Internet Gaming DisorderNCT06165549
Light Therapy for Internet Gaming Disorder
A study testing Light therapy and Emotion Bias Modification Training in people with Internet Gaming Disorder and Light Therapy, run by Jinan University Guangzhou at 2 sites in China.
Trial summary
This project aims to investigate (1) the efficacy of light therapy on internet gaming disorder (IGD); (2) the underlying neural mechanisms of such efficacy Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Internet Gaming Disorder, Light Therapy
- What is being tested?
- Light therapy and Emotion Bias Modification Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 2 sitesChina
- Study dates
- 16 Dec 2023to 15 Jun 2024
- 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 28 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 Young-Internet addiction Test ≥ 50;
- playing internet games ≥15 h/week for ≥1 year
Who cannot join
- current or history of psychiatric or neurological illness;
- current or history of use of illegal substances and other addictions;
- current use of psychotropic medications ;
- any history of head trauma, presence of metal in the body or other contraindication to functional MRI scanning;
- photosensitivity disorders, such as systemic lupus erythematosus and chronic actinic dermatitis.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Jinan University
Guangdong, Guangzhou, 510000
South China Normal University
Guangzhou, Guangdong, 510000
About this study
Official title: A Randomized Controlled Double-Blind Trial of Light Therapy for Internet Gaming Disorder
This project aims to investigate (1) the efficacy of light therapy on internet gaming disorder (IGD); (2) the underlying neural mechanisms of such efficacy
- Conditions
- Internet Gaming Disorder, Light Therapy
- Being tested
- Light therapy, Light placebo therapy, Emotion Bias Modification 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.
Light therapyOther
The light therapy will be administered by custom-made light boxes (LED) with adjustable brightness. The light intensity will be set at 5000 Lux. The intervention will consist of daily exposure for 30 minutes in the morning. The whole intervention includes 14 days.
Light placebo therapyOther
The light placebo intervention will be administered by custom-made light boxes (LED) with adjustable brightness. The light intensity will be set at less than 200 Lux. The intervention will consist of daily exposure for 30 minutes in the morning. The whole intervention includes 14 days.
Emotion Bias Modification TrainingOther
The training aims at associating gaming pictures with negative words and pictures of healthy activities with positive words. Gaming pictures are always presented with a pair of negative words. Pictures of healthy activities are always presented with a pair of positive words. Each picture is presented with a fixed pair of words. Participants will be instructed to select one word to get the most monetary reward. Specifically, selecting a fixed word of the word-pair will be associated with a high probability (eighty percent) of getting a monetary reward and a low probability (twenty percent) of no reward, and probabilities will be reversed for the other word. Each training run will comprise 100 gaming picture trials and 100 healthy-activity picture trials, presented in a pseudo-randomized order. Participants will receive two training runs every day. The whole training includes 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Light therapy | Experimental | about 30 individuals with internet gaming disorder will be randomly assigned to the light therapy group Receives: Other: Light therapy |
| Light placebo | Placebo comparator | about 30 individuals with internet gaming disorder will be randomly assigned to the light placebo group Receives: Other: Light placebo therapy |
| EABM training group | Other | about 30 individuals with internet gaming disorder will be randomly assigned to the EABM training group Receives: Other: Emotion Bias Modification Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in IGD severity
The scores of IGD severity will be assessed with the internet addiction test for internet gaming disorder.
Measured: baseline , within one day after intervention, and 4-week after intervention
changes in weekly gaming time
weekly gaming time will be recorded by Software.
Measured: baseline and within 1 day after intervention
changes in withdrawal symptoms
The scores of withdrawal symptoms will be assessed with the mood and physical symptoms scale.
Measured: baseline and within 1 day after intervention
change of BOLD signals
Task-based fMRI and resting state fMRI.
Measured: baseline and within 1 day after intervention
changes in craving
Craving will be assessed using a Visual Analog Scale during a cue-reactivity task.
Measured: baseline and within 1 day after intervention
Secondary outcomes (6)
changes in gaming-related compulsive behaviors
The scores of gaming-related compulsive behaviors will be assessed with the Yale-Brown Obsessive-Compulsive Scale modified for internet gaming disorder.
Measured: baseline and within 1 day after intervention
changes in gaming-related compulsive thoughts
The scores of gaming-related compulsive thoughts will be assessed with the Yale-Brown Obsessive-Compulsive Scale modified for internet gaming disorder.
Measured: baseline and within 1 day after intervention
changes in the quality and patterns of sleep
The scores of the quality and patterns of sleep will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
Measured: baseline and within 1 day after intervention
changes in the severity of depression
The scores of the severity of depression will be assessed with the Beck Depression Inventory（BDI）
Measured: baseline and within 1 day after intervention
changes in the severity of anxiety
The scores of the severity of anxiety will be assessed with the Beck Anxiety Inventory (BAI)
Measured: baseline and within 1 day after intervention
changes in the severity of two emotion regulation strategies, cognitive reappraisal and expressive suppression
The scores of emotion regulation strategies will be assessed with the Emotion Regulation Questionnaire (ERQ)
Measured: baseline and within 1 day after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start16 Dec 2023
- Primary completion15 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinan University Guangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Tao, Jinan University Guangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165549
- Sponsor's protocol ID
- Internet Gaming Disorder
- Status last verified
- Jul 2024
- First submitted
- 27 Nov 2023
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Double-Blind Trial of Light Therapy for Internet Gaming Disorder
- ClinicalTrials.gov ID
- NCT06165549
- Acronym / sponsor ID
- Internet Gaming Disorder
- Conditions
- Internet Gaming Disorder, Light Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Jinan University GuangzhouUniversity, hospital or other
- Study start
- 16 Dec 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 11 Dec 2023 (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.
This project aims to investigate (1) the efficacy of light therapy on internet gaming disorder (IGD); (2) the underlying neural mechanisms of such efficacy
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Light therapy | Experimental | Other: Light therapyabout 30 individuals with internet gaming disorder will be randomly assigned to the light therapy group |
| Light placebo | Placebo comparator | Other: Light placebo therapyabout 30 individuals with internet gaming disorder will be randomly assigned to the light placebo group |
| EABM training group | Other | Other: Emotion Bias Modification Trainingabout 30 individuals with internet gaming disorder will be randomly assigned to the EABM training group |
Who may qualify
- Ages
- 18 to 28 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 Young-Internet addiction Test ≥ 50;
- playing internet games ≥15 h/week for ≥1 year
Key exclusion criteria (5 listed)
- current or history of psychiatric or neurological illness;
- current or history of use of illegal substances and other addictions;
- current use of psychotropic medications ;
- any history of head trauma, presence of metal in the body or other contraindication to functional MRI scanning;
- photosensitivity disorders, such as systemic lupus erythematosus and chronic actinic dermatitis.
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 |
|---|---|---|
| Light therapyThe light therapy will be administered by custom-made light boxes (LED) with adjustable brightness. The light intensity will be set at 5000 Lux. The intervention will consist of daily exposure for 30 minutes in the morning. The whole intervention includes 14 days. | Other | Light therapy |
| Light placebo therapyThe light placebo intervention will be administered by custom-made light boxes (LED) with adjustable brightness. The light intensity will be set at less than 200 Lux. The intervention will consist of daily exposure for 30 minutes in the morning. The whole intervention includes 14 days. | Other | Light placebo |
| Emotion Bias Modification TrainingThe training aims at associating gaming pictures with negative words and pictures of healthy activities with positive words. Gaming pictures are always presented with a pair of negative words. Pictures of healthy activities are always presented with a pair of positive words. Each picture is presented with a fixed pair of words. Participants will be instructed to select one word to get the most monetary reward. Specifically, selecting a fixed word of the word-pair will be associated with a high probability (eighty percent) of getting a monetary reward and a low probability (twenty percent) of no reward, and probabilities will be reversed for the other word. Each training run will comprise 100 gaming picture trials and 100 healthy-activity picture trials, presented in a pseudo-randomized order. Participants will receive two training runs every day. The whole training includes 14 days. | Other | EABM training group |
Primary outcome
changes in IGD severity
Time frame: baseline , within one day after intervention, and 4-week after intervention
The scores of IGD severity will be assessed with the internet addiction test for internet gaming disorder.
changes in weekly gaming time
Time frame: baseline and within 1 day after intervention
weekly gaming time will be recorded by Software.
changes in withdrawal symptoms
Time frame: baseline and within 1 day after intervention
The scores of withdrawal symptoms will be assessed with the mood and physical symptoms scale.
change of BOLD signals
Time frame: baseline and within 1 day after intervention
Task-based fMRI and resting state fMRI.
changes in craving
Time frame: baseline and within 1 day after intervention
Craving will be assessed using a Visual Analog Scale during a cue-reactivity task.
6 secondary outcomes
changes in gaming-related compulsive behaviors
Time frame: baseline and within 1 day after intervention
changes in gaming-related compulsive thoughts
Time frame: baseline and within 1 day after intervention
changes in the quality and patterns of sleep
Time frame: baseline and within 1 day after intervention
changes in the severity of depression
Time frame: baseline and within 1 day after intervention
changes in the severity of anxiety
Time frame: baseline and within 1 day after intervention
changes in the severity of two emotion regulation strategies, cognitive reappraisal and expressive suppression
Time frame: baseline and within 1 day after intervention
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 24 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light therapy and Emotion Bias Modification Training in people with Internet Gaming Disorder and Light Therapy, run by Jinan University Guangzhou at 2 sites 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 5 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 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
changes in IGD severity (time frame: baseline , within one day after intervention, and 4-week after intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2024.