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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03790527
Other study ID # IGD_CBM intervention
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 13, 2019
Est. completion date December 30, 2019

Study information

Verified date August 2019
Source Beijing Normal University
Contact Rui Wang, Master
Phone +8618810315922
Email 851006286@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigate whether and how the CBM training will alleviate the symptoms of addiction in Internet gaming disorders.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date December 30, 2019
Est. primary completion date October 30, 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

1, DSM-5 recommended diagnosis of Internet gaming disorder :

1. the scores of the 9 items of DSM-5 recommended diagnosis for Internet gaming disorder = 5.

2. 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
CBM 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 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.

Locations

Country Name City State
China State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Normal University

Country where clinical trial is conducted

China, 

References & Publications (3)

Rinck M, Becker ES. Approach and avoidance in fear of spiders. J Behav Ther Exp Psychiatry. 2007 Jun;38(2):105-20. Epub 2006 Nov 28. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 60- 80 minutes after training
Primary 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 30-45 minutes after training
Primary 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. 45-60 minutes after training
Primary Correlation analysis 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
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