Goldenhersch Emilio, Thrul Johannes, Ungaretti Joaquín, Rosencovich Nicolas, Waitman Cristian, Ceberio Marcelo Rodriguez
Laboratorio de Investigación en Neurociencia y Ciencias Sociales, Universidad de Flores, Ciudad Autónoma de Buenos Aires, Argentina.
Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.
J Med Internet Res. 2020 Jul 29;22(7):e17571. doi: 10.2196/17571.
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.
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.
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.
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 (χ=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.
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.
ISRCTN Registry ISRCTN50586181; http://www.isrctn.com/ISRCTN50586181.
当前戒烟项目面临的障碍包括有效干预措施的获取受限和依从性不佳。数字干预为克服这些困难提供了绝佳机会，但虚拟现实尚未被用作一种远程且可自我管理的工具来提高数字戒烟干预措施的依从性和有效性。
本研究旨在通过一项初步随机对照试验，评估数字干预措施Mindcotine（MindCotine公司）采用虚拟现实与正念相结合的自我管理治疗方法时参与者的依从性和戒烟效果。
在阿根廷布宜诺斯艾利斯市招募了120名参与者（平均年龄43.20岁，标准差9.50；57/120，47.5%为女性）。参与者被随机分配到治疗组（TG），该组接受基于虚拟现实正念暴露疗法（VR-MET）课程、每日调查以及由心理学家主持的在线同伴支持的21天自我辅助项目；或对照组（CG），该组接受阿根廷卫生部戒烟手册的在线版本。干预后及90天随访时通过在线调查进行随访评估。主要结局是干预后自我报告的戒烟情况，缺失数据视为仍在吸烟。次要结局包括90天随访时的持续戒烟情况、项目依从性以及戒烟意愿。
第1天的随访率治疗组为93%（56/60），对照组为100%（60/60）。干预后，治疗组当天报告的戒烟率为23%（14/60），而对照组为5%（3/60）。这一差异具有统计学意义（χ=8.3；P=.004）。治疗组报告90天时持续戒烟率为33%（20/60）。由于对照组中只有20%（12/60）的参与者完成了90天随访，因此在这个随访时间点我们未对两组进行统计学比较。在干预后仍在吸烟的参与者中，治疗组相比对照组戒烟意愿明显更强（治疗组：均值7.71，标准差0.13；对照组：均值7.16，标准差0.13；P=.005）。共有41%（23/56）的参与者在项目推荐的时间框架内完成了治疗。
研究结果为参与者对Mindcotine的依从性和疗效提供了初步支持，有必要在一项充分有力的随机试验中对该干预措施进行测试。然而，对照组参与者试验随访评估程序的可行性需要改进。关于VR-MET对长期结局的影响还需要进一步研究。
ISRCTN注册库ISRCTN50586181；http://www.isrctn.com/ISRCTN50586181 。
