%0 Journal Article
%@ 1438-8871
%I JMIR Publications
%V 22
%N 7
%P e17571
%T Virtual Reality Smartphone-Based Intervention for Smoking Cessation: Pilot Randomized Controlled Trial on Initial Clinical Efficacy and Adherence
%A Goldenhersch,Emilio
%A Thrul,Johannes
%A Ungaretti,Joaquín
%A Rosencovich,Nicolas
%A Waitman,Cristian
%A Ceberio,Marcelo Rodriguez
%+ Laboratorio de Investigación en Neurociencia y Ciencias Sociales, Universidad de Flores, Avenida Rivadavia 5741, Ciudad Autónoma de Buenos Aires, CP 1414, Argentina, 1 4808860102, emiliogolden@gmail.com
%K smoking cessation
%K nicotine dependence
%K craving
%K virtual reality
%K mindfulness
%K digital therapy
%K mHealth
%K mobile phone
%D 2020
%7 29.7.2020
%9 Original Paper
%J J Med Internet Res
%G English
%X 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 
%M 32723722
%R 10.2196/17571
%U http://www.jmir.org/2020/7/e17571/
%U https://doi.org/10.2196/17571
%U http://www.ncbi.nlm.nih.gov/pubmed/32723722