Assessing the effect of an interactive decision-aid smartphone smoking cessation application (app) on quit rates: a double-blind automated randomised control trial protocol.
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ABSTRACT: Introduction
In a previous study exploring the feasibility of a smoking cessation application (app), we found that about 77% of the respondents from three countries were ready to quit in the next 30?days without significant differences between countries in terms of age, operating system and number of quitting attempts. However, the efficacy of smartphone apps for smoking cessation has not yet been established. This study tests the efficacy of a smartphone smoking cessation decision-aid app compared with an app that contains only smoking cessation information.Methods and analysis
This is an automated double-blind, randomised controlled trial of a smoking cessation app that contains the eligibility requirements and baseline questionnaire and will randomise the participants into one of the two subapps (the intervention and the control). Participants will be recruited directly from the Apple app stores in Australia, Singapore, the UK and the USA. Daily smokers aged 18 and above will be randomised into one of the subapps after completing the baseline questionnaire. Abstinence rates will be measured at 10?days, 1?month, 3?months and 6?months, with the 1-month follow-up abstinence rate as the primary outcome. Logistic regression mixed models will be used to analyse the primary outcome.Ethics and dissemination
This study was approved by the University of Sydney's Human Ethics Committee. The results of the trial will be published in peer-reviewed journals according to the CONSORT statement.Trial registration number
Australian New Zealand ClinicalTrial RegistryACTRN12613000833763.
SUBMITTER: BinDhim NF
PROVIDER: S-EPMC4120407 | biostudies-literature | 2014 Jul
REPOSITORIES: biostudies-literature
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Project description:OBJECTIVE:To assess the efficacy of an interactive smoking cessation decision-aid application (pp) compared with a smoking cessation static information app on continuous abstinence. DESIGN:Automated double-blind randomised controlled trial with 6 months follow-up (2014-2015). SETTING:Smartphone-based. PARTICIPANTS:684 participants (daily smokers of cigarettes, 18 years old or over) recruited passively from app stores in the USA, Australia, UK and Singapore, and randomised to one of two sub-apps. INTERVENTIONS:Behavioural, decision-aid, smartphone application. MAIN OUTCOMES:Continuous abstinence at 10 days, 1 month, 3 months and 6 months. RESULTS:Smokers who received the decision-aid app were more likely to be continuously abstinent at 1 month compared with the information-only app (28.5% vs 16.9%; relative risk (RR) 1.68; 95% CI 1.25 to 2.28). The effect was sustained at 3 months (23.8% vs 10.2%; RR 2.08; 95% CI 1.38 to 3.18) and 6 months (10.2% vs 4.8%; RR 2.02; 95% CI 1.08 to 3.81). Participants receiving the decision-aid app were also more likely to have made an informed choice (31.9% vs 19.6%) and have lower decisional conflict (19.5% vs 3.9%). CONCLUSION:A smartphone decision-aid app with support features significantly increased smoking cessation and informed choice. With an increasing number of smokers attempting to quit, unassisted evidence-based decision-aid apps can provide an effective and user-friendly option to many who are making quit decisions without healthcare professionals. TRIAL REGISTRATION NUMBER:ACTRN12613000833763.
| S-EPMC5780681 | biostudies-literature
Project description:IntroductionMindfulness 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.MethodsA 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).ResultsNo 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).ConclusionsAlthough 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.ImplicationsThis 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 registrationClinicaltrials.gov NCT02134509.
| S-EPMC7297096 | biostudies-literature
Project description:ObjectivesThe use of mobile technology for smoking cessation holds promise for adolescents, who do not typically access traditional treatments, but most are not grounded in theory or mechanism. Operant conditioning theory suggests an addictive smoking loop is formed between nicotine use and affective states, leading to habitual cue-induced craving and automatic behavior; mindfulness training may bring automated smoking behavior into awareness, so smokers may work mindfully with cravings. Mindfulness training delivered via smartphone technology therefore has potential to help adolescent smokers break this addictive loop and quit smoking. This pair-matched cluster-randomized controlled school-based pilot study evaluated program feasibility and preliminary smoking outcomes in relation to intervention engagement.MethodsSix high schools were pair matched and randomly assigned to one of three interventions: (1) mindfulness training delivered via mobile smoking cessation application (Craving to Quit, C2Q), (2) NCI's QuitSTART smoking cessation application (NCI), and (3) written cessation materials (Materials). Adolescents (n = 146) smoking 5 or more cigarettes per day were recruited. Interventions were implemented over four weeks and study assessments were collected at baseline and 3- and 6- month follow-up, including self-reported 7-day point prevalence abstinence, program usage, smoking-related measures, and psychosocial factors.ResultsOverall cotinine-validated abstinence at 6 months was 15.8% and was similar between conditions. Odds of abstinence increased with each quartile increase in app/materials use with no significant differences between conditions (OR=1.60 (C2Q), 1.66 (Materials), and 2.69 (NCI)). Of participants still smoking at 6 months, for each quartile increase in engagement the number of cigarettes smoked in the previous 7 days showed a significantly greater decline in the C2Q condition (-5.71) compared to the Materials (-0.95) and NCI (+7.73) condition (p=0.02 for differences between conditions).ConclusionsCotinine-validated abstinence was similar between intervention conditions and tended to increase with greater engagement in each condition. Greater C2Q app engagement among continuing smokers was associated with a significantly greater decline in number of cigarettes smoked compared to the other conditions. The Craving to Quit (C2Q) mobile smoking cessation application with mindfulness training was feasible to use and has promise in assisting adolescents to quit or decrease cigarette smoking.Clinical trial registrationDeveloping a Smartphone App with Mindfulness Training for Teen Smoking Cessation: ClinicalTrials.gov Identifier: NCT02218281.
| S-EPMC7747804 | biostudies-literature
Project description:BACKGROUND:Smoking rates in the United States have been reduced in the past decades to 15% of the general population. However, up to 88% of people with psychiatric symptoms still smoke, leading to high rates of disease and mortality. Therefore, there is a great need to develop smoking cessation interventions that have adequate levels of usability and can reach this population. OBJECTIVE:The objective of this study was to report the rationale, ideation, design, user research, and final specifications of a novel smoking cessation app for people with serious mental illness (SMI) that will be tested in a feasibility trial. METHODS:We used a variety of user-centered design methods and materials to develop the tailored smoking cessation app. This included expert panel guidance, a set of design principles and theory-based smoking cessation content, development of personas and paper prototyping, usability testing of the app prototype, establishment of app's core vision and design specification, and collaboration with a software development company. RESULTS:We developed Learn to Quit, a smoking cessation app designed and tailored to individuals with SMI that incorporates the following: (1) evidence-based smoking cessation content from Acceptance and Commitment Therapy and US Clinical Practice Guidelines for smoking cessation aimed at providing skills for quitting while addressing mental health symptoms, (2) a set of behavioral principles to increase retention and comprehension of smoking cessation content, (3) a gamification component to encourage and sustain app engagement during a 14-day period, (4) an app structure and layout designed to minimize usability errors in people with SMI, and (5) a set of stories and visuals that communicate smoking cessation concepts and skills in simple terms. CONCLUSIONS:Despite its increasing importance, the design and development of mHealth technology is typically underreported, hampering scientific innovation. This report describes the systematic development of the first smoking cessation app tailored to people with SMI, a population with very high rates of nicotine addiction, and offers new design strategies to engage this population. mHealth developers in smoking cessation and related fields could benefit from a design strategy that capitalizes on the role visual engagement, storytelling, and the systematic application of behavior analytic principles to deliver evidence-based content.
| S-EPMC5790963 | biostudies-literature
Project description:While smartphone applications (apps) have been shown to enhance success with smoking cessation, no study has been conducted among young adult smokers aged 18-24 years in Thailand. Quit with US was developed based on the 5 A's model and self-efficacy theory. This single arm, pre-post study was conducted aiming to assess results after using Quit with US for 4 weeks. The primary outcome was a biochemically verified 7-day point prevalence of smoking abstinence. The secondary outcomes included smoking behaviors, knowledge and attitudes toward smoking and smoking cessation, and satisfaction and confidence in the smartphone app. A total number of 19 young adult smokers were included; most participants were males (68.4%) with the mean (SD) age of 20.42 (1.46) years. After 4 weeks of study, the primary outcome demonstrated a smoking cessation rate of 31.6%. All 19 participants expressed better smoking behaviors and better knowledge and attitudes toward smoking and smoking cessation. Further, they were satisfied with the smartphone app design and content and expressed confidence in using it. These findings provided preliminary evidence that Quit with US was found to be a potentially effective smoking cessation smartphone app for young adult smokers.
| S-EPMC8430656 | biostudies-literature
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).
| S-EPMC5424127 | biostudies-literature
Project description:IntroductionA lapse (any smoking) early in a smoking cessation attempt is strongly associated with reduced success. A substantial proportion of lapses are due to urges to smoke triggered by situational cues. Currently, no available interventions proactively respond to such cues in real time. Quit Sense is a theory-guided just-in-time adaptive intervention smartphone app that uses a learning tool and smartphone sensing to provide in-the-moment tailored support to help smokers manage cue-induced urges to smoke. The primary aim of this randomised controlled trial (RCT) is to assess the feasibility of delivering a definitive online efficacy trial of Quit Sense.Methods and analysesA two-arm parallel-group RCT allocating smokers willing to make a quit attempt, recruited via online adverts, to usual care (referral to the NHS SmokeFree website) or usual care plus Quit Sense. Randomisation will be stratified by smoking rate (<16 vs ≥16 cigarettes/day) and socioeconomic status (low vs high). Recruitment, enrolment, baseline data collection, allocation and intervention delivery will be automated through the study website. Outcomes will be collected at 6 weeks and 6 months follow-up via the study website or telephone, and during app usage. The study aims to recruit 200 smokers to estimate key feasibility outcomes, the preliminary impact of Quit Sense and potential cost-effectiveness, in addition to gaining insights on user views of the app through qualitative interviews.Ethics and disseminationEthics approval has been granted by the Wales NHS Research Ethics Committee 7 (19/WA/0361). The findings will be disseminated to the public, the funders, relevant practice and policy representatives and other researchers.Trial registration numberISRCTN12326962.
| S-EPMC8076923 | biostudies-literature
Project description:Pregnant smokers may benefit from digital smoking cessation interventions, but few have been designed for this population. The aim was to transparently report the development of a smartphone app designed to aid smoking cessation during pregnancy. The development of a smartphone app ('SmokeFree Baby') to help pregnant women stop smoking was guided by frameworks for developing complex interventions, including the Medical Research Council (MRC), Multiphase Optimization Strategy (MOST) and Behaviour Change Wheel (BCW). Two integrative behaviour change theories provided the theoretical base. Evidence from the scientific literature and behaviour change techniques (BCTs) from the BCT Taxonomy v1 informed the intervention content. The app was developed around five core modules, each with a distinct intervention target (identity change, stress management, health information, promoting use of face-to-face support and behavioural substitution) and available in a 'control' or 'full' version. SmokeFree Baby has been developed as part of a multiphase intervention optimization to identify the optimum combination of intervention components to include in smartphone apps to help pregnant smokers stop smoking.
| S-EPMC5110502 | biostudies-literature
Project description:IntroductionAlthough engagement is generally predictive of positive outcomes in technology-based behavioral change interventions, engagement measures remain largely atheoretical and lack treatment-specificity. This study examines the extent to which adherence measures based on the underlying behavioral change theory of an Acceptance and Commitment Therapy (ACT) app for smoking cessation predict smoking outcomes, and user characteristics associated with adherence.MethodsStudy sample was adult daily smokers in a single arm pilot study (n=84). Using the app's log file data, we examined measures of adherence to four key components of the ACT behavior change model as predictors of smoking cessation and reduction. We also examined baseline user characteristics associated with adherence measures that predict smoking cessation.ResultsFully adherent users (24%) were over four times more likely to quit smoking (OR=4.45; 95% CI=1.13, 17.45; p=0.032). Both an increase in tracking the number of urges passed (OR=1.02; 95% CI=1.00, 1.03; p=0.043) and ACT modules completed (OR=1.27; 95% CI=1.01, 1.60; p=0.042) predicted cessation. Lower baseline acceptance of cravings was associated with over four times higher odds of full adherence (OR=4.59; 95% CI=1.35, 15.54; p=0.014).ConclusionsFull adherence and use of specific ACT theory-based components of the app predicted quitting. Consistent with ACT theory, users with low acceptance were most likely to adhere to the app. Further research is needed on ways to promote app engagement.
| S-EPMC5501958 | biostudies-literature
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).
| S-EPMC5856923 | biostudies-other