None listed
Conditions
Interventions
Medical Device : Digital Therapeutic Group (DTG): The NICO-THERA program is designed as a combination of virtual reality (VR) and a smartphone application for a 12-week treatment period. The VR compon
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) adults aged between 19 and under 75 years 2) individuals diagnosed with nicotine addiction according to the clinical criteria for mental and behavioral disorders due to use of tobacco (F17) or toxic effect of tobacco and nicotine (T652) as per the Korean Classification of Diseases (KCD), and in accordance with the clinical criteria for nicotine use disorders specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) 3) individuals who smoked an average of five or more cigarettes per day in the past six months 4) participants who were able to communicate with the researcher and consented to the procedures required by the study protocol, understanding the objectives of the research and signing the consent form 5) smartphone users who agreed to install and use an application for data collection and management 6) smartphone users who agreed to receive text messages and respond to survey items via their smartphones, consenting to data collection and management.
Exclusion criteria
Exclusion criteria: 1) individuals assessed not to meet the clinical criteria for mental and behavioral disorders due to use of tobacco (F17) or toxic effect of tobacco and nicotine (T652) according to the KCD, based on individual interviews with a specialist or researcher 2) individuals with cognitive impairments affecting decision-making capacity 3) those unable to participate in the programs specified in the study protocol 4) those who had started or were undergoing another cognitive behavioral therapy within the last three months 5) (for the digital therapeutics group) individuals who either did not own a smartphone registered in their name or lacked significant ability to use smartphones including app utilization 6) individuals without a smartphone or significantly limited ability to use smartphones including receiving text messages 7) those at severe risk of depression, suicidal ideation, or suicide attempts 8) other reasons deemed by the investigator as inappropriate for participation in the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 7-day point prevalence abstinence ;30-day point prevalence abstinence | — |
Secondary
| Measure | Time frame |
|---|---|
| Stages of Change Readiness and Treatment Eagerness Scale-Smoking (SOCRATES-S);Fagerström Test for Nicotine Dependence (FTND) Score;Simulator Sickness Questionnaire (SSQ);PHQ-9(Patient Health Questionnaire);GAD-7(The 7-item Generalized Anxiety Disorder Scale);7-day /30-day point prevalence abstinence | — |
Countries
Korea, Republic of
Contacts
Public ContactArom Pyeon
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed