@Article{info:doi/10.2196/17571,
author="Goldenhersch, Emilio
and Thrul, Johannes
and Ungaretti, Joaqu{\'i}n
and Rosencovich, Nicolas
and Waitman, Cristian
and Ceberio, Marcelo Rodriguez",
title="Virtual Reality Smartphone-Based Intervention for Smoking Cessation: Pilot Randomized Controlled Trial on Initial Clinical Efficacy and Adherence",
journal="J Med Internet Res",
year="2020",
month="Jul",
day="29",
volume="22",
number="7",
pages="e17571",
keywords="smoking cessation; nicotine dependence; craving; virtual reality; mindfulness; digital therapy; mHealth; mobile phone",
abstract="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 ($\chi$21=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 ",
issn="1438-8871",
doi="10.2196/17571",
url="http://www.jmir.org/2020/7/e17571/",
url="https://doi.org/10.2196/17571",
url="http://www.ncbi.nlm.nih.gov/pubmed/32723722"
}