Back to resultsCognitive Bias Modification Training on Internet Gaming Disorder (CBM&IGD)
Primary Purpose
Internet Gaming Disorder
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CBM training
Sham training
Sponsored by
About this trial
This is an interventional basic science trial for Internet Gaming Disorder
Eligibility Criteria
Inclusion Criteria:
1, DSM-5 recommended diagnosis of Internet gaming disorder :
- the scores of the 9 items of DSM-5 recommended diagnosis for Internet gaming disorder ≥ 5.
- engagement in popular Internet games (e.g. Arena of Valor, League of Legends and Player Unknown's Battle Grounds) for over 20 hours per week for a minimum of 12 months.
2, the scores of the Y-IAT(Young-Internet addiction Test) ≥ 50
Exclusion Criteria:
current or history of use of illegal substances and gambling;
current or history of psychiatric or neurological illness;
current use of psychotropic medications.
Sites / Locations
- State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
CBM training
Sham training
Arm 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)
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)
Outcomes
Primary Outcome Measures
Behavioral outcome
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.
Resting-state functional connectivity alterations in brain.
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
task-based fMRI brain activation
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.
Correlation analysis
The correlation between functional network organization in brain across resting state ( task-based fMRI) and cognitive bias scores will be explored.
Secondary Outcome Measures
Full Information
NCT ID
NCT03790527
First Posted
December 26, 2018
Last Updated
August 19, 2019
Sponsor
Beijing Normal University
1. Study Identification
Unique Protocol Identification Number
NCT03790527
Brief Title
Cognitive Bias Modification Training on Internet Gaming Disorder
Acronym
CBM&IGD
Official Title
A Research on the Mechanism of Cognitive Bias Modification Training in Internet Gaming Disorders.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 13, 2019 (Actual)
Primary Completion Date
October 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Normal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate whether and how the CBM training will alleviate the symptoms of addiction in Internet gaming disorders.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Internet Gaming Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators assigned subjects to two training groups and collected pre - and post-test data
Masking
ParticipantInvestigator
Masking Description
double blind: both participants and experimenters won't know which group is training group or sham control group.
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBM training
Arm Type
Experimental
Arm 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 Title
Sham training
Arm Type
Sham Comparator
Arm 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(s)
CBM training
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Sham training
Intervention 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.
Primary Outcome Measure Information:
Title
Behavioral outcome
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.
Time Frame
60- 80 minutes after training
Title
Resting-state functional connectivity alterations in brain.
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
Time Frame
30-45 minutes after training
Title
task-based fMRI brain activation
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.
Time Frame
45-60 minutes after training
Title
Correlation analysis
Description
The correlation between functional network organization in brain across resting state ( task-based fMRI) and cognitive bias scores will be explored.
Time Frame
30- 60 minutes after training
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1, DSM-5 recommended diagnosis of Internet gaming disorder :
the scores of the 9 items of DSM-5 recommended diagnosis for Internet gaming disorder ≥ 5.
engagement in popular Internet games (e.g. Arena of Valor, League of Legends and Player Unknown's Battle Grounds) for over 20 hours per week for a minimum of 12 months.
2, the scores of the Y-IAT(Young-Internet addiction Test) ≥ 50
Exclusion Criteria:
current or history of use of illegal substances and gambling;
current or history of psychiatric or neurological illness;
current use of psychotropic medications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rui Wang, Master
Phone
+8618810315922
Email
851006286@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Tao Zhang, PhD
Phone
+8610 58800728
Email
zhangjintao@bnu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tao Zhang, PhD
Organizational Affiliation
Beijing Normal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100875
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Tao Zhang
Phone
+861058800728
Email
zhangjintao@bnu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25526597
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.
Results Reference
background
PubMed Identifier
25639749
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.
Results Reference
background
PubMed Identifier
17126289
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.
Results Reference
background
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Cognitive Bias Modification Training on Internet Gaming Disorder
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