Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Dec 21, 2019
Date Accepted: Jun 3, 2020
Virtual reality smartphone-based smoking cessation: A pilot RCT on initial clinical efficacy and adherence
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 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 influence over long-term outcomes. Clinical Trial: isrctn.com ID ISRCTN50586181, http://www.isrctn.com/ISRCTN50586181
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