Background Obstacles to current tobacco cessation programs include limited access and adherence to effective interventions. Digital interventions offer a great opportunity to overcome these difficulties, yet virtual reality has not been used as a remote and self-administered tool to help increase adherence and effectiveness of digital interventions for tobacco cessation. Objective This study aimed to evaluate participant adherence and smoking cessation outcomes in a pilot randomized controlled trial of the digital intervention Mindcotine (MindCotine Inc) using a self-administered treatment of virtual reality combined with mindfulness. Methods A sample of 120 participants was recruited in the city of Buenos Aires, Argentina (mean age 43.20 years, SD 9.50; 57/120, 47.5% female). Participants were randomly assigned to a treatment group (TG), which received a self-assisted 21-day program based on virtual reality mindful exposure therapy (VR-MET) sessions, daily surveys, and online peer-to-peer support moderated by psychologists, or a control group (CG), which received the online version of the smoking cessation manual from the Argentine Ministry of Health. Follow-up assessments were conducted by online surveys at postintervention and 90-day follow-up. The primary outcome was self-reported abstinence at postintervention, with missing data assumed as still smoking. Secondary outcomes included sustained abstinence at 90-day follow-up, adherence to the program, and readiness to quit. Results Follow-up rates at day 1 were 93% (56/60) for the TG and 100% (60/60) for the CG. At postintervention, the TG reported 23% (14/60) abstinence on that day compared with 5% (3/60) in the CG. This difference was statistically significant (χ21=8.3; P=.004). The TG reported sustained abstinence of 33% (20/60) at 90 days. Since only 20% (12/60) of participants in the CG completed the 90-day follow-up, we did not conduct a statistical comparison between groups at this follow-up time point. Among participants still smoking at postintervention, the TG was significantly more ready to quit compared to the CG (TG: mean 7.71, SD 0.13; CG: mean 7.16, SD 0.13; P=.005). A total of 41% (23/56) of participants completed the treatment in the time frame recommended by the program. Conclusions Results provide initial support for participant adherence to and efficacy of Mindcotine and warrant testing the intervention in a fully powered randomized trial. However, feasibility of trial follow-up assessment procedures for control group participants needs to be improved. Further research is needed on the impact of VR-MET on long-term outcomes. Trial Registration ISRCTN Registry ISRCTN50586181; http://www.isrctn.com/ISRCTN50586181

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BACKGROUND Obstacles to current tobacco cessation programs include limited access and adherence to effective interventions. Digital interventions offer a great opportunity to overcome these difficulties, yet virtual reality has not been used as a remote and self-administered tool to help increase adherence and effectiveness for tobacco cessation. OBJECTIVE This study aimed to evaluate participant adherence and smoking cessation outcomes in a randomized pilot trial of the digital intervention Mindcotine® utilizing a self-administered treatment using virtual reality combined with mindfulness. METHODS A sample of 120 participants was recruited in the City of Buenos Aires, Argentina (age M = 43.20 years, SD = 9.50; 57/120 (47.5%) female). Participants were randomly assigned to a treatment group (TG), which received a self-assisted 21-day program based on Virtual Reality Mindful Exposure Therapy (VR-MET) sessions, daily surveys, and online peer-to-peer support moderated by psychologists; and a control group (CG), which received the online version of the smoking cessation manual from the Argentine Ministry of Health. Follow-up assessments were conducted by online survey at post-intervention and 90-day follow-up. The primary outcome was self-reported abstinence at post-intervention, with missing data assumed as still smoking. Secondary outcomes included sustained abstinence at 90-day follow-up, adherence to the program, and readiness to quit. RESULTS Follow-up rates at day-1 were 93% (56/60) for the TG and 100% (60/60) for the CG. At post-intervention, the TG reported 23.3% (14/60) abstinence on that day compared to 5.0% (3/60) in the CG. This difference was statistically significant (Chi2 (1) =8.3; P = .004). The TG reported sustained abstinence of 33% (20/60) at 90 days. Since only 20% (12/60) participants in the CG completed the 90-day follow-up, we did not conduct a statistical comparison between groups at this follow-up time-point. Among participants still smoking at post-intervention, the TG was significantly more ready to quit compared to the CG (TG: M = 7.71; SD = 0.13; CG: M = 7.16; SD = 0.13; P = 0.005). A total of 41.1% (23/56) of participants completed the treatment in the time frame recommended by the program. CONCLUSIONS Results provide initial support for participant adherence and efficacy of Mindcotine® and warrant testing the intervention in a fully powered randomized trial. However, feasibility of trial follow-up assessment procedures for control participants needs to be improved. Further research is needed on the VR-MET impact on long-term outcomes. CLINICALTRIAL isrctn.com ID ISRCTN50586181, http://www.isrctn.com/ISRCTN50586181