<?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>IRCT20221214056816N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-25</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating cognitive-behavioral therapy and direct current brain stimulation (tDCS) in Internet addiction</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of cognitive-behavioral therapy and transcranial direct current stimulation(tDCS) in reducing symptoms and improving the executive functions of students with Internet addiction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70006</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The initial samples will be available as sampling, and then according to the screening tools, those who have been diagnosed with Internet addiction will be selected through simple randomization using computer programs from the table of random numbers to be assigned to sham and treatment groups. became. In this method, all members of the community have an equal chance to be elected.
To use the table of random numbers, the researcher first defines the framework of his statistical society; and gives them a code or machine gun number respectively so that the samples can be selected.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Internet addiction.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: cognitive-behavioral therapy specific to Internet addiction, deals with recognizing dysfunctional feelings and actions, social and behavioral defects, motivation, and creating alternative behaviors, which includes twelve weekly sessions and a six-month follow-up. Intervention 2: The second intervention group: transcranial direct current stimulation by the Actiodose device made in Canada, which is a non-invasive, painless and tolerable brain stimulation technique that is able to change the activation of the cerebral cortex and a weak direct current through surface electrodes on the scalp. It applies this weak and direct current through the connection of two electrodes, anode and cathode, at different points on the surface of the skull, leading to an increase and decrease in the stimulation of the underlying neurons. This treatment will be 12 sessions of 20 minutes. Intervention 3: Sham group: Electrodes will be placed on their skulls, but no brain stimulation will take place. This treatment will be 12 sessions of 20 minutes by tDCS actiodose device made in Canada. Intervention 4: Control group: No treatment is performed and only evaluations are performed.</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>Mehdi khani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Specialized and Subspecialized Medical Training Center - Above Arg Square -Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956184</zip>
        <telephone>+98 24 3354 4001</telephone>
        <email>m.xani1990@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zakaria Eskandari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Addiction studies department, Beheshti Hospital, Zanjan University of Medical Science, Znjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513615788</zip>
        <telephone>+98 24 3315 6444</telephone>
        <email>dreskandari@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Informed consent and voluntary participation in internet addiction treatment sessions
Being at least 18 and at most 38 years old
Being a student
Being diagnosed with internet addiction</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>38 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having other psychiatric disorders such as depression, schizophrenia, other psychotic disorders, obsessive disorders, bipolar disorder, anxiety disorders, etc.
Receiving psychiatric drugs
Receiving psychological treatments</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>Treatment - Other</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Placebo</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: cognitive-behavioral therapy specific to Internet addiction, deals with recognizing dysfunctional feelings and actions, social and behavioral defects, motivation, and creating alternative behaviors, which includes twelve weekly sessions and a six-month follow-up.</i_keyword>
      <i_keyword>The second intervention group: transcranial direct current stimulation by the Actiodose device made in Canada, which is a non-invasive, painless and tolerable brain stimulation technique that is able to change the activation of the cerebral cortex and a weak direct current through surface electrodes on the scalp. It applies this weak and direct current through the connection of two electrodes, anode and cathode, at different points on the surface of the skull, leading to an increase and decrease in the stimulation of the underlying neurons. This treatment will be 12 sessions of 20 minutes.</i_keyword>
      <i_keyword>Sham group: Electrodes will be placed on their skulls, but no brain stimulation will take place. This treatment will be 12 sessions of 20 minutes by tDCS actiodose device made in Canada.</i_keyword>
      <i_keyword>Control group: No treatment is performed and only evaluations are performed</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Young's Internet Addiction Questionnaire score. Timepoint: Pre-test, before the intervention - post-test, 1 week after the intervention - follow-up, 3 months after the intervention. Method of measurement: Young Internet Addiction Questionnaire.</prim_outcome>
      <prim_outcome>Nejati Cognitive Abilities Questionnaire score. Timepoint: Pre-test, before the intervention - post-test, 1 week after the intervention - follow-up, 3 months after the intervention. Method of measurement: Nejati Cognitive Abilities Questionnaire.</prim_outcome>
      <prim_outcome>Gertz and Roemer's Emotion Regulation Difficulty Questionnaire score. Timepoint: Pre-test, before the intervention - post-test, 1 week after the intervention - follow-up, 3 months after the intervention. Method of measurement: Roemer's Emotion Regulation Difficulty Questionnaire.</prim_outcome>
      <prim_outcome>Bart's Impulsivity Questionnaire score. Timepoint: Pre-test, before the intervention - post-test, 1 week after the intervention - follow-up, 3 months after the intervention. Method of measurement: Barrett's Impulsivity Test.</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-11</approval_date>
        <contact_name>Ethics Committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Zanjan University of Medical Sciences, SHahrak town, Mahdavi Blvd., zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
