<?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>IRCT20250611066182N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-09-05</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Cognitive behavioral therapy in reducing internet addiction, sleep quality, and mental health</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of cognitive behavioral therapy in reducing internet addiction, sleep quality, and mental health among students of Islamic Azad University of Ahvaz Branch.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-09-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/85821</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: This study used a block randomization method with a block size of 4. The sequence of group allocation (experimental/control) was generated using Excel software and protected in sealed envelopes. After screening and obtaining consent, participants were assigned to groups based on the order of arrival and opening of the envelopes, Blinding description: In this study, due to the non-blinded nature of the intervention (cognitive-behavioral therapy), only the Outcome Assessor and Data Analyst will be blinded. After random assignment of participants to the experimental and control groups, the assessor, who is responsible for collecting post-test and follow-up data, will not be aware of the purpose of the study and the type of group assignment of the participants. The data will be provided to him/her in coded form (without group identifiers). Also, the data analyst will perform statistical analysis without knowing the grouping of the samples to avoid any bias.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Internet addiction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 15 eligible students will receive a structured cognitive-behavioral therapy (CBT) protocol. The intervention will consist of 8 90-minute sessions (one session per week) with educational content and practical exercises to manage internet addiction, improve sleep quality, and improve mental health. Intervention 2: Control group: Fifteen eligible students who do not receive any active intervention and will only be assessed at pre-test, post-test, and follow-up will be included. In order to comply with ethical considerations, if the intervention is effective, similar training will be provided to this group after the study is completed.</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 No further information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narges Heydarianfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Ahvaz Branch, Farhang Shahr, Golestan Highway</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3733361349</zip>
        <telephone>+98 61 3334 8421</telephone>
        <email>info@iauahvaz.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narges Heydarianfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Ahvaz Branch, Farhang Shahr, Golestan Highway</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3733361349</zip>
        <telephone>+98 61 3334 8421</telephone>
        <email>info@iauahvaz.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be Iranian and a resident of Ahvaz city
Be a student
Have a smartphone
Have at least one year of creating an account on social networks such as Instagram, etc.
Be between 18 and 25 years of age.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Addiction to narcotics, psychotropic substances, alcohol, or medication abuse
Are under psychiatric treatment due to mental health problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F51.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sleep disorder not due to a substance or known physiological condition, unspecified</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: 15 eligible students will receive a structured cognitive-behavioral therapy (CBT) protocol. The intervention will consist of 8 90-minute sessions (one session per week) with educational content and practical exercises to manage internet addiction, improve sleep quality, and improve mental health.</i_keyword>
      <i_keyword>Control group: Fifteen eligible students who do not receive any active intervention and will only be assessed at pre-test, post-test, and follow-up will be included. In order to comply with ethical considerations, if the intervention is effective, similar training will be provided to this group after the study is completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Internet addiction. Timepoint: Pretest (before the intervention), posttest (immediately after the intervention), and follow-up (at least 2 months after the intervention). Method of measurement: Young's Internet Addiction Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sleep quality. Timepoint: Pre-test (before the intervention), post-test (immediately after the completion of the 8-week intervention), and follow-up (2 months after the completion of the intervention). Method of measurement: Pittsburgh Standardized Sleep Quality Questionnaire.</sec_outcome>
      <sec_outcome>Mental health. Timepoint: Pre-test (before the intervention), post-test (immediately after the completion of the 8-week intervention), and follow-up (2 months after the completion of the intervention). Method of measurement: Standardized General Health Questionnaire.</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>2025-06-07</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of Ahvaz</contact_name>
        <contact_address>Islamic Azad University, Ahvaz Branch, Farhang Shahr, Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
