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A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation: Randomized Controlled Trial.

ABSTRACT: 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.

SUBMITTER: Carrasco-Hernandez L

PROVIDER: S-EPMC7215523 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation: Randomized Controlled Trial.

Carrasco-Hernandez Laura L Jódar-Sánchez Francisco F Núñez-Benjumea Francisco F Moreno Conde Jesús J Mesa González Marco M Civit-Balcells Antón A Hors-Fraile Santiago S Parra-Calderón Carlos Luis CL Bamidis Panagiotis D PD Ortega-Ruiz Francisco F

JMIR mHealth and uHealth 20200427 4

<h4>Background</h4>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 no ...[more]

PMID: 32338624

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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.

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.

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.

Project description:BACKGROUND:Several large studies have shown that the risk of cardiovascular, respiratory, and wound-healing complications (including death) within 30 days of surgery is greater for smokers than for nonsmokers. However, there is evidence that even short-term perioperative smoking cessation may reduce postoperative morbidity. Over the past few years, it has become more evident that short message service (SMS)-based interventions can help individuals quit smoking. OBJECTIVE:The overall aim of this project is to fill the knowledge gap on whether an SMS-based smoking-cessation intervention can be effective in helping patients stop smoking perioperatively. The aim of this trial is to evaluate the effectiveness of an SMS-based intervention on smoking behavior of patients undergoing elective surgery. METHODS:A two-arm parallel-group randomized controlled trial will be conducted at 20 surgical departments in southeast Sweden. Smokers undergoing elective surgery who own a mobile phone will be included. Power calculations indicate that it will be necessary to randomize 434 participants. One group will be given access to a novel 12-week SMS program, which includes daily SMS messages with behavior change-enforcing text content and hyperlinks to interactive modules, while the other group will not be given access to the intervention. Both groups will have access to the surgical departments' current routine for smoking cessation prior to surgery. Primary outcome measures, prolonged abstinence, and point prevalence of smoking cessation will be measured through questionnaires at 3, 6, and 12 months after randomization. Logistic regression models adjusted using baseline characteristics will be explored to identify potential effects of the intervention. RESULTS:Recruitment started in late October 2018 and is expected to last for a maximum of 30 months. The first results are expected to be available approximately 3 months after the final date of recruitment. CONCLUSIONS:Owing to the structural problems and scarcity of time and resources, patients at most Swedish surgical departments are simply instructed to quit smoking, and perhaps, referred to a primary health care clinic. An SMS-based smoking-cessation aid can be effective in helping individuals quit smoking and is a very simple and time-efficient tool for surgical departments to use. TRIAL REGISTRATION:ISRCTN Registry ISRCTN33869008; http://www.isrctn.com/ISRCTN33869008. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/12511.

Project description:BACKGROUND:Smoking 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. OBJECTIVE:We 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). METHODS:The 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. RESULTS:Of 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. CONCLUSIONS:Social 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 REGISTRATION:ClinicalTrials.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.

Project description:BackgroundApproximately 2 million Chinese people die annually from tobacco-related diseases, mostly men; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation advice or support. A social network-based gamified smoking cessation intervention (SCAMPI: Smoking Cessation App for Chinese Male: Pilot Intervention) is designed to help Chinese male smokers to quit smoking.ObjectiveThis paper aims to present the protocol of a study examining the preliminary effectiveness of SCAMPI by comparing the prolonged abstinence rate of a group of users with a comparator group during a 6-week follow-up period.MethodsA two-arm pilot randomized controlled trial was conducted to assess the preliminary effectiveness and acceptability of the SCAMPI program as a smoking cessation intervention. After initial web-based screening, the first 80 eligible individuals who had gone through the required registration process were registered as participants of the trial. Participants were randomly allocated to the intervention group (n=40) and the control group (n=40). Participants in the intervention group used the full version of the SCAMPI program, which is a Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users. The program delivers a range of smoking cessation approaches, including helping users to make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, providing information about smoking harms, motivational messages to help users overcome urges, providing standardized tests to users for assessing their levels of nicotine dependence and lung health, and providing a platform to encourage social support between users. Participants in the control group used the restricted version of the SCAMPI program (placebo app).ResultsRecruitment for this project commenced in January 2019 and proceeded until March 2019. Follow-up data collection was commenced and completed by June 2019. The primary outcome measure of the study was the 30-day bio-verified smoking abstinence at the 6-week follow-up (self-reported data verified by the Nicotine Cotinine Saliva Test). The secondary outcome measures of the study included participants' cigarette consumption reduction (compared baseline daily cigarette consumption with end-of-trial daily cigarette consumption), participants' 7-day smoking abstinence at 4-week and 6-week follow-up (self-reported), participants' 30-day smoking abstinence at 6-week follow-up (self-reported data only), and participants' acceptability and satisfaction levels of using the SCAMPI program (measured by the Mobile App Rating Scale questionnaire).ConclusionsIf the SCAMPI program is shown to be preliminary effective, the study will be rolled out to be a future trial with a larger sample size and longer follow-up (6 months) to identify if it is an effective social network-based tool to support Chinese male smokers to quit smoking.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12618001089224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375381.International registered report identifier (irrid)RR1-10.2196/18071.

Project description:BackgroundCigarette smoking remains the leading cause of preventable illness and death, underscoring ongoing need for evidence-based solutions. Pivot, a US Clinical Practice Guideline-based mobile smoking cessation program, comprises a personal carbon monoxide breath sensor; a smartphone app; in-app, text-based human-provided coaching; nicotine replacement therapy; and a moderated web-based community. Promising Pivot cohort studies have established the foundation for comparative assessment.ObjectiveThis study aimed to compare engagement, retention, attitudes toward quitting smoking, smoking behavior, and participant feedback between Pivot and QuitGuide, a US Clinical Practice Guideline-based smoking cessation smartphone app from the National Cancer Institute.MethodsIn this remote pilot randomized controlled trial, cigarette smokers in the United States were recruited on the web and randomized to Pivot or QuitGuide. Participants were offered 12 weeks of free nicotine replacement therapy. Data were self-reported via weekly web-based questionnaires for 12 weeks and at 26 weeks. Outcomes included engagement and retention, attitudes toward quitting smoking, smoking behavior, and participant feedback. The primary outcome was self-reported app openings at 12 weeks. Cessation outcomes included self-reported 7- and 30-day point prevalence abstinence (PPA), abstinence from all tobacco products, and continuous abstinence at 12 and 26 weeks. PPA and continuous abstinence were biovalidated via breath carbon monoxide samples.ResultsParticipants comprised 188 smokers (94 Pivot and 94 QuitGuide): mean age 46.4 (SD 9.2) years, 104 (55.3%) women, 128 (68.1%) White individuals, and mean cigarettes per day 17.6 (SD 9.0). Engagement via mean "total app openings through 12 weeks" (primary outcome) was Pivot, 157.9 (SD 210.6) versus QuitGuide, 86.5 (SD 66.3; P<.001). Self-reported 7-day PPA at 12 and 26 weeks was Pivot, 35% (33/94) versus QuitGuide, 28% (26/94; intention to treat [ITT]: P=.28) and Pivot, 36% (34/94) versus QuitGuide, 27% (25/94; ITT: P=.12), respectively. Self-reported 30-day PPA at 12 and 26 weeks was Pivot, 29% (27/94) versus QuitGuide, 22% (21/94; ITT: P=.32) and Pivot, 32% (30/94) versus QuitGuide, 22% (21/94; ITT: P=.12), respectively. The biovalidated abstinence rate at 12 weeks was Pivot, 29% (27/94) versus QuitGuide, 13% (12/94; ITT: P=.008). Biovalidated continuous abstinence at 26 weeks was Pivot, 21% (20/94) versus QuitGuide, 10% (9/94; ITT: P=.03). Participant feedback, including ease of setup, impact on smoking, and likelihood of program recommendation were favorable for Pivot.ConclusionsIn this randomized controlled trial comparing the app-based smoking cessation programs Pivot and QuitGuide, Pivot participants had higher engagement and biovalidated cessation rates and more favorable user feedback at 12 and 26 weeks. These findings support Pivot as an effective, durable mobile smoking cessation program.Trial registrationClinicalTrials.gov NCT04955639; https://clinicaltrials.gov/ct2/show/NCT04955639.

Project description:INTRODUCTION:Far too few smokers receive recommended interventions at their healthcare visits, highlighting the importance of identifying effective, low-cost smoking interventions that can be readily delivered. Self-help interventions (e.g., written materials) would meet this need, but they have shown low efficacy. The purpose of this RCT was to determine the efficacy of a self-help intervention with increased duration and intensity. DESIGN:Randomized parallel trial design involving enrollment between April 2010 and August 2011 with follow-up data for 24 months. SETTING/PARTICIPANTS:U.S. national sample of daily smokers (N=1,874). INTERVENTION:Participants were randomized to one of three arms of a parallel trial design: Traditional Self-Help (TSH, n=638), Standard Repeated Mailings (SRM, n=614), or Intensive Repeated Mailings (IRM, n=622). TSH received an existing self-help booklet for quitting smoking. SRM received eight different cessation booklets mailed over a 12-month period. IRM received monthly mailings of ten booklets and additional material designed to enhance social support over 18 months. MAIN OUTCOME MEASURES:The primary outcome was 7-day point-prevalence abstinence collected at 6, 12, 18, and 24 months. RESULTS:Data were analyzed between 2013 and 2015. A dose-response effect was found across all four follow-up points. For example, by 24 months, IRM produced the highest abstinence rate (30.0%), followed by SRM (24.4%) and TSH (18.9%). The difference in 24-month abstinence rates between IRM and TSH was 11.0% (95% CI=5.7%, 16.3%). Cost analyses indicated that, compared with TSH, the incremental cost per quitter who received SRM and IRM was $560 and $361, respectively. CONCLUSIONS:Self-help interventions with increased intensity and duration resulted in significantly improved abstinence rates that extended 6 months beyond the end of the intervention. Despite the greater intensity, the interventions were highly cost effective, suggesting that widespread dissemination in healthcare settings could greatly enhance quitting. TRIAL REGISTRATION:This study is registered at www.clinicaltrials.gov NCT01352195.

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A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation: Randomized Controlled Trial.

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A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation: Randomized Controlled Trial.

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