NCT03790527

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 13, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

7 months

First QC Date

December 26, 2018

Last Update Submit

August 19, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

CBM training

EXPERIMENTAL

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)

Procedure: CBM training

Sham training

SHAM COMPARATOR

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)

Procedure: Sham training

Interventions

CBM trainingPROCEDURE

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.

CBM training
Sham trainingPROCEDURE

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

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • , 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.
  • , the scores of the Y-IAT(Young-Internet addiction Test) ≥ 50

You may not qualify if:

  • current or history of use of illegal substances and gambling;
  • current or history of psychiatric or neurological illness;
  • current use of psychotropic medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University

Beijing, Beijing Municipality, 100875, China

RECRUITING

Related Publications (3)

  • 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: 25526597BACKGROUND
  • 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: 25639749BACKGROUND
  • 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: 17126289BACKGROUND

MeSH Terms

Conditions

Internet Addiction Disorder

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Jin-Tao Zhang, PhD

    Beijing Normal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Wang, Master

CONTACT

Jin-Tao Zhang, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double blind: both participants and experimenters won't know which group is training group or sham control group.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The investigators assigned subjects to two training groups and collected pre - and post-test data
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

December 26, 2018

First Posted

December 31, 2018

Study Start

April 13, 2019

Primary Completion

October 30, 2019

Study Completion

December 30, 2019

Last Updated

August 21, 2019

Record last verified: 2019-08

Locations