The American Psychiatric Association (APA) included internet game disorder (IGD) in section III of the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) on the condition that it guaranteed more clinical research and experience. The World Health Organization (WHO) also included Game Disorder (GD) in the 11th final revision of the International Classification of Diseases (ICD-11) and recently recognized it as a diagnosis code. This study aims to compare clinical characteristics and gaming behavior patterns between the IGD diagnosis criteria proposed by the DSM-5 and the GD diagnosis criteria proposed by the ICD-11 based on clinical cohort data (c-CURE: clinic-Cohort for Understanding of internet addiction Rescue factors in Early life) obtained in the Republic of Korea. Psychologists and psychiatrists conducted semi-structured interviews with children/adolescents and their caregivers to identify IGD (Diagnostic Interview for Internet, Game, SNS, etc. Addiction, DIA), and comorbid psychiatric disorders (Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version-Korean version, K-SADS-PL). The cohort was divided into three IGD diagnosis groups (Normal, DSM5, DSM5 + ICD11) based on DSM-5 and ICD-11 diagnosis criteria. Internet usage pattern and addiction characteristics and psychiatric comorbidities were compared among the three IGD diagnosis groups. The Normal group consisted of 115 subjects, the DSM5 group contained 61 subjects, and the DSM5 + ICD11 group amounted to 12 subjects. The DSM5 + ICD11 group had a lower age of starting use of Internet/games/smartphones than other groups and the average time of Internet/game/smartphone use during weekdays/weekends was the highest. Also, in the eight items scored, excluding ‘deceiving’ and ‘craving’, the rate of threshold was highest in the DSM5 + ICD11 group, followed by the DSM5 group and the Normal group. On the other hand, ‘deceiving’ and ‘craving’ were the highest in DSM5, followed by DSM5 + ICD11 and Normal. The DSM5 + ICD11 group had significantly higher rates of depressive disorder, oppositional defiant disorder (ODD) and conduct disorder (CD) compared to other groups. This study provides implications for the clinical characteristics of IGD diagnosis in the field by comparing the DSM-5 IGD diagnosis criteria with the ICD-11 GD diagnosis criteria. Furthermore, this study provides empirical evidence that ICD-11 GD emphasizes serious symptoms such as functional impairment caused by excessive Internet/game/smartphone use over a long time, and it supports the validity of the ICD-11 GD diagnosis.

Background: Smoking cessation remains a global challenge, with traditional treatments showing limited long-term success due to low adherence and accessibility issues. Digital therapeutics, such as mobile apps and virtual reality (VR)–based interventions, could offer innovative solutions for smoking cessation treatment. NICO-THERA is a digital therapeutic program integrating cognitive behavioral therapy (CBT) and motivational enhancement therapy (MET) to address nicotine dependence. Objective: This study aims to evaluate the safety and efficacy of NICO-THERA, a digital therapeutic intervention combining VR and mobile apps, for supporting smoking cessation among individuals with nicotine dependence. The primary focus was on smoking abstinence, nicotine dependence reduction, and motivation to quit smoking over a 12-week intervention period. Methods: This open-label, exploratory, randomized controlled trial involved 30 participants randomly assigned to the digital therapeutic group (DTG; n=15; mean age 43.1 years; mean number of daily cigarettes: 9.5) or basic treatment group (BTG; n=15; mean age 48.7 years; mean number of daily cigarettes: 9.2). The DTG received the NICO-THERA program, involving VR sessions (relaxation training, craving coping, and refusal skills) and mobile app–based CBT and MET modules for daily therapeutic exercises. The BTG received basic care including video education and printed materials. The primary outcomes were the 7-day point prevalence abstinence (PPA) and 30-day PPA at 8 weeks and 12 weeks. Secondary outcomes included nicotine dependence (Fagerström Test for Nicotine Dependence [FTND]) and motivation to change (Stages of Change Readiness and Treatment Eagerness Scale–Smoking [SOCRATES-S]). Results: There were no significant differences in 7-day and 30-day PPA between the DTG and BTG. However, in within-group analyses, the DTG showed significant improvements in both 7-day and 30-day PPA at week 8 (z=–2.00, P=.046), along with consistent reductions in smoking days and cigarette consumption across all time points. The BTG only significantly decreased cigarette consumption at week 8. Additionally, the DTG exhibited a significant increase in taking steps of motivation at week 12 (U=19.00, P=.048) compared with the BTG. No adverse device effects were reported. Adherence to smoking cessation diaries and medication logs was higher in the DTG (mean 83 of 84 days, 99%; 9 participants) than in the BTG (mean 74 of 84 days, 88%; 12 participants), based on the 12-week average adherence among those who completed the study. Conclusions: The NICO-THERA digital therapeutic program demonstrated preliminary effectiveness at reducing nicotine dependence. Additionally, participants in the DTG group exhibited a progressive improvement in their motivation to quit smoking, as reflected by a significant reduction in ambivalence at week 8 and increase in proactive cessation efforts at week 12. These results suggest that the structured integration of MET and CBT within the NICO-THERA program effectively reinforced psychological readiness for smoking cessation, fostering a sustained commitment to behavioral change. Trial Registration: Clinical Research Information Service, Republic of Korea KCT0009801; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=28285&status=5&seq_group=28285&search_page=M

BACKGROUND Smoking cessation remains a global challenge, with traditional treatments showing limited long-term success due to low adherence and accessibility issues. Digital therapeutics, such as mobile apps and virtual reality (VR)–based interventions, could offer innovative solutions for smoking cessation treatment. NICO-THERA is a digital therapeutic program integrating cognitive behavioral therapy (CBT) and motivational enhancement therapy (MET) to address nicotine dependence. OBJECTIVE This study aims to evaluate the safety and efficacy of NICO-THERA, a digital therapeutic intervention combining VR and mobile apps, for supporting smoking cessation among individuals with nicotine dependence. The primary focus was on smoking abstinence, nicotine dependence reduction, and motivation to quit smoking over a 12-week intervention period. METHODS This open-label, exploratory, randomized controlled trial involved 30 participants randomly assigned to the digital therapeutic group (DTG; n=15; mean age 43.1 years; mean number of daily cigarettes: 9.5) or basic treatment group (BTG; n=15; mean age 48.7 years; mean number of daily cigarettes: 9.2). The DTG received the NICO-THERA program, involving VR sessions (relaxation training, craving coping, and refusal skills) and mobile app–based CBT and MET modules for daily therapeutic exercises. The BTG received basic care including video education and printed materials. The primary outcomes were the 7-day point prevalence abstinence (PPA) and 30-day PPA at 8 weeks and 12 weeks. Secondary outcomes included nicotine dependence (Fagerström Test for Nicotine Dependence [FTND]) and motivation to change (Stages of Change Readiness and Treatment Eagerness Scale–Smoking [SOCRATES-S]). RESULTS There were no significant differences in 7-day and 30-day PPA between the DTG and BTG. However, in within-group analyses, the DTG showed significant improvements in both 7-day and 30-day PPA at week 8 (z=–2.00, P=.046), along with consistent reductions in smoking days and cigarette consumption across all time points. The BTG only significantly decreased cigarette consumption at week 8. Additionally, the DTG exhibited a significant increase in taking steps of motivation at week 12 (U=19.00, P=.048) compared with the BTG. No adverse device effects were reported. Adherence to smoking cessation diaries and medication logs was higher in the DTG (mean 83 of 84 days, 99%; 9 participants) than in the BTG (mean 74 of 84 days, 88%; 12 participants), based on the 12-week average adherence among those who completed the study. CONCLUSIONS The NICO-THERA digital therapeutic program demonstrated preliminary effectiveness at reducing nicotine dependence. Additionally, participants in the DTG group exhibited a progressive improvement in their motivation to quit smoking, as reflected by a significant reduction in ambivalence at week 8 and increase in proactive cessation efforts at week 12. These results suggest that the structured integration of MET and CBT within the NICO-THERA program effectively reinforced psychological readiness for smoking cessation, fostering a sustained commitment to behavioral change. CLINICALTRIAL Clinical Research Information Service, Republic of Korea KCT0009801; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=28285&status=5&seq_group=28285&search_page=M