Internet Gaming DisorderNCT02550405
The Behavioral and Brain Mechanism of IGD
A study testing Craving behavioral intervention in people with Internet Gaming Disorder, run by Beijing Normal University at 1 site in China.
Trial summary
This project aims to investigate whether anodal tDCS of dlPFC enhances cognitive regulation over craving an emotions. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Internet Gaming Disorder
- What is being tested?
- Craving behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Dec 2015
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- a score of 67 or higher on the CIAS;
- engagement in Internet gaming for over 14 hours per week for a minimum of one year; and
- reporting of Internet gaming as their primary online activity;
- a score < 60 on the CIAS;
- never having spent more than 2 hours per week engaged in Internet gaming
Who cannot join
- for all participants:
- current or history of use of illegal substances and gambling;
- current or history of psychiatric or neurological illness; and
- current use of psychotropic medications
Trial locations and contacts
1 site in 1 country.
China1 site
State Key Laboratory of Cognitive Neuroscience and Learning
Beijing, Beijing Municipality, 100875
About this study
Official title: The Behavioral and Brain Mechanism of Internet Gaming Disorder
This project aims to investigate whether anodal tDCS of dlPFC enhances cognitive regulation over craving an emotions.
- Conditions
- Internet Gaming Disorder
- Being tested
- Craving behavioral intervention
- 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.
Craving behavioral interventionBehavioural
Also called CBI
The CBI was given once a week for 6 weeks, conducted by four therapists. A pair of therapists was randomly assigned to a CBI+ group. Each session included 5 parts in 2.5-3 hours: warming-up exercise, discussion about the homework from the last session, main structured activity, brief summary, and the homework assignment. There were 6 sessions with each focused on a topic: recognize craving and its relationship with IGD; reduce craving through ameliorating the salience of cues and irrational beliefs, withdrawal symptoms and other negative affects; enhance self-monitoring and control for craving through time management training; relieve fulfillment of psychological needs through Internet use and attenuate the relation between craving and gaming behaviors through coping skill training
| Study group | Role | What they receive |
|---|---|---|
| Craving behavioral intervention | Experimental | The craving behavioral intervention (CBI) was developed based on the framework of craving, combining with behavior intervention (Dong and Potenza, 2014), and conducted among individuals with IGD. Receives: Behavioral: Craving behavioral intervention |
| Control | No intervention | The control group were individuals with Internet gaming disorder who did not receive any intervention but were scanned twice with the similar interval period as experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain resting state functional connectivity as measured by fMRI
voxel-wise, ROI-wise, and ICA analyses
Measured: Detecting changes between two different time points (baseline and 6 weeks)
Brain activation during a cue-induced craving task as measured by fMRI
A paradigm using addictive pictures to induce craving
Measured: Detecting changes between two different time points (baseline and 6 weeks)
Secondary outcomes (7)
Brain activation during the Cups task as measured by fMRI
Cups task measuring risky decision-making related to potential gains and losses separately
Measured: Detecting changes between two different time points (baseline and 6 weeks)
Brain activation during the mixed gambling task tasks as measured by fMRI
The mix gambling task measuring decision-making related to loss aversion
Measured: Detecting changes between two different time points (baseline and 6 weeks)
Brain structure as measured by structural MRI
comparing gray matter and white matter differences between individuals with IGD and healthy controls.
Measured: Detecting changes between two different time points (baseline and 6 weeks)
IGD severity measured by Chen Internet addiction scale
a 26-item 4-point Likert scale
Measured: Detecting changes between two different time points (baseline and 6 weeks)
Craving as measured by brief questionnaire of Internet (gaming) craving
a 8-item 7-point Likert scale
Measured: Detecting changes between two different time points (baseline and 6 weeks)
Impulsivity as measured by Barratt impulsive scale (BIS-II)
a 30-item 4-point Likert scale
Measured: Detecting changes between two different time points (baseline and 6 weeks)
weekly online (gaming) time
self-report,in hours
Measured: Detecting changes between two different time points (baseline and 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startMar 2012
- Primary completionDec 2014
- Study completionDec 2015
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jintao, zhang, Beijing Normal University
- Investigators
- XiaoYi Fang, PhD, Study chair, Institute of Developmental Psychology, Beijing Normal UniversityJinTao Zhang, PhD, Study chair, State Key Laboratory of Cognitive Neuroscience and LearningCuiCui Xia, MEd, Principal investigator, Institute of Developmental Psychology, Beijing Normal UniversityLinYuan Deng, PhD, Principal investigator, Faculty of Education Beijing Normal UniversityLu Liu, BS, Principal investigator, Institute of Developmental Psychology, Beijing Normal UniversityBen Liu, BSM, Principal investigator, State Key Laboratory of Cognitive Neuroscience and LearningShanShan Ma, BS, Principal investigator, State Key Laboratory of Cognitive Neuroscience and LearningYuanWei Yao, BS, Principal investigator, State Key Laboratory of Cognitive Neuroscience and Learning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550405
- Sponsor's protocol ID
- BeijingNormalU
- Status last verified
- Dec 2018
- First submitted
- 10 Sep 2015
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dong G, Potenza MN. A cognitive-behavioral model of Internet gaming disorder: theoretical underpinnings and clinical implications. J Psychiatr Res. 2014 Nov;58:7-11. doi: 10.1016/j.jpsychires.2014.07.005. Epub 2014 Jul 17.
PubMed 25062755Liu L, Yao YW, Li CR, Zhang JT, Xia CC, Lan J, Ma SS, Zhou N, Fang XY. The Comorbidity Between Internet Gaming Disorder and Depression: Interrelationship and Neural Mechanisms. Front Psychiatry. 2018 Apr 23;9:154. doi: 10.3389/fpsyt.2018.00154. eCollection 2018.
PubMed 29740358Deng LY, Liu L, Xia CC, Lan J, Zhang JT, Fang XY. Craving Behavior Intervention in Ameliorating College Students' Internet Game Disorder: A Longitudinal Study. Front Psychol. 2017 Apr 10;8:526. doi: 10.3389/fpsyg.2017.00526. eCollection 2017.
PubMed 28443046
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Behavioral and Brain Mechanism of Internet Gaming Disorder
- ClinicalTrials.gov ID
- NCT02550405
- Acronym / sponsor ID
- BeijingNormalU
- Conditions
- Internet Gaming Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Beijing Normal UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Sep 2015 (estimated)
- 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.
This project aims to investigate whether anodal tDCS of dlPFC enhances cognitive regulation over craving an emotions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Craving behavioral intervention | Experimental | Behavioral: Craving behavioral interventionThe craving behavioral intervention (CBI) was developed based on the framework of craving, combining with behavior intervention (Dong and Potenza, 2014), and conducted among individuals with IGD. |
| Control | No intervention | –The control group were individuals with Internet gaming disorder who did not receive any intervention but were scanned twice with the similar interval period as experimental group. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
Key exclusion criteria (4 listed)
- for all participants:
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 |
|---|---|---|
| Craving behavioral interventionAlso: CBIThe CBI was given once a week for 6 weeks, conducted by four therapists. A pair of therapists was randomly assigned to a CBI+ group. Each session included 5 parts in 2.5-3 hours: warming-up exercise, discussion about the homework from the last session, main structured activity, brief summary, and the homework assignment. There were 6 sessions with each focused on a topic: recognize craving and its relationship with IGD; reduce craving through ameliorating the salience of cues and irrational beliefs, withdrawal symptoms and other negative affects; enhance self-monitoring and control for craving through time management training; relieve fulfillment of psychological needs through Internet use and attenuate the relation between craving and gaming behaviors through coping skill training | Behavioural | Craving behavioral intervention |
Primary outcome
Brain resting state functional connectivity as measured by fMRI
Time frame: Detecting changes between two different time points (baseline and 6 weeks)
voxel-wise, ROI-wise, and ICA analyses
Brain activation during a cue-induced craving task as measured by fMRI
Time frame: Detecting changes between two different time points (baseline and 6 weeks)
A paradigm using addictive pictures to induce craving
7 secondary outcomes
Brain activation during the Cups task as measured by fMRI
Time frame: Detecting changes between two different time points (baseline and 6 weeks)
Brain activation during the mixed gambling task tasks as measured by fMRI
Time frame: Detecting changes between two different time points (baseline and 6 weeks)
Brain structure as measured by structural MRI
Time frame: Detecting changes between two different time points (baseline and 6 weeks)
IGD severity measured by Chen Internet addiction scale
Time frame: Detecting changes between two different time points (baseline and 6 weeks)
Craving as measured by brief questionnaire of Internet (gaming) craving
Time frame: Detecting changes between two different time points (baseline and 6 weeks)
Impulsivity as measured by Barratt impulsive scale (BIS-II)
Time frame: Detecting changes between two different time points (baseline and 6 weeks)
weekly online (gaming) time
Time frame: Detecting changes between two different time points (baseline and 6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Background: PubMed 25062755Dong G, Potenza MN. A cognitive-behavioral model of Internet gaming disorder: theoretical underpinnings and clinical implications. J Psychiatr Res. 2014 Nov;58:7-11. doi: 10.1016/j.jpsychires.2014.07.005. Epub 2014 Jul 17.
- Derived from this study: PubMed 29740358Liu L, Yao YW, Li CR, Zhang JT, Xia CC, Lan J, Ma SS, Zhou N, Fang XY. The Comorbidity Between Internet Gaming Disorder and Depression: Interrelationship and Neural Mechanisms. Front Psychiatry. 2018 Apr 23;9:154. doi: 10.3389/fpsyt.2018.00154. eCollection 2018.
- Derived from this study: PubMed 28443046Deng LY, Liu L, Xia CC, Lan J, Zhang JT, Fang XY. Craving Behavior Intervention in Ameliorating College Students' Internet Game Disorder: A Longitudinal Study. Front Psychol. 2017 Apr 10;8:526. doi: 10.3389/fpsyg.2017.00526. eCollection 2017.
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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.
XiaoYi Fang, PhD study chair
Institute of Developmental Psychology, Beijing Normal University
JinTao Zhang, PhD study chair
State Key Laboratory of Cognitive Neuroscience and Learning
CuiCui Xia, MEd principal investigator
Institute of Developmental Psychology, 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 Craving behavioral intervention 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 13 Dec 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain resting state functional connectivity as measured by fMRI (time frame: Detecting changes between two different time points (baseline and 6 weeks)). The study lists 2 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 NCT02550405, 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 13 Dec 2018.