NCT06165549

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

December 16, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

November 27, 2023

Last Update Submit

July 22, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • changes in IGD severity

    The scores of IGD severity will be assessed with the internet addiction test for internet gaming disorder.

    baseline , within one day after intervention, and 4-week after intervention

  • changes in weekly gaming time

    weekly gaming time will be recorded by Software.

    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.

    baseline and within 1 day after intervention

  • change of BOLD signals

    Task-based fMRI and resting state fMRI.

    baseline and within 1 day after intervention

  • changes in craving

    Craving will be assessed using a Visual Analog Scale during a cue-reactivity task.

    baseline and within 1 day after intervention

Secondary Outcomes (6)

  • changes in gaming-related compulsive behaviors

    baseline and within 1 day after intervention

  • changes in gaming-related compulsive thoughts

    baseline and within 1 day after intervention

  • changes in the quality and patterns of sleep

    baseline and within 1 day after intervention

  • changes in the severity of depression

    baseline and within 1 day after intervention

  • changes in the severity of anxiety

    baseline and within 1 day after intervention

  • +1 more secondary outcomes

Study Arms (3)

Light therapy

EXPERIMENTAL

about 30 individuals with internet gaming disorder will be randomly assigned to the light therapy group

Other: Light therapy

Light placebo

PLACEBO COMPARATOR

about 30 individuals with internet gaming disorder will be randomly assigned to the light placebo group

Other: Light placebo therapy

EABM training group

OTHER

about 30 individuals with internet gaming disorder will be randomly assigned to the EABM training group

Other: Emotion Bias Modification Training

Interventions

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 therapy

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.

Light placebo

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.

EABM training group

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

South China Normal University

Guangzhou, Guangdong, 510000, China

Location

Jinan University

Guangdong, Guangzhou, 510000, China

Location

MeSH Terms

Conditions

Internet Addiction Disorder

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Tao

Study Record Dates

First Submitted

November 27, 2023

First Posted

December 11, 2023

Study Start

December 16, 2023

Primary Completion

June 15, 2024

Study Completion

June 15, 2024

Last Updated

July 24, 2024

Record last verified: 2024-07

Locations