- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06165549
Light Therapy for Internet Gaming Disorder
December 25, 2023 updated by: Qian Tao, Jinan University Guangzhou
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Qian Tao, phD
- Phone Number: +8618818879657
- Email: hhyang12138@163.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Recruiting
- South China Normal University
-
Contact:
- Qian Tao, phD
- Phone Number: 18818879657
- Email: taoqian16@jnu.edu.cn
-
-
Guangzhou
-
Guangdong, Guangzhou, China, 510000
- Recruiting
- Jinan University
-
Contact:
- Qian Tao, phD
- Phone Number: 18818879657
- Email: taoqian16@jnu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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 ≥20 h/week for ≥1 year
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Light therapy
about 30 individuals with internet gaming disorder will be randomly assigned to the light therapy group
|
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±5 days.
|
Placebo Comparator: Light placebo
about 30 individuals with internet gaming disorder will be randomly assigned to the light placebo group
|
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±5 days.
|
Other: EABM training group
about 30 individuals with internet gaming disorder will be randomly assigned to the EABM training group
|
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, in response to each gaming picture, selecting one word will have a 70% chance to get a monetary reward and the other word will have a 30% chance to get a monetary reward.
A similar rationale applies to the pictures of healthy activities.
The reward setting will help consolidate target associations.Each training session includes 300 times/trials of each type of association, presented in pseudorandom way.
The whole training includes 14±5 days.
Participants will receive one training session every day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in gaming-related compulsive thoughts
Time Frame: baseline and within 1 day after intervention
|
The scores of gaming-related compulsive thoughts will be assessed with the Yale-Brown Obsessive-Compulsive Scale modified for internet gaming disorder.
|
baseline and within 1 day after intervention
|
changes in gaming-related compulsive behaviors
Time Frame: baseline and within 1 day after intervention
|
The scores of gaming-related compulsive behaviors will be assessed with the Yale-Brown Obsessive-Compulsive Scale modified for internet gaming disorder.
|
baseline and within 1 day after intervention
|
changes in IGD severity
Time Frame: baseline , within one day after intervention, and one month after intervention
|
The scores of IGD severity will be assessed with the internet addiction test for internet gaming disorder.
|
baseline , within one day after intervention, and one month after intervention
|
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.
|
baseline and within 1 day after intervention
|
changes in weekly gaming time
Time Frame: baseline and within 1 day after intervention
|
weekly gaming time will be recorded by Software.
|
baseline and within 1 day after intervention
|
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.
|
baseline and within 1 day after intervention
|
changes in inhibition
Time Frame: baseline and within 1 day after intervention
|
Go NoGo task
|
baseline and within 1 day after intervention
|
change of BOLD signals
Time Frame: baseline and within 1 day after intervention
|
Task-based fMRI and resting state fMRI.
|
baseline and within 1 day after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in risk-taking tendencies
Time Frame: baseline and within 1 day after intervention
|
The balloon analogue risk task (BART)
|
baseline and within 1 day after intervention
|
changes in the quality and patterns of sleep
Time Frame: baseline and within 1 day after intervention
|
The scores of the quality and patterns of sleep will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
|
baseline and within 1 day after intervention
|
changes in the severity of depression
Time Frame: baseline and within 1 day after intervention
|
The scores of the severity of depression will be assessed with the Beck Depression Inventory(BDI)
|
baseline and within 1 day after intervention
|
changes in the severity of anxiety
Time Frame: baseline and within 1 day after intervention
|
The scores of the severity of anxiety will be assessed with the Beck Anxiety Inventory (BAI)
|
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
|
The scores of emotion regulation strategies will be assessed with the Emotion Regulation Questionnaire (ERQ)
|
baseline and within 1 day after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 16, 2023
Primary Completion (Estimated)
April 30, 2024
Study Completion (Estimated)
August 31, 2024
Study Registration Dates
First Submitted
November 27, 2023
First Submitted That Met QC Criteria
November 27, 2023
First Posted (Actual)
December 11, 2023
Study Record Updates
Last Update Posted (Estimated)
December 27, 2023
Last Update Submitted That Met QC Criteria
December 25, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Internet Gaming Disorder
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Internet Gaming Disorder
-
Region SkaneLund UniversityRecruiting
-
Çağtay MadenCompletedSedentary Behavior | Gaming DisorderTurkey
-
Assiut UniversityNot yet recruitingInternet Gaming Disorder | Internet Addiction
-
UConn HealthNational Institute on Drug Abuse (NIDA)Completed
-
Beijing Normal UniversityCompleted
-
Beijing Normal UniversityCompleted
-
Region SkaneRecruitingInternet Gaming Disorder | Internet AddictionSweden
-
Chinese University of Hong KongRecruiting
-
Beijing Normal UniversityCompletedInternet Gaming DisorderChina
-
Beijing Normal UniversityUnknownInternet Gaming DisorderChina
Clinical Trials on Light therapy
-
University of HoustonCompleted
-
University of Colorado, BoulderRecruiting
-
University Hospital, Strasbourg, FranceCompleted
-
Uppsala UniversityUppsala County Council, SwedenCompletedDelayed Sleep Phase SyndromeSweden
-
Northwestern UniversityRecruitingAging | Peripheral Vascular Disease | Peripheral Artery Disease | Walking, DifficultyUnited States
-
Chinese University of Hong KongRecruiting
-
Massachusetts General HospitalLiteCure LLCCompletedDepression | Major Depressive DisorderUnited States
-
Medical University of ViennaCompletedSeasonal Affective DisorderAustria
-
Universidade Federal de Sao CarlosFundação de Amparo à Pesquisa do Estado de São Paulo; Centro de Pequisas de...Completed
-
The Netherlands Cancer InstituteDutch Cancer SocietyCompletedHodgkin Lymphoma | Diffuse Large B Cell LymphomaNetherlands