Pilot Study of a Mobile and Virtual Reality-Based Digital Therapeutics for Smoking Cessation: A Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND Smoking cessation remains a global challenge with existing treatments showing limited long-term success. Digital therapeutics, such as app- and virtual reality (VR)-based interventions, have the potential to offer more personalized and accessible solutions. This study investigates the efficacy of combined digital therapeutic intervention for smoking cessation. OBJECTIVE This study aims to evaluate the safety and efficacy of NICO-THERA, a digital therapeutic intervention combining VR and mobile applications, in supporting smoking cessation among individuals with nicotine dependence. Specifically, the study examines the impact of this intervention on smoking abstinence and nicotine dependence over a 12-week treatment period. METHODS We conducted an open-label, randomized, controlled exploratory trial involving 30 participants who were randomly assigned to either the Digital Therapeutic Group (DTG) or the Basic Treatment Group (BTG). The DTG received the NICO-THERA program, which included VR-based relaxation, craving coping, and refusal training sessions along with additional therapy through a mobile application, all grounded in cognitive behavioral therapy (CBT) and motivational enhancement therapy (MET). The BTG received standard care including video education, printed materials. The primary outcomes measured were the 7-day point prevalence abstinence (PPA) and 30-day PPA at 8 and 12 weeks. Secondary outcomes included nicotine dependence and the motivation to change. RESULTS The participants in the DTG demonstrated significantly higher smoking abstinence rates than those in the BTG. At 12 weeks, the 7-day PPA was 55.6% in the DTG and 41.7% in the BTG, whereas the 30-day PPA was 55.6% and 33.3%, respectively. Additionally, the DTG showed a reduction in nicotine dependence scores and an increase in the motivation to quit smoking. The VR intervention was well-tolerated, with no significant adverse events reported. CONCLUSIONS The NICO-THERA digital therapeutic program appears to be a safe and effective intervention for smoking cessation. The integration of VR and mobile applications into a structured therapeutic approach offers a promising complement to traditional smoking cessation treatments, potentially improving long-term abstinence rates and reducing nicotine dependence. 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