<?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>IRCT20181226042140N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-10</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The effect of intervention of internet gaming disorder among adolescents</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of an educational intervention based on transtheoretical model in treating of internet gaming disorder among adolescents in Abyek city</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>206</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47502</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Due to changes in general health conditions and due to coronavirus disease, the sampling time of the study has changed, Randomization description: This research is a randomized trial study of a single  blind.By simple randomization, out of a total of 25 schools, 8 schools are randomly selected.Out of 8 schools, 4 are randomly assigned to control groups and 4 to random experimental groups.From each school, 30 students will be randomly selected.From each school,the number of students selected will receive a special code through the SPSS software,and then,after analyzing the data,they will be randomly selected through this codes.
In each selected cluster, all students who played video games are selected.Subjects will be randomly divided into intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Internet gaming disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The educational application is designed based on the transtheoretical model and cognitive-behavioral therapy.The tutorials are designed for 8 sessions of 30 to 45 minutes.The content of the sessions includes increasing awareness and investigating the effect of internet gaming on people's physical and mental health; It is also about identifying misconceptions about online games and it also identifies and corrects misconceptions about online games.Part of this training also includes self-control, coping responses, and overcoming temptation. Intervention 2: Control group: Online educational sessions are designed in 8 sessions, 30 minutes with the topic of sleep hygiene.The content of the sessions is designed to increase knowledge and improve sleep hygiene behavior,sleep habits,sleep management,identify incorrect patterns of behavior associated with sleep,and the impact of the environment, time, physical activity and nutrition on people's sleep.</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>Sara Fzeli Rooshande</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Bahonar Blvd., Qazvin University of Medical Sciences</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419915315</zip>
        <telephone>+98 28 3336 9581</telephone>
        <email>s.fazelirooshande@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Pakpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Social Determinants of Health Research Center.,Shahid Bahonar Blvd., Qazvin University of Medical Sciences</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419915315</zip>
        <telephone>+98 28 3334 4589</telephone>
        <email>apakpour@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Satisfaction to participate in research
Busy studying
Diagnosis of internet gaming disorder in students through the internet gaming disorder scale–short-form
Internet access
Access to computer, laptop, tablet or smartphone
Gain a score of 45 or higher on the evaluation of the initial questionnaire on internet gaming disorder
Ability to answer questionnaire questions
Lack of mental illness (such as schizophrenia and bipolar disorder) or mental disability</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Age over 18 years
Non-addiction to online games</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>DSM-5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Internet gaming disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The educational application is designed based on the transtheoretical model and cognitive-behavioral therapy.The tutorials are designed for 8 sessions of 30 to 45 minutes.The content of the sessions includes increasing awareness and investigating the effect of internet gaming on people's physical and mental health; It is also about identifying misconceptions about online games and it also identifies and corrects misconceptions about online games.Part of this training also includes self-control, coping responses, and overcoming temptation.</i_keyword>
      <i_keyword>Control group: Online educational sessions are designed in 8 sessions, 30 minutes with the topic of sleep hygiene.The content of the sessions is designed to increase knowledge and improve sleep hygiene behavior,sleep habits,sleep management,identify incorrect patterns of behavior associated with sleep,and the impact of the environment, time, physical activity and nutrition on people's sleep.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Online game addiction score. Timepoint: Before the intervention and 1 and 3 months after the start of the intervention. Method of measurement: Internet Gaming Disorder Scale–Short-Form.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Insomnia Severity Index. Timepoint: To evaluate participants, they answer the questionnaire questions before the intervention, one and three months after the intervention begins. Method of measurement: Insomnia Severity Index (ISI).</sec_outcome>
      <sec_outcome>Scores of stress, anxiety, depression. Timepoint: To evaluate participants, they answer the questionnaire questions before the intervention, one and three months after the intervention begins. Method of measurement: Depression Anxiety Stress Scales (DASS).</sec_outcome>
      <sec_outcome>Recognize the individual's position in the cycle of stages of change. Timepoint: To evaluate participants, they answer the questionnaire questions before the intervention, one and three months after the intervention begins. Method of measurement: Questionnaire of Structural Stage of change of Transtheoretical Model.</sec_outcome>
      <sec_outcome>Self-efficacy score. Timepoint: To evaluate participants, they answer the questionnaire questions before the intervention, one and three months after the intervention begins. Method of measurement: Questionnaire of Structural Self-Efficacy of Transtheoretical Model.</sec_outcome>
      <sec_outcome>Decision Balance Score. Timepoint: To evaluate participants, they answer the questionnaire questions before the intervention, one and three months after the intervention begins. Method of measurement: Questionnaire of Structural Decision Balance  of Transtheoretical  Model.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-26</approval_date>
        <contact_name>Ethics committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin - Shahid Bahonar Boulevard - Qazvin University of Medical Sciences Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
