Dataset Information

Efficacy of cognitive behavioural therapy-based smartphone app for smoking cessation in China: a study protocol of a randomised controlled trial.

ABSTRACT:

Introduction

A number of smartphone apps have been proved to be effective in assisting smoking cessation in many countries, but little is known about the effectiveness of smartphone apps that assist in smoking cessation in China. This study aims to evaluate the efficacy of cognitive behavioural therapy (CBT)-based cigarette smoking cessation smartphone app for treatment-seeking smokers in China.

Methods and analysis

In this remote control, randomised controlled trial, the participants will be randomised and allocated in 1:1 ratio to smoking cessation app intervention group or to control group. Participants will receive a 12-week intervention (treatment group will receive CBT-based cigarette smoking cessation smartphone app intervention and control group will receive text messaging-based control intervention) with follow-up at week 26. The primary outcome includes biologically verified continuous smoking abstinence at week 26 after the quit date. The main secondary outcomes include 7-hour point prevalence smoking abstinence at weeks 1, 2, 3, 4, 8, 12, 16, 20 and 26, self-reported continuous smoking abstinence at weeks 4, 8, 12, 16, 20 and 26 after the quit date. About 1200 smokers with willingness to make a quit attempt within a month from January 2021 to August 2021 or until the recruitment process is complete will be recruited. The final 26-week follow-up will be completed in August 2022. The trial results will be available by the end of 2022. All analyses will be done on an intention-to-treat basis. Based on the previous studies, we hypothesised that this CBT-based app will be an effective, feasible and accessible smoking cessation app in China.

Ethics and dissemination

Ethical approval was obtained from the ethics committee of Sir Run Run Shaw Hospital, an affiliate of Zhejiang University, Medical College (number: 20200129-33). Study results will be disseminated via research conference presentations and peer-reviewed publications.

Trial registration number

NCT04421170.

SUBMITTER: Liao Y

PROVIDER: S-EPMC7812100 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy of cognitive behavioural therapy-based smartphone app for smoking cessation in China: a study protocol of a randomised controlled trial.

Liao Yanhui Y Tang Jinsong J

BMJ open 20210113 1

<h4>Introduction</h4>A number of smartphone apps have been proved to be effective in assisting smoking cessation in many countries, but little is known about the effectiveness of smartphone apps that assist in smoking cessation in China. This study aims to evaluate the efficacy of cognitive behavioural therapy (CBT)-based cigarette smoking cessation smartphone app for treatment-seeking smokers in China.<h4>Methods and analysis</h4>In this remote control, randomised controlled trial, the particip ...[more]

PMID: 33441359

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Project description:BackgroundPrevious research has suggested that mobile phone applications (apps) may potentially increase quit rates. The purpose of this single-group cohort study sought to examine the feasibility and acceptability of a novel smartphone-based smoking cessation app designed for smoking cessation in China: smoking quit rate.MethodsA total of 180 smokers from two cities of mainland China with willingness to make a quit attempt were invited to this smoking cessation app program, a cognitive behavioral theory (CBT)-based smoking cessation intervention via a smartphone app. Participants received 37- to 44-day intervention (including 7- to 14-day pre-quit preparation and 33-day intervention from quit date). Feasibility and acceptability of the program, and smoking status were assessed at baseline stage (initial installation), pre-quit stage, and post-quit stage (days 7, 15, and 33 after quit date).ResultsA total of 163 (90.6%) participants completed the study. Among them, 76-89% of the participants logged into the app ≥1 time per day across stages (at baseline, during pre-quit stage, and on days 7, 15, and 33 of post-quit stage); approximately 90% of the participants were satisfied with the app across stages. A significant rise in self-reported overall satisfaction with the app is observed from baseline (93% at Time 1) to the end of the program (98% at Time 2, 33 days after quit date) (p = 0.021). Participants who believed/agreed this app can help them to quit smoking significantly increased from 69% at baseline to 97% at day 33 after quit date (p < 0.001). Participants were satisfied with most (80-90%) of the features, especially the information feature. Intention-to-treat analysis showed that the percentage of 33-day self-reported continuous prevalence abstinence was 63.9%, and 7-day point prevalence abstinence rate was 81.7, 87.2, and 77.8% on days 7, 15, and 33 after quit date, respectively.ConclusionsThis study demonstrated the feasibility and acceptability of the smartphone app intervention for smoking cessation and introduced a new digital treatment model, which is expected to overcome barriers facing accessing traditional in-person smoking cessation services and extend nationwide smoking cessation services in China.

Project description:BackgroundTobacco smoking is the leading cause of preventable death in the United States, and the annual economic burden attributable to smoking exceeds US $300 billion. Obstacles to smoking cessation include limited access and adherence to effective cessation interventions. Technology can help overcome these obstacles; many smartphone apps have been developed to aid smoking cessation, but few that conform to the US clinical practice guideline (USCPG) have been rigorously tested and reported in the literature. Clickotine is a novel smartphone app for smoking cessation, designed to deliver the essential features of the USCPG and engineered to engage smokers by personalizing intervention components.ObjectiveOur objective was to assess the engagement, efficacy, and safety of Clickotine in an initial, single-arm study. Outcomes measured were indicators of engagement with the smartphone app (number of app opens, number of interactions with the Clickotine program, and weeks active with Clickotine), cessation outcomes of 7- and 30-day self-reported abstinence from smoking, and negative health events.MethodsWe recruited US residents between 18 and 65 years of age who owned an iPhone and smoked 5 or more cigarettes daily for the study via online advertising. Respondents were prescreened for eligibility by telephone and, if appropriate, directed to a Web portal to provide informed consent, confirm eligibility, and download the Clickotine app. Participants completed study assessments via the online portal at baseline and after 8 weeks. Data were collected in Amazon S3 with no manual data entry, and access to all data was maximally restrictive, logged, and auditable.ResultsA total of 416 participants downloaded the app and constituted the intention-to-treat (ITT) sample. On average, participants opened the Clickotine app 100.6 times during the 8-week study (median 69), logged 214.4 interactions with the Clickotine program (median 178), and remained engaged with Clickotine for 5.3 weeks (median 5). Among the ITT sample, 45.2% (188/416) reported 7-day abstinence and 26.2% (109/416) reported 30-day abstinence from smoking after 8 weeks. Completer analysis focused on 365 (87.7%) of the 416 enrolled participants who completed the 8-week questionnaire revealed that 51.5% (188/365) of completers reported 7-day abstinence and 29.9% (109/365) reported 30-day abstinence. Few adverse events, mostly consistent with nicotine withdrawal symptoms, were reported and overall no safety signal was detected.ConclusionsIn this initial single-arm trial, Clickotine users appeared to demonstrate encouraging indicators of engagement in terms of the number of app opens, number of program interactions, and continued engagement over time. Clickotine users reported encouraging quit rates while reporting few adverse events. Future research is warranted to assess Clickotine's efficacy in a randomized controlled trial.Trial registrationClinicaltrials.gov NCT02656745; https://clinicaltrials.gov/ct2/show/NCT02656745 (Archived by WebCite at http://www.webcitation.org/6peTT4x60).

Project description:Emerging evidence supports the use of smartphone apps for smoking cessation, especially in young adults given their high smoking rates and high smartphone ownership rates. Although evaluative evidence is encouraging for supporting smoking cessation, there remains a paucity of research describing the design and development processes of mobile health (mHealth) interventions.The aim of this paper was to describe the process of developing Crush the Crave (CTC), an evidence-informed app to support smoking cessation in young adults, and the results of a formative evaluation of app usage behavior, as part of a broader program of research that seeks to establish the effectiveness of the CTC app.The Spiral Technology Action Research (STAR) 5-cycle model (listen, plan, do, act, and study) was employed to guide the development, implementation, and dissemination of CTC. The approach to development and formative evaluation included focus groups with young adult smokers (n=78) across 2 phases, analysis of the content of existing apps, 2 sessions with content experts, and Google Analytics to assess user behavior during a 12-month pilot.LISTEN-focus groups revealed young adult smoker preferences of (1) positive reinforcement, (2) personalization, (3) social support, (4) quit support, (5) tracking the behavior, and (6) tracking quit benefits. PLAN-informed by evidence for smoking cessation, young adult preferences and an assessment of popular cessation apps, content experts produced a mind map and a storyboard describing app content and structure. DO-focus groups with young adult smokers provided feedback on the first version of the app with opinions on content and suggestions for improvement such as providing alerts and distractions from craving. ACT-refinements were made, and app content was organized using the 4 key design components informed by principles of persuasive technology for behavior change: credibility, task support, dialogue support, and social support. CTC was launched in April 2013 and piloted from the period July 2013 to June 2014 where 1987 Android users had 18,567 sessions, resulting in 59,384 page views and 89.58% (1780/1987) of users returning within the same day to use CTC. STUDY-a pragmatic randomized controlled trial of CTC was launched in August 2014 to demonstrate that including mHealth technology as a population-based intervention can help young adult smokers to quit. The results of this phase will be presented in a subsequent publication.CTC is one of the first smoking cessation apps designed to meet the needs of young adult smokers. The development was informed by the inclusion of young adults in the design and the systematic application of multiple stakeholder input, scientific evidence, and theory. The STAR model approach was followed from the beginning of intervention development, which should facilitate optimization of mHealth interventions in the future.ClinicalTrials.gov NCT01983150; http://clinicaltrials.gov/ct2/show/NCT01983150 (Archived by WebCite at http://www.webcitation.org/6VGyc0W0i).

Project description:BACKGROUND:Smoking rates of Australians with severe mental illness (SMI) are disproportionately higher than the general population. Despite the rapid growth in mobile health (mHealth) apps, limited evidence exists to inform their design for SMI populations. OBJECTIVE:This study aimed to explore the feasibility, acceptability, and utility of adapting a novel smoking cessation app (Kick.it) to assist smokers with SMI to prevent smoking relapse and quit. METHODS:Using co-design, two in-depth interviews with 12 adult smokers and ex-smokers with SMI were conducted in this qualitative study. Stage 1 interviews explored participants' smoking-related experiences and perceptions of social support for smoking cessation, informed the development of the stage 2 interview schedule, and provided context for participants' responses to the second interview. Stage 2 interviews explored participants' perceptions of the feasibility, utility, and acceptability of the app features for SMI populations. RESULTS:People with SMI perceived mHealth interventions to support their quit smoking attempts as feasible, acceptable, and useful. Key emerging themes included personalization of the app to users' psychosocial needs, a caring app to mediate self-esteem and self-efficacy, an app that normalizes smoking relapse and multiple quit attempts, a strong focus on user experience to improve usability, and a social network to enhance social support for smoking cessation. CONCLUSIONS:This study gained an in-depth understanding of the lived experiences of smoking and quitting among people with SMI and their perception of the Kick.it app features to help inform the tailoring of the app. Specific program tailoring is required to assist them in navigating the complex interactions between mental illness and smoking in relation to their psychosocial well-being and capacity to quit. This study describes the adaptations required for the Kick.it app to meet the specific needs and preferences of people with SMI. Results of this study will guide the tailoring of the Kick.it app for SMI populations. The study findings can also inform a co-design process for the future development and design of smoking cessation apps for SMI populations.

Project description:ImportanceSmoking is a leading cause of premature death globally. Smartphone applications for smoking cessation are ubiquitous and address barriers to accessing traditional treatments, yet there is limited evidence for their efficacy.ObjectiveTo determine the efficacy of a smartphone application for smoking cessation based on acceptance and commitment therapy (ACT) vs a National Cancer Institute smoking cessation application based on US clinical practice guidelines (USCPG).Design, setting, and participantsA 2-group, stratified, double-blind, individually randomized clinical trial was conducted from May 27, 2017, to September 28, 2018, among 2415 adult cigarette smokers (n = 1214 for the ACT-based smoking cessation application group and n = 1201 for the USCPG-based smoking cessation application group) with 3-, 6-, and 12-month postrandomization follow-up. The study was prespecified in the trial protocol. Follow-up data collection started on August 26, 2017, and ended at the last randomized participant's 12-month follow-up survey on December 23, 2019. Data were analyzed from February 25 to April 3, 2020. The primary analysis was performed on a complete-case basis, with intent-to-treat missing as smoking and multiple imputation sensitivity analyses.InterventionsiCanQuit, an ACT-based smoking cessation application, which taught acceptance of smoking triggers, and the National Cancer Institute QuitGuide, a USCPG-based smoking cessation application, which taught avoidance of smoking triggers.Main outcomes and measuresThe primary outcome was self-reported 30-day point prevalence abstinence (PPA) at 12 months after randomization. Secondary outcomes were 7-day PPA at 12 months after randomization, prolonged abstinence, 30-day and 7-day PPA at 3 and 6 months after randomization, missing data imputed with multiple imputation or coded as smoking, and cessation of all tobacco products (including e-cigarettes) at 12 months after randomization.ResultsParticipants were 2415 adult cigarette smokers (1700 women [70.4%]; 1666 White individuals [69.0%] and 868 racial/ethnic minorities [35.9%]; mean [SD] age at enrollment, 38.2 [10.9] years) from all 50 US states. The 3-month follow-up data retention rate was 86.7% (2093), the 6-month retention rate was 88.4% (2136), and the 12-month retention rate was 87.2% (2107). For the primary outcome of 30-day PPA at the 12-month follow-up, iCanQuit participants had 1.49 times higher odds of quitting smoking compared with QuitGuide participants (28.2% [293 of 1040] vs 21.1% [225 of 1067]; odds ratio [OR], 1.49; 95% CI, 1.22-1.83; P < .001). Effect sizes were very similar and statistically significant for 7-day PPA at the 12-month follow-up (OR, 1.35; 95% CI, 1.12-1.63; P = .002), prolonged abstinence at the 12-month follow-up (OR, 2.00; 95% CI, 1.45-2.76; P < .001), abstinence from all tobacco products (including e-cigarettes) at the 12-month follow-up (OR, 1.60; 95% CI, 1.28-1.99; P < .001), 30-day PPA at 3-month follow-up (OR, 2.20; 95% CI, 1.68-2.89; P < .001), 30-day PPA at 6-month follow-up (OR, 2.03; 95% CI, 1.63-2.54; P < .001), 7-day PPA at 3-month follow-up (OR, 2.04; 95% CI, 1.64-2.54; P < .001), and 7-day PPA at 6-month follow-up (OR, 1.73; 95% CI, 1.42-2.10; P < .001).Conclusions and relevanceThis trial provides evidence that, compared with a USCPG-based smartphone application, an ACT-based smartphone application was more efficacious for quitting cigarette smoking and thus can be an impactful treatment option.Trial registrationClinicalTrials.gov Identifier: NCT02724462.

Dataset Information

Efficacy of cognitive behavioural therapy-based smartphone app for smoking cessation in China: a study protocol of a randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Efficacy of cognitive behavioural therapy-based smartphone app for smoking cessation in China: a study protocol of a randomised controlled trial.

Similar Datasets

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