<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03790527</url>
  </required_header>
  <id_info>
    <org_study_id>IGD_CBM intervention</org_study_id>
    <nct_id>NCT03790527</nct_id>
  </id_info>
  <brief_title>Cognitive Bias Modification Training on Internet Gaming Disorder</brief_title>
  <acronym>CBM&amp;IGD</acronym>
  <official_title>A Research on the Mechanism of Cognitive Bias Modification Training in Internet Gaming Disorders.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Normal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Normal University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate whether and how the CBM training will alleviate the symptoms of addiction in&#xD;
      Internet gaming disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to use the modification training of cognitive bias to ameliorate&#xD;
      the severity and symptoms of Internet gaming disorders(IGD); the neural mechanisms of&#xD;
      cognitive bias modification and its effect during cued-induced craving task in subjects with&#xD;
      IGD will be investigated as well. This project will be conducted in Beijing, China.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 13, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The investigators assigned subjects to two training groups and collected pre - and post-test data</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>double blind: both participants and experimenters won't know which group is training group or sham control group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Behavioral outcome</measure>
    <time_frame>60- 80 minutes after training</time_frame>
    <description>Cognitive bias outside fMRI measured by AAT task takes the response times[[Push_game_pic-Pull_game_pic]-[Push_object_pic - Pull_object_pic])] as the index. The response times (cognitive bias scores) will be calculated under Repeated Measurement Anova by using SPSS software.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resting-state functional connectivity alterations in brain.</measure>
    <time_frame>30-45 minutes after training</time_frame>
    <description>Using seed-based and network level functional connectivity analysis, as well as graph theory analysis , functional connectivity in brain under eight minutes resting state will be detected and compared between CBM training group and sham group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>task-based fMRI brain activation</measure>
    <time_frame>45-60 minutes after training</time_frame>
    <description>The active of the brain regions in mPFC and VS during AAT task changes after CBM training compared with the sham. There should be an decrease in ventral striatum and amygdala during the cue-induced task. These task-based fMRI data will be contrasted using SPM.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation analysis</measure>
    <time_frame>30- 60 minutes after training</time_frame>
    <description>The correlation between functional network organization in brain across resting state ( task-based fMRI) and cognitive bias scores will be explored.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Internet Gaming Disorder</condition>
  <arm_group>
    <arm_group_label>CBM training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>participants have to complete the picture assessment task ; Approach-avoidance Task(AAT) and cue-induced task in the fMRI；data on game-craving level, game hours, the ability of self-control and emotion regulation are also collected.&#xD;
Half of the participants will be random-assigned into the CBM training group; Each participant will do these task twice( e.g. Before training and after training)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham training</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>participants have to complete the picture assessment task ; Approach-avoidance Task(AAT) and cue-induced task in the fMRI；data on game-craving level, game hours, the ability of self-control and emotion regulation are also collected.&#xD;
Half of the participants will be random-assigned into the sham training group; Each participant will do these task twice( e.g. Before training and after training)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CBM training</intervention_name>
    <description>participants will be random-assigned into one of training groups. Participants in the modification group will receive modified training of 400 trials for six sessions during six days, the same as the sham group.The difference between these two groups is the proportion of push/pull trials. The sequence of the interventions will be counterbalanced across participants, and the callback will be conduct after one week.</description>
    <arm_group_label>CBM training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham training</intervention_name>
    <description>participants will be random-assigned into one of training groups. Participants in the modification group will receive modified training of 400 trials for six sessions during six days, the same as the sham group.The difference between these two groups is the proportion of push/pull trials. The sequence of the interventions will be counterbalanced across participants, and the callback will be conduct after one week.</description>
    <arm_group_label>Sham training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1, DSM-5 recommended diagnosis of Internet gaming disorder :&#xD;
&#xD;
          1. the scores of the 9 items of DSM-5 recommended diagnosis for Internet gaming disorder&#xD;
             ≥ 5.&#xD;
&#xD;
          2. engagement in popular Internet games (e.g. Arena of Valor, League of Legends and&#xD;
             Player Unknown's Battle Grounds) for over 20 hours per week for a minimum of 12&#xD;
             months.&#xD;
&#xD;
        2, the scores of the Y-IAT(Young-Internet addiction Test) ≥ 50&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        current or history of use of illegal substances and gambling;&#xD;
&#xD;
        current or history of psychiatric or neurological illness;&#xD;
&#xD;
        current use of psychotropic medications.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin-Tao Zhang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Normal University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rui Wang, Master</last_name>
    <phone>+8618810315922</phone>
    <email>851006286@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jin-Tao Zhang, PhD</last_name>
    <phone>+8610 58800728</phone>
    <email>zhangjintao@bnu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100875</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin-Tao Zhang</last_name>
      <phone>+861058800728</phone>
      <email>zhangjintao@bnu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Wiers CE, Stelzel C, Gladwin TE, Park SQ, Pawelczack S, Gawron CK, Stuke H, Heinz A, Wiers RW, Rinck M, Lindenmeyer J, Walter H, Bermpohl F. Effects of cognitive bias modification training on neural alcohol cue reactivity in alcohol dependence. Am J Psychiatry. 2015 Apr;172(4):335-43. doi: 10.1176/appi.ajp.2014.13111495. Epub 2014 Dec 19.</citation>
    <PMID>25526597</PMID>
  </reference>
  <reference>
    <citation>Wiers CE, Ludwig VU, Gladwin TE, Park SQ, Heinz A, Wiers RW, Rinck M, Lindenmeyer J, Walter H, Bermpohl F. Effects of cognitive bias modification training on neural signatures of alcohol approach tendencies in male alcohol-dependent patients. Addict Biol. 2015 Sep;20(5):990-9. doi: 10.1111/adb.12221. Epub 2015 Jan 13.</citation>
    <PMID>25639749</PMID>
  </reference>
  <reference>
    <citation>Rinck M, Becker ES. Approach and avoidance in fear of spiders. J Behav Ther Exp Psychiatry. 2007 Jun;38(2):105-20. doi: 10.1016/j.jbtep.2006.10.001. Epub 2006 Nov 28.</citation>
    <PMID>17126289</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>August 19, 2019</last_update_submitted>
  <last_update_submitted_qc>August 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Normal University</investigator_affiliation>
    <investigator_full_name>Jin-tao Zhang</investigator_full_name>
    <investigator_title>Associated Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Internet Addiction Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03790527
org study id: IGD_CBM intervention
nct id: NCT03790527
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To investigate whether and how the CBM training will alleviate the symptoms of addiction in
      Internet gaming disorders.
The purpose of this study is to use the modification training of cognitive bias to ameliorate
      the severity and symptoms of Internet gaming disorders(IGD); the neural mechanisms of
      cognitive bias modification and its effect during cued-induced craving task in subjects with
      IGD will be investigated as well. This project will be conducted in Beijing, China.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The investigators assigned subjects to two training groups and collected pre - and post-test data
primary purpose: Basic Science
masking: Double (Participant, Investigator)
masking description: double blind: both participants and experimenters won't know which group is training group or sham control group.
measure: Behavioral outcome
time frame: 60- 80 minutes after training
description: Cognitive bias outside fMRI measured by AAT task takes the response times[[Push_game_pic-Pull_game_pic]-[Push_object_pic - Pull_object_pic])] as the index. The response times (cognitive bias scores) will be calculated under Repeated Measurement Anova by using SPSS software.
measure: Resting-state functional connectivity alterations in brain.
time frame: 30-45 minutes after training
description: Using seed-based and network level functional connectivity analysis, as well as graph theory analysis , functional connectivity in brain under eight minutes resting state will be detected and compared between CBM training group and sham group
measure: task-based fMRI brain activation
time frame: 45-60 minutes after training
description: The active of the brain regions in mPFC and VS during AAT task changes after CBM training compared with the sham. There should be an decrease in ventral striatum and amygdala during the cue-induced task. These task-based fMRI data will be contrasted using SPM.
measure: Correlation analysis
time frame: 30- 60 minutes after training
description: The correlation between functional network organization in brain across resting state ( task-based fMRI) and cognitive bias scores will be explored.
arm group label: CBM training
arm group type: Experimental
description: participants have to complete the picture assessment task ; Approach-avoidance Task(AAT) and cue-induced task in the fMRI；data on game-craving level, game hours, the ability of self-control and emotion regulation are also collected.
Half of the participants will be random-assigned into the CBM training group; Each participant will do these task twice( e.g. Before training and after training)
arm group label: Sham training
arm group type: Sham Comparator
description: participants have to complete the picture assessment task ; Approach-avoidance Task(AAT) and cue-induced task in the fMRI；data on game-craving level, game hours, the ability of self-control and emotion regulation are also collected.
Half of the participants will be random-assigned into the sham training group; Each participant will do these task twice( e.g. Before training and after training)
intervention type: Procedure
intervention name: CBM training
description: participants will be random-assigned into one of training groups. Participants in the modification group will receive modified training of 400 trials for six sessions during six days, the same as the sham group.The difference between these two groups is the proportion of push/pull trials. The sequence of the interventions will be counterbalanced across participants, and the callback will be conduct after one week.
arm group label: CBM training
intervention type: Procedure
intervention name: Sham training
description: participants will be random-assigned into one of training groups. Participants in the modification group will receive modified training of 400 trials for six sessions during six days, the same as the sham group.The difference between these two groups is the proportion of push/pull trials. The sequence of the interventions will be counterbalanced across participants, and the callback will be conduct after one week.
arm group label: Sham training
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: No
last name: Jin-Tao Zhang, PhD
role: Principal Investigator
affiliation: Beijing Normal University
last name: Rui Wang, Master
phone: +8618810315922
email: 851006286@qq.com
last name: Jin-Tao Zhang, PhD
phone: +8610 58800728
email: zhangjintao@bnu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
citation: Wiers CE, Stelzel C, Gladwin TE, Park SQ, Pawelczack S, Gawron CK, Stuke H, Heinz A, Wiers RW, Rinck M, Lindenmeyer J, Walter H, Bermpohl F. Effects of cognitive bias modification training on neural alcohol cue reactivity in alcohol dependence. Am J Psychiatry. 2015 Apr;172(4):335-43. doi: 10.1176/appi.ajp.2014.13111495. Epub 2014 Dec 19.
PMID: 25526597
citation: Wiers CE, Ludwig VU, Gladwin TE, Park SQ, Heinz A, Wiers RW, Rinck M, Lindenmeyer J, Walter H, Bermpohl F. Effects of cognitive bias modification training on neural signatures of alcohol approach tendencies in male alcohol-dependent patients. Addict Biol. 2015 Sep;20(5):990-9. doi: 10.1111/adb.12221. Epub 2015 Jan 13.
PMID: 25639749
citation: Rinck M, Becker ES. Approach and avoidance in fear of spiders. J Behav Ther Exp Psychiatry. 2007 Jun;38(2):105-20. doi: 10.1016/j.jbtep.2006.10.001. Epub 2006 Nov 28.
PMID: 17126289
responsible party type: Principal Investigator
investigator affiliation: Beijing Normal University
investigator full name: Jin-tao Zhang
investigator title: Associated Professor
mesh term: Internet Addiction Disorder
sharing ipd: Undecided