<?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>IRCT20180208038667N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-25</date_registration>
      <primary_sponsor>Cognitive Sciences and Technologies Council</primary_sponsor>
      <public_title>Investigating the effect of cognitive behavioral therapy with and without cognitive training on patients with internet gaming disorder</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of cognitive-behavioral therapy for internet addiction with and without cognitive training on improving the cognitive functions of patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58486</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the classification of sample individuals into two treatment and control groups will be done using Restricted randomization method through random allocation rule in the following way: after selecting 40 sample , 20 balls will be assigned to the control group and 20 balls to the treatment group, these balls will be placed in a lottery box and then randomly, without replacement, balls will be removed from the box and the sequence will be recorded, Blinding description: In this study, all participants in the two treatment and control groups, the therapist who is responsible for pre-, during-, and post-treatment evaluations, and the data analyst are kept blind to the differences between the two treatment groups in terms of the type of interventions and which group each individual is assigned to.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gaming disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group will undergo combined cognitive behavioral therapy for Internet addiction (CBT-IA) and cognitive training. CBT-IA treatment introduced by Young et al. (2011) includes elements of traditional Cognitive Behavioral Therapy (CBT) and internet-related interventions to address internet addiction. This treatment is conducted over 12 weekly sessions, consisting of three phases: 1) behavioral modification 2) cognitive restructuring 3) harm reduction. In addition, cognitive training such as GO/NOGO and approach/avoidance adapted for internet gaming disorder are provided in the first and second phase, where individuals are instructed and given therapeutic tasks to practice this computer-based tasks as part of the therapeutic assignments in addition to CBT-IA therapeutic tasks during the intervals between sessions. Intervention 2: Control group: This group will undergo Cognitive-Behavioral Therapy for Internet Addiction (CBT-IA) . CBT-IA, introduced by Young et al. (2011), encompasses classic Cognitive Behavioral Therapy (CBT) elements and internet-related interventions for treating internet addiction. This treatment consists of 12 weekly sessions and includes three phases: 1) Behavioral modification 2) Cognitive restructuring 3) Harm reduction.</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 data is presented in the form of individuals' scores in pre- and post-treatment assessments in both groups in a way that individuals' identities are unidentifiable, and it is provided in an Excel file.

When:
Access period begins 6 months after the publication of results and lasts for one year.

To whom:
Information is available for professionals, researchers, and therapists in the fields of psychology, psychiatry and cognitive sciences.

Conditions:
Researchers in the field of internet gaming addiction under the following conditions:
Keeping the data confidential and not disclosing it;
Not using the data for writing scientific research articles or participating in scientific conferences

Where to obtain:
Fahime Maleki 
Email address: fa.maleki@uswr.ac.ir

How to obtain:
Requests received via email are reviewed by the research team, and if approved, the data will be sent within 1 to 2 weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fahime Maleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 19, West 19th Ave., Tohid Blvd., Ghanat kosar</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1653667638</zip>
        <telephone>+98 21 7780 1524</telephone>
        <email>fa.maleki@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahime Maleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 19, West19th Ave., Tohid Blvd., Ghanat kosar</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1653667638</zip>
        <telephone>+98 21 7780 1624</telephone>
        <email>fa.maleki@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being over 18 years old
Suffering from internet gaming disorder</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from an organic brain disorder
Suffering from psychotic disorders
Suffering from obsessive compulsive disorder
Suffering from bipolar disorder
Suffering from substance abuse disorder
Suffering from Gambling disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>6C51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gaming disorder</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: This group will undergo combined cognitive behavioral therapy for Internet addiction (CBT-IA) and cognitive training. CBT-IA treatment introduced by Young et al. (2011) includes elements of traditional Cognitive Behavioral Therapy (CBT) and internet-related interventions to address internet addiction. This treatment is conducted over 12 weekly sessions, consisting of three phases: 1) behavioral modification 2) cognitive restructuring 3) harm reduction. In addition, cognitive training such as GO/NOGO and approach/avoidance adapted for internet gaming disorder are provided in the first and second phase, where individuals are instructed and given therapeutic tasks to practice this computer-based tasks as part of the therapeutic assignments in addition to CBT-IA therapeutic tasks during the intervals between sessions.</i_keyword>
      <i_keyword>Control group: This group will undergo Cognitive-Behavioral Therapy for Internet Addiction (CBT-IA) . CBT-IA, introduced by Young et al. (2011), encompasses classic Cognitive Behavioral Therapy (CBT) elements and internet-related interventions for treating internet addiction. This treatment consists of 12 weekly sessions and includes three phases: 1) Behavioral modification 2) Cognitive restructuring 3) Harm reduction.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reducing the total score in the short form of the Internet Gaming Disorder Scale to a score lower than 36. Timepoint: Before the start of therapeutic interventions and after the end of therapeutic interventions. Method of measurement: Internet Gaming Disorder Scale Short-Form.</prim_outcome>
      <prim_outcome>Reducing the score of maladaptive cognitions in the maladaptive gaming-related cognitions scale. Timepoint: Before starting therapeutic interventions and after the end of therapeutic interventions. Method of measurement: Maladaptive Gaming-Related Cognitions Scale.</prim_outcome>
      <prim_outcome>Reduction in the score of craving for internet gaming scale. Timepoint: Before the start of therapeutic interventions and after the end of therapeutic interventions. Method of measurement: Craving for Internet Gaming Scale.</prim_outcome>
      <prim_outcome>Improved performance in the Stroop task. Timepoint: Before the start of therapeutic interventions and after the end of therapeutic interventions. Method of measurement: Stroop task.</prim_outcome>
      <prim_outcome>Improved performance in the GO\NOGO task. Timepoint: Before the start of therapeutic interventions and after the end of therapeutic interventions. Method of measurement: GO/NOGO task.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>University of social welfare and rehabilitation sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Cognitive Sciences and Technologies Council</source_name>
      <source_name>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-25</approval_date>
        <contact_name>Research ethics committee of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>No. 19, West19th Ave., Tohid Blvd., Ghanat kosar Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
