JMIR Publications

ABSTRACT

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 applications and virtual reality (VR)-based interventions, could offer innovative solutions in the 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 applications, in 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:

We conducted an open-label, randomized, controlled exploratory trial involving 30 participants who were randomly assigned to either the Digital Therapeutic Group (DTG, n=15; mean age: 43.1; daily cigarettes: 9.5) or the Basic Treatment Group (BTG, n=15; mean age: 48.7; daily cigarettes: 9.2). The DTG received the NICO-THERA program, which included VR sessions (relaxation training, craving coping, and refusal skills) and mobile application-based CBT and MET modules for daily therapeutic exercises. The BTG received basic 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 (FTND) and the motivation to change (SOCRATES-S).

Results:

There were no significant differences in 7-day and 30-day PPA between the DTG and BTG. However, at 12 weeks, the PPA difference was 14% for the 7-day rate (DTG 56%, BTG 42%) and 22.3% for the 30-day rate (DTG 56%, BTG 33%), with the DTG showing a higher success rate. Additionally, the DTG showed a significant reduction in nicotine dependence from baseline to 8 weeks (U=26.00, P=.03), which was maintained at 12 weeks (U=31.00, P=.05). In terms of motivation, the DTG showed a significant decrease in ambivalence at week 8 (U=23.50, P=.03) and an increase in taking steps at week 12 (U=28.50, P=.07), compared to the BTG. No adverse device effects were reported for NICO-THERA, and adherence to smoking cessation diaries and medication logs was higher in the DTG (99%) than in the BTG (88%).

Conclusions:

The NICO-THERA digital therapeutic program has demonstrated effectiveness in 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 an 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. Clinical Trial: 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