A Study for the Disrupted Interpersonal Interaction Among Gaming Disorder Individuals and Treatment

NCT06208358 | Recruiting

• 1 other identifier: NZhong-006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Aiming at the major problems of unclear brain mechanism of gaming disorder and lack of effective assessment intervention tools, this project started by exploring the brain mechanism of abnormal interpersonal interaction and cognitive control deficit promoting and accelerating the development of gaming disorder, adopted a prospective cohort study design, combined with multi-modal brain functional imaging, cognitive function, social psychological assessment, and other means. To clarify the brain mechanism and outcome of gaming disorder. Based on the preliminary stage, for high-risk groups, risky gaming behavior, gaming disorder layout hierarchical multidimensional assessment intervention system, using science education, brief intervention, social psychological intervention, neural regulation, cognitive rehabilitation training, mobile medical treatment, and other ways, stratification and stage, early identification, prevention and treatment combination, accurate intervention to comprehensively reduce the occurrence and development of gaming disorder.

Conditions

Gaming Disorder

Outcome Measures

Primary Outcomes (3)

• cue-induced craving

  Craving was assessed by visual analog scales (VAS), with 0 mm being "no craving"and 100 mm representing "most craving ever experienced for gaming ".

  Two weeks,Four weeks

• inter-brain synchronization (IBS)

  IBS was assessed by fNIRS hyperscanning with WTC analysis. A higher WTC refers to a higher level of inter-brain synchronization.

  Two weeks,Four weeks

• cognition measures

  Chinese version of the CogState Battery was used to assess cognitive function. We selected five tasks: Two back task (working memory), Continuous paired association task (visual spatial working memory), Groton maze learning task (error monitoring), social emotional cognition (social emotional cognition) and Detection task (processing speed) which were displayed on a green screen with standardized instructions before each task beginning.The accuracy in Two back task, social emotional cognition, and the speed in Detection task, and total errors in Continuous paired association task, Groton maze learning task are our focus.

  Four weeks

Study Arms (2)

real tACS

ACTIVE COMPARATOR

Device: Transcranial Alternating Current Stimulation In recent years, transcranial alternating current stimulation (tACS) has been widely used to regulate brain neural activity and improve cognitive function because of its non-invasive, portable, and easy-to-operate characteristics. tACS can effectively improve 9 cognitive functions, including visual attention, working memory, long-term memory, executive control, fluid intelligence, learning, decision-making, motor learning, and motor memory

Device: tACS

sham tACS

SHAM COMPARATOR

Device: Transcranial Alternating Current Stimulation In recent years, transcranial alternating current stimulation (tACS) has been widely used to regulate brain neural activity and improve cognitive function because of its non-invasive, portable, and easy-to-operate characteristics. tACS can effectively improve 9 cognitive functions, including visual attention, working memory, long-term memory, executive control, fluid intelligence, learning, decision-making, motor learning, and motor memory

Device: tACS

Interventions

tACS DEVICE

We aim to use tACS devices to improve the disrupted interpersonal interaction among gaming disorder individuals.

real tACS; sham tACS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• (1)Clinical diagnosis of severe Gaming Disorder defined in the ICD-11; (2)Normal hearing and vision, or within normal range after correction;

You may not qualify if:

• (1) Clinical diagnosis of mental health disorders other than GD defined in the ICD-11 in the past 5 years；(2) Suffering from diseases that affect cognitive function (such as cerebrovascular diseases) ; (3) Schizophrenia, bipolar disorder, depression or other Axis I disorder of DSM-V criteria;(4)any contraindication for tACS intervention.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

CN (1)