Evaluation of the Tobbstop Mobile App for Smoking Cessation: Cluster Randomized Controlled Clinical Trial.
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SUBMITTER: Palleja-Millan M
PROVIDER: S-EPMC7381259 | biostudies-literature | 2020 Jun
REPOSITORIES: biostudies-literature
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Evaluation of the Tobbstop Mobile App for Smoking Cessation: Cluster Randomized Controlled Clinical Trial.
Pallejà-Millán Meritxell M Rey-Reñones Cristina C Barrera Uriarte Maria Luisa ML Granado-Font Esther E Basora Josep J Flores-Mateo Gemma G Duch Jordi J
JMIR mHealth and uHealth 20200626 6
<h4>Background</h4>Mobile apps provide an accessible way to test new health-related methodologies. Tobacco is still the primary preventable cause of death in industrialized countries, constituting an important public health issue. New technologies provide novel opportunities that are effective in the cessation of smoking tobacco.<h4>Objective</h4>This paper aims to evaluate the efficacy and usage of a mobile app for assisting adult smokers to quit smoking.<h4>Methods</h4>We conducted a cluster r ...[more]
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Project description:BackgroundMost smokers attempt to stop using cigarettes numerous times before successfully quitting. Cigarette cravings may undermine perceived competence to quit and thus constitute psychological threats to the individual's self-concept. Self-affirmation may promote smoking cessation by offsetting these threats.ObjectiveThis study examines whether self-affirmation is associated with smoking cessation in the context of a cessation app. Two types of self-affirmation are examined: tendency to spontaneously self-affirm, and self-affirmation inductions added to a publicly available smoking cessation app (Smoke-Free Quit Smoking Now). In addition, this study explores whether optimism and emotional states (happiness, anger, anxiousness, hopefulness, sadness) predict smoking cessation.MethodsAll users who met the inclusion criteria, provided consent to participate, and completed a baseline assessment, including all individual difference measures, were randomized to 1 of 4 conditions. Half of the participants were randomly assigned to complete a self-affirmation induction upon study entry. Orthogonally, half of the participants were randomly assigned to receive self-affirming text notifications during their quit attempt or to receive conventional notifications. The induction and the text notifications were fully automated, and all data were collected through self-assessments in the app. Self-reported smoking cessation was assessed 1 month and 3 months following study entry.ResultsThe study enrolled 7899 participants; 647 completed the 1-month follow-up. Using an intent-to-treat analysis at the 1-month follow-up, 7.2% (569/7899) of participants self-reported not smoking in the previous week and 6.4% (503/7899) self-reported not smoking in the previous month. Greater tendency to spontaneously self-affirm predicted a greater likelihood of cessation (P<.001) at 1 month after controlling for smoking-related variables. Neither self-affirmation induction influenced cessation. In addition, spontaneous self-affirmation did not moderate the relationship between self-affirmation inductions and cessation. Greater baseline sadness was associated with a lower likelihood of reporting successful cessation. Optimism predicted past-week cessation at the 1-month follow-up, and both happiness and anger predicted past-month cessation at the 1-month follow-up; however, none of these potential predictors moderated the relationship between self-affirmation conditions and successful cessation.ConclusionsSpontaneous self-affirmation may be an important psychological resource for managing threats to self-concept during the smoking cessation process. Sadness may hinder quit attempts. Future research can explicate how spontaneous versus induced self-affirmation can promote smoking cessation and examine boundary conditions for the effectiveness of disseminated self-affirmation interventions.Trial registrationISRCTN Registry 56646695; https://www.isrctn.com/ISRCTN56646695.
| S-EPMC7980123 | biostudies-literature
Project description:BackgroundSmoking is considered the main cause of preventable illness and early deaths worldwide. The treatment usually prescribed to people who wish to quit smoking is a multidisciplinary intervention, combining both psychological advice and pharmacological therapy, since the application of both strategies significantly increases the chance of success in a quit attempt.ObjectiveWe present a study protocol of a 12-month randomized open-label parallel-group trial whose primary objective is to analyze the efficacy and efficiency of usual psychopharmacological therapy plus the Social-Local-Mobile app (intervention group) applied to the smoking cessation process compared with usual psychopharmacological therapy alone (control group).MethodsThe target population consists of adult smokers (both male and female) attending the Smoking Cessation Unit at Virgen del Rocío University Hospital, Seville, Spain. Social-Local-Mobile is an innovative intervention based on mobile technologies and their capacity to trigger behavioral changes. The app is a complement to pharmacological therapies to quit smoking by providing personalized motivational messages, physical activity monitoring, lifestyle advice, and distractions (minigames) to help overcome cravings. Usual pharmacological therapy consists of bupropion (Zyntabac 150 mg) or varenicline (Champix 0.5 mg or 1 mg). The main outcomes will be (1) the smoking abstinence rate at 1 year measured by means of exhaled carbon monoxide and urinary cotinine tests, and (2) the result of the cost-effectiveness analysis, which will be expressed in terms of an incremental cost-effectiveness ratio. Secondary outcome measures will be (1) analysis of the safety of pharmacological therapy, (2) analysis of the health-related quality of life of patients, and (3) monitoring of healthy lifestyle and physical exercise habits.ResultsOf 548 patients identified using the hospital's electronic records system, we excluded 308 patients: 188 declined to participate and 120 did not meet the inclusion criteria. A total of 240 patients were enrolled: the control group (n=120) will receive usual psychopharmacological therapy, while the intervention group (n=120) will receive usual psychopharmacological therapy plus the So-Lo-Mo app. The project was approved for funding in June 2015. Enrollment started in October 2016 and was completed in October 2017. Data gathering was completed in November 2018, and data analysis is under way. The first results are expected to be submitted for publication in early 2019.ConclusionsSocial networks and mobile technologies influence our daily lives and, therefore, may influence our smoking habits as well. As part of the SmokeFreeBrain H2020 European Commission project, this study aims at elucidating the potential role of these technologies when used as an extra aid to quit smoking.Trial registrationClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/record/NCT03553173 (Archived by WebCite at http://www.webcitation.org/74DuHypOW).International registered report identifier (irrid)PRR1-10.2196/12464.
| S-EPMC6302230 | biostudies-literature
Project description:BACKGROUND:Smoking cessation is a persistent leading public health challenge. Mobile health (mHealth) solutions are emerging to improve smoking cessation treatments. Previous approaches have proposed supporting cessation with tailored motivational messages. Some managed to provide short-term improvements in smoking cessation. Yet, these approaches were either static in terms of personalization or human-based nonscalable solutions. Additionally, long-term effects were neither presented nor assessed in combination with existing psychopharmacological therapies. OBJECTIVE:This study aimed to analyze the long-term efficacy of a mobile app supporting psychopharmacological therapy for smoking cessation and complementarily assess the involved innovative technology. METHODS:A 12-month, randomized, open-label, parallel-group trial comparing smoking cessation rates was performed at Virgen del Rocío University Hospital in Seville (Spain). Smokers were randomly allocated to a control group (CG) receiving usual care (psychopharmacological treatment, n=120) or an intervention group (IG) receiving psychopharmacological treatment and using a mobile app providing artificial intelligence-generated and tailored smoking cessation support messages (n=120). The secondary objectives were to analyze health-related quality of life and monitor healthy lifestyle and physical exercise habits. Safety was assessed according to the presence of adverse events related to the pharmacological therapy. Per-protocol and intention-to-treat analyses were performed. Incomplete data and multinomial regression analyses were performed to assess the variables influencing participant cessation probability. The technical solution was assessed according to the precision of the tailored motivational smoking cessation messages and user engagement. Cessation and no cessation subgroups were compared using t tests. A voluntary satisfaction questionnaire was administered at the end of the intervention to all participants who completed the trial. RESULTS:In the IG, abstinence was 2.75 times higher (adjusted OR 3.45, P=.01) in the per-protocol analysis and 2.15 times higher (adjusted OR 3.13, P=.002) in the intention-to-treat analysis. Lost data analysis and multinomial logistic models showed different patterns in participants who dropped out. Regarding safety, 14 of 120 (11.7%) IG participants and 13 of 120 (10.8%) CG participants had 19 and 23 adverse events, respectively (P=.84). None of the clinical secondary objective measures showed relevant differences between the groups. The system was able to learn and tailor messages for improved effectiveness in supporting smoking cessation but was unable to reduce the time between a message being sent and opened. In either case, there was no relevant difference between the cessation and no cessation subgroups. However, a significant difference was found in system engagement at 6 months (P=.04) but not in all subsequent months. High system appreciation was reported at the end of the study. CONCLUSIONS:The proposed mHealth solution complementing psychopharmacological therapy showed greater efficacy for achieving 1-year tobacco abstinence as compared with psychopharmacological therapy alone. It provides a basis for artificial intelligence-based future approaches. TRIAL REGISTRATION:ClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/NCT03553173. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.2196/12464.
| S-EPMC7215523 | biostudies-literature
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:BackgroundMindfulness training shows promise for improving smoking cessation and lapse recovery, and between-session mobile health messages could enhance treatment engagement and effectiveness. Personalized, in-the-moment text messaging support could be particularly useful for low-income smokers with fewer smoking cessation resources.ObjectiveThis pilot study examined the feasibility of a text messaging program (iQuit Mindfully) as an adjunct to in-person Mindfulness-Based Addiction Treatment (MBAT) for smoking cessation.MethodsA total of 71 participants were randomly assigned to MBAT (n=33) or iQuit Mindfully (n=38; MBAT + between-session text messages); of these, 70% (50/71) were African American, and 61% (43/71) had an annual household income of US $30,000 or less. All participants received 8 weekly therapist-led group counseling sessions, nicotine patches, and self-help materials. Outcomes were feasibility (attrition, engagement, and participants' ratings), participants' feedback regarding the text messaging intervention, and smoking cessation (assessed in person).ResultsStrong retention was achieved (76% [54/71] at the end of treatment, and 89% [63/71] at 1-month follow-up). In the iQuit Mindfully group, engagement was high (88% [29/33] indicated reading all or most texts, and 89% [34/38] engaged in interactive texting), and participants provided positive ratings (on a 1-10 scale, average rating for recommending the program to others was 8.4 [SD 2.5]). Participants indicated benefiting from the texts (eg, appreciating encouraging reminders, coping strategies, and social support) and suggested improvements (eg, more personalization). Overall, biochemically confirmed smoking cessation rates were 22% (12/55) at the end of treatment and 19% (12/62) at 1-month follow-up, with no differences between conditions. Living below the poverty level predicted worse cessation outcomes at 1-month follow-up among participants receiving in-person only treatment (P=.03) but not among those receiving iQuit Mindfully.ConclusionsText messaging appears to be a feasible and acceptable modality for supporting mindfulness-based smoking cessation treatment. The availability of 24/7 text messaging might be particularly helpful for low-income smokers who have access to fewer cessation resources and experience significant day-to-day barriers to quitting.Trial registrationClinicalTrials.gov NCT03029819; https://clinicaltrials.gov/ct2/show/NCT03029819.
| S-EPMC6613894 | biostudies-literature
Project description:BACKGROUND:Smartphone apps for smoking cessation could offer easily accessible, highly tailored, intensive interventions at a fraction of the cost of traditional counseling. Although there are hundreds of publicly available smoking cessation apps, few have been empirically evaluated using a randomized controlled trial (RCT) design. The Smart-Treatment (Smart-T2) app is a just-in-time adaptive intervention that uses ecological momentary assessments (EMAs) to assess the risk for imminent smoking lapse and tailors treatment messages based on the risk of lapse and reported symptoms. OBJECTIVE:This 3-armed pilot RCT aimed to determine the feasibility and preliminary efficacy of an automated smartphone-based smoking cessation intervention (Smart-T2) relative to standard in-person smoking cessation clinic care and the National Cancer Institute's free smoking cessation app, QuitGuide. METHODS:Adult smokers who attended a clinic-based tobacco cessation program were randomized into groups and followed for 13 weeks (1 week prequitting through 12 weeks postquitting). All study participants received nicotine patches and gum and were asked to complete EMAs five times a day on study-provided smartphones for 5 weeks. Participants in the Smart-T2 group received tailored treatment messages after the completion of each EMA. Both Smart-T2 and QuitGuide apps offer on-demand smoking cessation treatment. RESULTS:Of 81 participants, 41 (50%) were women and 55 (68%) were white. On average, participants were aged 49.6 years and smoked 22.4 cigarettes per day at baseline. A total of 17% (14/81) of participants were biochemically confirmed 7-day point prevalence abstinent at 12 weeks postquitting (Smart-T2: 6/27, 22%, QuitGuide: 4/27, 15%, and usual care: 4/27, 15%), with no significant differences across groups (P>.05). Participants in the Smart-T2 group rated the app positively, with most participants agreeing that they can rely on the app to help them quit smoking, and endorsed the belief that the app would help them stay quit, and these responses were not significantly different from the ratings given by participants in the usual care group. CONCLUSIONS:Dynamic smartphone apps that tailor intervention content in real time may increase user engagement and exposure to treatment-related materials. The results of this pilot RCT suggest that smartphone-based smoking cessation treatments may be capable of providing similar outcomes to traditional, in-person counseling. TRIAL REGISTRATION:ClinicalTrials.gov NCT02930200; https://clinicaltrials.gov/show/NCT02930200.
| S-EPMC7091024 | biostudies-literature
Project description:BackgroundAround 2 million Chinese people, mostly men, die annually from tobacco-related diseases; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation support.ObjectiveThis study aimed to test the preliminary effectiveness and feasibility for a mobile social network (WeChat)-based smoking cessation intervention (SCAMPI program) among Chinese male smokers.MethodsChinese male smokers aged 25-44 years were recruited online from WeChat, the most widely used social media platform in China. Individuals using other smoking cessation interventions or who lacked capacity to provide online informed consent were excluded. Participants were randomly assigned (1:1) to intervention or control groups. Neither participants nor researchers were masked to assignment. The trial was fully online. All data were collected via WeChat. The intervention group received access to the full-version SCAMPI program, a Chinese-language smoking cessation program based on the Behaviour Change Wheel framework and relevant cessation guidelines. Specific intervention functions used in the program include: planning to help users make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, information about smoking harms, motivational messages to help users overcome urges, standardized tests for users to assess their levels of nicotine dependence and lung health, as well as a social platform to encourage social support between users. The control group had access to a static WeChat page of contacts for standard smoking cessation care. Both groups received incentive credit payments for participating. The primary outcome was 30-day biochemically verified smoking abstinence at 6 weeks after randomization, with missing data treated as not quitting. Secondary outcomes were other smoking status measures, reduction of cigarette consumption, study feasibility (recruitment and retention rate), and acceptability of and satisfaction with the program.ResultsThe program recorded 5736 visitors over a 13-day recruitment period. We recruited 80 participants who were randomly allocated to two arms (n=40 per arm). At 6 weeks, 36 of 40 (90%) intervention participants and 35 of 40 (88%) control participants provided complete self-reported data on their daily smoking status via WeChat. Biochemically verified smoking abstinence at 6 weeks was determined for 10 of 40 (25%) intervention participants and 2 of 40 (5%) control participants (RR=5, 95% CI 1.2-21.4, P=.03). In the intervention group, the calculator function, motivational messages, and health tests were underused (less than once per week per users). Participants rated their satisfaction with the intervention program as 4.56 out of 5.00.ConclusionsOur program is a novel, accessible, and acceptable smoking cessation intervention for Chinese male smokers. A future trial with a greater sample size and longer follow-up will identify if it is as effective as these preliminary data suggest.Trial registrationANZCTR registry, ACTRN12618001089224; https://tinyurl.com/y536n7sx.International registered report identifier (irrid)RR2-18071.
| S-EPMC7647814 | biostudies-literature
Project description:BackgroundAdolescence and young adulthood are critical times of initiation and progression to daily use of tobacco. However, it is difficult to recruit young adults to traditional smoking cessation and retention rates are typically low. Smartphone cessation applications (apps) can provide real-time responses to smoking urges and related cues, which are known to be important factors in lapse and relapse. Given the popularity of smartphones among young adults and the considerably higher download rates of commercially developed apps compared to research-based apps, there is a need to design pragmatic studies that evaluate commercial tobacco cessation apps. The aims of this pilot study are to assess the impact on tobacco cessation of using a smartphone app compared with usual care and to generate feasibility data to inform a future fully powered clinical trial.MethodsWe will conduct an open randomized controlled trial with parallel groups. Participants will be selected from hospitalized patients and must be aged 18-30 years, interested in cessation, smoked > 5 cigarettes/day over the past 30 days, and own an Apple or Android smartphone. Participants who are eligible will be randomized to either a smartphone experimental group or patient-initiated follow up (usual care). As this study seeks to assess feasibility, the primary data will include (1) recruitment rates, (2) retention rates, and (3) adherence, measured through user engagement with the app.DiscussionThis pilot trial will be the first to evaluate a commercially available smartphone app for tobacco cessation in a hospitalized setting. Data generated by this study can be used for larger fully powered trials such as comparative effectiveness studies against apps developed by academics or health scientists based on behavioral theories, or cost-effectiveness analyses of mobile interventions.Trial registrationClinicalTrials.gov, NCT03538678 . Registered on 28 May 2018.
| S-EPMC6390617 | biostudies-literature
Project description:BackgroundThe prevalence of smoking in Spain is high in both men and women. The aim of our study was to evaluate the role of gender in the effectiveness of a specific smoking cessation intervention conducted in Spain.MethodsThis study was a secondary analysis of a cluster randomized clinical trial in which the randomization unit was the Basic Care Unit (family physician and nurse who care for the same group of patients). The intervention consisted of a six-month period of implementing the recommendations of a Clinical Practice Guideline. A total of 2,937 current smokers at 82 Primary Care Centers in 13 different regions of Spain were included (2003-2005). The success rate was measured by a six-month continued abstinence rate at the one-year follow-up. A logistic mixed-effects regression model, taking Basic Care Units as random-effect parameter, was performed in order to analyze gender as a predictor of smoking cessation.ResultsAt the one-year follow-up, the six-month continuous abstinence quit rate was 9.4% in men and 8.5% in women (p = 0.400). The logistic mixed-effects regression model showed that women did not have a higher odds of being an ex-smoker than men after the analysis was adjusted for confounders (OR adjusted = 0.9, 95% CI = 0.7-1.2).ConclusionsGender does not appear to be a predictor of smoking cessation at the one-year follow-up in individuals presenting at Primary Care Centers. CLINICALTRIALS.GOV IDENTIFIER: NCT00125905.
| S-EPMC3125366 | 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