniques provided to the intervention group will be given to the control group in the form of a pamphlet.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social anxiety. Timepoint: Before the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: LaGreca Social anxiety questionnaire for Adolescents.</prim_outcome>
      <prim_outcome>Social problem-solving skills. Timepoint: Before the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: D'Zurilla et al.'s Social Problem solving Inventory _ Revised.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-27</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Shiraz, Zand Street, Central Building of Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
