Internet Gaming DisorderNCT04180839
Retrieval-extinction Paradigm on Internet Gaming Disorder
A study testing gaming-related retrieval-extinction and nongaming-related retrieval-extinction in people with Internet Gaming Disorder, run by Beijing Normal University at 1 site in China.
Trial summary
The overall aim of this experimental study is to apply the new paradigm of substance addiction intervention to the study of Internet gaming disorder(IGD) subjects' intervention. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Internet Gaming Disorder
- What is being tested?
- gaming-related retrieval-extinction and nongaming-related retrieval-extinction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2019to 30 Apr 2020
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5 ) recommended diagnosis of Internet gaming disorder : the scores of the 9 items of DSM-5 recommended diagnosis for Internet gaming disorder ≥ 5.
- the scores of the Young-Internet addiction Test ≥ 50
- 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.
Who cannot join
- current or history of use of illegal substances and other addictions;
- 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
jintao Zhang, +861058800728, zhangjintao@bnu.edu.cn
About this study
Official title: Reducing Gaming Cue Reactivity and Behavior Via Retrieval-Extinction Mechanism
The overall aim of this experimental study is to apply the new paradigm of substance addiction intervention to the study of Internet gaming disorder(IGD) subjects' intervention.
Read the detailed description
This study is based on the retrieval-extinction paradigm.As with the efficacy, the experiment aims to test the effect of the retrieval-extinction paradigm on game craving and behave of IGD subjects, so as to provide an empirical basis for the development of effective intervention means of Internet gaming disorder.
- Conditions
- Internet Gaming Disorder
- Being tested
- gaming-related retrieval-extinction, nongaming-related retrieval-extinction
- 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.
gaming-related retrieval-extinctionBehavioural
Also called R-E
During one training session,participants will first view a 5-min retrieval video containing gaming content and then, 10 minutes later, receive 1-hour of extinction training in which they will be administered four sequences of video, picture and in vivo gaming cues.
The whole training includes 2 training sessions. Participants will receive one training session once a day for two consectutive days.
nongaming-related retrieval-extinctionBehavioural
Also called NR-E
During one session,participants will first view a 5-min neutral video and then, 10 minutes later, receive 1-hour of extinction training in which they will be administered four sequences of video, picture and in vivo gaming cues.
The whole procedure includes 2 sessions. Participants will receive one session once a day for two consectutive days.
| Study group | Role | What they receive |
|---|---|---|
| gaming-related retrieval-extinction | Experimental | about 30 individuals with IGD will be randomly assigned to the R-E training group Receives: Behavioral: gaming-related retrieval-extinction |
| nongaming-related retrieval-extinction | Other | about another 30 individuals with IGD will be randomly assigned to the NR-E training group Receives: Behavioral: nongaming-related retrieval-extinction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in gaming craving at cue-reactivity task between the two test sessions
Participants were asked to passively watch three kinds of videos and rate their craving immediately after each video clip using 10-point visual analog scales.The task assesses the severity of cue-induced craving for Internet gaming, with high scores indicating great cue-induced craving.
Measured: baseline , one day after training
Secondary outcomes (2)
Mean Change in gaming Craving
The Brief Questionnaire of gaming Urges questionnaire is a 10-item gaming urge questionnaire with scores ranging from 0 to 10 to assess gaming craving. The questionnaire assesses the severity of craving for Internet gaming behavior, with high scores indicating great craving.
Measured: The questionnaire is given to participants to record their gaming craving at baseline、after the first day of training、after the second day of training、one day after training、1 week and 1 month after tranning respectively
Mean Change in gaming time at baseline、1-Week and 1-month Follow-Up
At the baseline、end of the first week and month test session, participants will receive a diary in which to record the gaming time after the 1-week and 1-month follow-up period.
Measured: A diary is given to participants to record their gaming time at baseline、 1-week and 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start25 Nov 2019
- Primary completion30 Mar 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jintao Zhang, phD, Principal investigator, Beijing Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180839
- Sponsor's protocol ID
- R-E_IGD
- Status last verified
- Dec 2019
- First submitted
- 26 Nov 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we will share individual participant data when required
Publications
Xue YX, Luo YX, Wu P, Shi HS, Xue LF, Chen C, Zhu WL, Ding ZB, Bao YP, Shi J, Epstein DH, Shaham Y, Lu L. A memory retrieval-extinction procedure to prevent drug craving and relapse. Science. 2012 Apr 13;336(6078):241-5. doi: 10.1126/science.1215070.
PubMed 22499948
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Gaming Cue Reactivity and Behavior Via Retrieval-Extinction Mechanism
- ClinicalTrials.gov ID
- NCT04180839
- Acronym / sponsor ID
- R-E_IGD
- Conditions
- Internet Gaming Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Normal UniversityUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 30 Mar 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 29 Nov 2019 (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.
The overall aim of this experimental study is to apply the new paradigm of substance addiction intervention to the study of Internet gaming disorder(IGD) subjects' intervention.
Detailed description
This study is based on the retrieval-extinction paradigm.As with the efficacy, the experiment aims to test the effect of the retrieval-extinction paradigm on game craving and behave of IGD subjects, so as to provide an empirical basis for the development of effective intervention means of Internet gaming disorder.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gaming-related retrieval-extinction | Experimental | Behavioral: gaming-related retrieval-extinctionabout 30 individuals with IGD will be randomly assigned to the R-E training group |
| nongaming-related retrieval-extinction | Other | Behavioral: nongaming-related retrieval-extinctionabout another 30 individuals with IGD will be randomly assigned to the NR-E training group |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5 ) recommended diagnosis of Internet gaming disorder : the scores of the 9 items of DSM-5 recommended diagnosis for Internet gaming disorder ≥ 5.
- the scores of the Young-Internet addiction Test ≥ 50
- 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.
Key exclusion criteria (3 listed)
- current or history of use of illegal substances and other addictions;
- 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 |
|---|---|---|
| gaming-related retrieval-extinctionAlso: R-EDuring one training session,participants will first view a 5-min retrieval video containing gaming content and then, 10 minutes later, receive 1-hour of extinction training in which they will be administered four sequences of video, picture and in vivo gaming cues. The whole training includes 2 training sessions. Participants will receive one training session once a day for two consectutive days. | Behavioural | gaming-related retrieval-extinction |
| nongaming-related retrieval-extinctionAlso: NR-EDuring one session,participants will first view a 5-min neutral video and then, 10 minutes later, receive 1-hour of extinction training in which they will be administered four sequences of video, picture and in vivo gaming cues. The whole procedure includes 2 sessions. Participants will receive one session once a day for two consectutive days. | Behavioural | nongaming-related retrieval-extinction |
Primary outcome
Mean Change in gaming craving at cue-reactivity task between the two test sessions
Time frame: baseline , one day after training
Participants were asked to passively watch three kinds of videos and rate their craving immediately after each video clip using 10-point visual analog scales.The task assesses the severity of cue-induced craving for Internet gaming, with high scores indicating great cue-induced craving.
2 secondary outcomes
Mean Change in gaming Craving
Time frame: The questionnaire is given to participants to record their gaming craving at baseline、after the first day of training、after the second day of training、one day after training、1 week and 1 month after tranning respectively
Mean Change in gaming time at baseline、1-Week and 1-month Follow-Up
Time frame: A diary is given to participants to record their gaming time at baseline、 1-week and 1-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Background: PubMed 22499948Xue YX, Luo YX, Wu P, Shi HS, Xue LF, Chen C, Zhu WL, Ding ZB, Bao YP, Shi J, Epstein DH, Shaham Y, Lu L. A memory retrieval-extinction procedure to prevent drug craving and relapse. Science. 2012 Apr 13;336(6078):241-5. doi: 10.1126/science.1215070.
- Individual participant dataSharing planned: Yes. we will share individual participant data when required
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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.
jintao 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 gaming-related retrieval-extinction and nongaming-related retrieval-extinction 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 3 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 5 Dec 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. 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 Ziliang Wang, Master (+8618395949625, wangziliang201@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in gaming craving at cue-reactivity task between the two test sessions (time frame: baseline , one day after training). 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 NCT04180839, which also lists 1 linked publication.
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 5 Dec 2019.