Pilot Study of a Mobile, Virtual Reality-Based Digital Therapeutic for Smoking Cessation: Randomized Controlled Trial

Area of Science:

• Digital health interventions
• Behavioral medicine
• Addiction treatment

Background:

• Traditional smoking cessation methods face challenges in long-term success due to adherence and accessibility issues.
• Digital therapeutics, including mobile apps and virtual reality (VR), offer potential solutions for smoking cessation.
• NICO-THERA is a digital therapeutic integrating cognitive behavioral therapy (CBT) and motivational enhancement therapy (MET) for nicotine dependence.

Purpose of the Study:

• To evaluate the safety and efficacy of the NICO-THERA digital therapeutic intervention for smoking cessation.
• To assess smoking abstinence, nicotine dependence reduction, and motivation to quit over a 12-week period.
• To investigate the combined use of VR and mobile apps in smoking cessation.

Main Methods:

• An open-label, exploratory, randomized controlled trial with 30 participants.
• Participants were assigned to either the digital therapeutic group (DTG) or basic treatment group (BTG).
• The DTG used NICO-THERA (VR sessions and mobile CBT/MET modules), while the BTG received standard care.

Main Results:

• The DTG showed significant within-group improvements in 7-day and 30-day point prevalence abstinence (PPA) at week 8.
• The DTG demonstrated consistent reductions in smoking days and cigarette consumption, and increased motivation to quit by week 12.
• No adverse events were reported, and adherence was higher in the DTG.

Conclusions:

• NICO-THERA shows preliminary effectiveness in reducing nicotine dependence and enhancing motivation to quit.
• The integration of MET and CBT within NICO-THERA supports psychological readiness for smoking cessation.
• Digital therapeutics like NICO-THERA offer a promising avenue for sustained behavioral change in smoking cessation.