Internet Gaming DisorderCBM&IGDNCT03790527
Cognitive Bias Modification Training on Internet Gaming Disorder
A study testing CBM training in people with Internet Gaming Disorder, run by Beijing Normal University at 1 site in China.
Trial summary
To investigate whether and how the CBM training will alleviate the symptoms of addiction in Internet gaming disorders. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men only
- Conditions the study is for
- Internet Gaming Disorder
- What is being tested?
- CBM training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2019to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- current or history of use of illegal substances and gambling;
- current or history of psychiatric or neurological illness;
- current use of psychotropic medications.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University
Beijing, Beijing Municipality, 100875
Jin-Tao Zhang, +861058800728, zhangjintao@bnu.edu.cn
About this study
Official title: A Research on the Mechanism of Cognitive Bias Modification Training in Internet Gaming Disorders.
To investigate whether and how the CBM training will alleviate the symptoms of addiction in Internet gaming disorders.
Read the 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.
- Conditions
- Internet Gaming Disorder
- Being tested
- CBM training, Sham training
- Medical subject headings
- Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBM trainingProcedure or surgery
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 trainingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Procedure: Sham training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 30- 60 minutes after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start13 Apr 2019
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Internet Gaming DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators assigned subjects to two training groups and collected pre - and post-test data
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-tao Zhang, Beijing Normal University
- Investigators
- Jin-Tao Zhang, PhD, Principal investigator, Beijing Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790527
- Sponsor's protocol ID
- IGD_CBM intervention
- Acronym
- CBM&IGD
- Status last verified
- Aug 2019
- First submitted
- 26 Dec 2018
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 25526597Wiers 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.
PubMed 25639749Rinck 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.
PubMed 17126289
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Research on the Mechanism of Cognitive Bias Modification Training in Internet Gaming Disorders.
- ClinicalTrials.gov ID
- NCT03790527
- Acronym / sponsor ID
- CBM&IGD / IGD_CBM intervention
- Conditions
- Internet Gaming Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Beijing Normal UniversityUniversity, hospital or other
- Study start
- 13 Apr 2019 (actual)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The investigators assigned subjects to two training groups and collected pre - and post-test data
| Arm | Type | Receives |
|---|---|---|
| CBM training | Experimental | Procedure: CBM trainingparticipants 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) |
| Sham training | Sham comparator | Procedure: Sham trainingparticipants 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) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- current or history of use of illegal substances and gambling;
- current or history of psychiatric or neurological illness;
- current use of psychotropic medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBM trainingparticipants 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. | Procedure or surgery | CBM training |
| Sham trainingparticipants 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. | Procedure or surgery | Sham training |
Primary outcome
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.
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
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Background: PubMed 25526597Wiers 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.
- Background: PubMed 25639749Wiers 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.
- Background: PubMed 17126289Rinck 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Tao Zhang, PhD principal investigator
Beijing Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBM training in people with Internet Gaming Disorder, run by Beijing Normal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rui Wang, Master (+8618810315922, 851006286@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral outcome (time frame: 60- 80 minutes after training). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03790527, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.