scholarly journals A randomized controlled trial of a novel smoking cessation smartphone app integrated with a mobile CO checker

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Hiroki Tateno ◽  
Katsunori Masaki ◽  
Akihiro Nomura ◽  
Eisuke Hida ◽  
Koichi Fukunaga
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Controlled Trial ◽  
Smartphone App ◽  
Randomized Controlled

scholarly journals A Novel Smoking Cessation Smartphone App Integrated With a Mobile Carbon Monoxide Checker for Smoking Cessation Treatment: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Akihiro Nomura ◽  
Hiroki Tateno ◽  
Katsunori Masaki ◽  
Tomoyasu Muto ◽  
Shin Suzuki ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Nicotine Dependence ◽  
Controlled Trial ◽  
Smartphone App ◽  
Smoking Cessation Treatment ◽  
Randomized Controlled ◽  
Cessation Treatment ◽  
Co Concentration ◽  
Continuous Abstinence

BACKGROUND Smoking cessation treatment programs have been widely available for patients with nicotine dependence. Despite intensive programs, the continuous abstinence rate (CAR) from weeks 9-12 is still about 50%. Recently, a smartphone app emerged as a novel tool for therapeutic interventions, including nicotine dependence. In this study, we developed “CureApp Smoking Cessation” (CASC), which consists of a smartphone app for patients and a Web-based patient management software for doctors with a mobile carbon monoxide (CO) checking device to improve the efficacy of the smoking cessation treatment. OBJECTIVE This study aims to evaluate whether the CASC app is effective for individuals with nicotine dependence in addition to standard smoking cessation programs. METHODS This will be a randomized, sham-controlled, open-label, multicenter trial. We will recruit participants with nicotine dependence, but are otherwise healthy adults. We will randomize and allocate participants 1:1 to the CASC treatment group or a control app group. Both groups will receive a 12-week standard smoking cessation program with pharmacotherapy and counseling. In addition, participants in the treatment group will have the CASC app installed on their smartphone, which will provide video tutorials, advice from an artificial intelligence nurse, a digital diary, and measure daily exhaled CO concentration. In contrast, the control group will have the control app installed on their smartphone, where all the functions that can potentially effect smoking cessation are removed. The primary outcome will be the biochemically validated CAR from weeks 9-24. The success of smoking cessation will be defined as self-reported continuous abstinence from weeks 9-24 and exhaled CO concentration ≤10 ppm both at weeks 12 and 24. The main secondary outcomes will be the CAR from weeks 9-12, weeks 9-52, and 7-day point prevalence abstinence at weeks 4, 8, 12, 24, and 52. RESULTS We will recruit 580 participants with nicotine dependence from October 2017 to September 2018 or until the recruitment process is complete. The final 52-week follow-up will be completed in October 2019. We expect all trial results to be available by the end of 2019. The trial is funded by CureApp, Inc. CONCLUSIONS This is the first randomized controlled trial to evaluate the efficacy of CASC. We expect that CASC, in addition to standard smoking cessation programs, has a significantly higher CAR during weeks 9-24 than the control app. CLINICALTRIAL University Hospital Medical Information Network Clinical Trials Registry UMIN000031589; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000033555 INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12252

scholarly journals Craving to Quit: A Randomized Controlled Trial of Smartphone App–Based Mindfulness Training for Smoking Cessation

2018 ◽  
Vol 22 (3) ◽  
pp. 324-331 ◽  
Author(s):  
Kathleen A Garrison ◽  
Prasanta Pal ◽  
Stephanie S O’Malley ◽  
Brian P Pittman ◽  
Ralitza Gueorguieva ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Controlled Trial ◽  
Experience Sampling ◽  
Positive Association ◽  
Preliminary Evidence ◽  
Mindfulness Training ◽  
Smartphone App ◽  
Randomized Controlled ◽  
Intent To Treat

Abstract Introduction Mindfulness training may reduce smoking rates and lessen the association between craving and smoking. This trial tested the efficacy of mindfulness training via smartphone app to reduce smoking. Experience sampling (ES) was used to measure real-time craving, smoking, and mindfulness. Methods A researcher-blind, parallel randomized controlled trial compared the efficacy of mobile mindfulness training with experience sampling (MMT-ES; Craving to Quit) versus experience sampling only (ES) to (1) increase 1-week point-prevalence abstinence rates at 6 months, and (2) lessen the association between craving and smoking. A modified intent-to-treat approach was used for treatment starters (MMT-ES n = 143; ES n = 182; 72% female, 81% white, age 41 ± 12 year). Results No group difference was found in smoking abstinence at 6 months (overall, 11.1%; MMT-ES, 9.8%; ES, 12.1%; χ2(1) = 0.43, p = .51). From baseline to 6 months, both groups showed a reduction in cigarettes per day (p < .0001), craving strength (p < .0001) and frequency (p < .0001), and an increase in mindfulness (p < .05). Using ES data, a craving by group interaction was observed (F(1,3785) = 3.71, p = .05) driven by a stronger positive association between craving and cigarettes per day for ES (t = 4.96, p < .0001) versus MMT-ES (t = 2.03, p = .04). Within MMT-ES, the relationship between craving and cigarettes per day decreased as treatment completion increased (F(1,104) = 4.44, p = .04). Conclusions Although mindfulness training via smartphone app did not lead to reduced smoking rates compared with control, our findings provide preliminary evidence that mindfulness training via smartphone app may help lessen the association between craving and smoking, an effect that may be meaningful to support quitting in the longer term. Implications This is the first reported full-scale randomized controlled trial of any smartphone app for smoking cessation. Findings provide preliminary evidence that smartphone app-based MMT-ES may lessen the association between craving and smoking. Trial registration Clinicaltrials.gov NCT02134509.

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