- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03790527
Cognitive Bias Modification Training on Internet Gaming Disorder (CBM&IGD)
A Research on the Mechanism of Cognitive Bias Modification Training in Internet Gaming Disorders.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100875
- Recruiting
- State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University
-
Contact:
- Jin-Tao Zhang
- Phone Number: +861058800728
- Email: zhangjintao@bnu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CBM 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 CBM training group; Each participant will do these task twice( e.g. Before training and after training) |
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.
|
|
Sham Comparator: Sham 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) |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioral outcome
Time Frame: 60- 80 minutes after training
|
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.
|
60- 80 minutes after training
|
|
Resting-state functional connectivity alterations in brain.
Time Frame: 30-45 minutes after training
|
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
|
30-45 minutes after training
|
|
task-based fMRI brain activation
Time Frame: 45-60 minutes after training
|
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.
|
45-60 minutes after training
|
|
Correlation analysis
Time Frame: 30- 60 minutes after training
|
The correlation between functional network organization in brain across resting state ( task-based fMRI) and cognitive bias scores will be explored.
|
30- 60 minutes after training
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jin-Tao Zhang, Phd, Beijing Normal University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IGD_CBM intervention
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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