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Mindfulness-Based Smoking Cessation Enhanced With Mobile Technology (iQuit Mindfully): Pilot Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Mindfulness 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. OBJECTIVE:This 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. METHODS:A 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). RESULTS:Strong 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. CONCLUSIONS:Text 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 REGISTRATION:ClinicalTrials.gov NCT03029819; https://clinicaltrials.gov/ct2/show/NCT03029819.

SUBMITTER: Spears CA

PROVIDER: S-EPMC6613894 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Mindfulness-Based Smoking Cessation Enhanced With Mobile Technology (iQuit Mindfully): Pilot Randomized Controlled Trial.

Spears Claire Adams CA Abroms Lorien C LC Glass Carol R CR Hedeker Donald D Eriksen Michael P MP Cottrell-Daniels Cherell C Tran Binh Q BQ Wetter David W DW

JMIR mHealth and uHealth 20190624 6

<h4>Background</h4>Mindfulness 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.<h4>Objective</h4>This pilot study examined the feasibility of a text messaging program (iQuit Mindfully) as an adjunct to in-person Mindfulness-Based Addi ...[more]

PMID: 31237242

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Project description:BackgroundSmoking is the leading cause of premature death, and low-income adults experience disproportionate burden from tobacco. Mindfulness interventions show promise for improving smoking cessation. A text messaging program "iQuit Mindfully" was developed to deliver just-in-time support for quitting smoking among low-income adults. A pilot study of iQuit Mindfully was conducted in spring 2020, during the COVID-19 pandemic, among low-income and predominantly African American smokers.ObjectiveThis pilot study examined the acceptability and feasibility of delivering Mindfulness-Based Addiction Treatment via mHealth during the COVID-19 pandemic.MethodsParticipants were adult cigarette smokers (n=23), of whom 8 (34.8%) were female, 19 (82.6%) were African American, and 18 (78.3%) had an annual income of <US $24,000. They were randomly assigned to either 8 weeks of iQuit Mindfully as a fully automated standalone intervention or iQuit Mindfully in combination with therapist-led in-person group treatment. For participant safety, in-person mindfulness groups were transitioned to the internet and assessments also took place over the internet. Survey questions asked participants about changes in their stress, smoking habits and quit attempts, and their perceptions of the mindfulness and text messaging intervention in the context of the pandemic.ResultsMost participants (n=15 of 21, 71.4%) indicated a change in stress due to the pandemic, of whom 14 (93.3%) indicated higher stress. Participants shared concerns about finances, homelessness, health, and social isolation. Most (n=17 of 21, 80.9%) believed that smoking increases the risk of contracting COVID-19, and although that was motivating for some, others expressed lower motivation to quit smoking because of higher stress. Most (n=18 of 21, 85.7%) stated that practicing mindfulness was helpful during the pandemic. Mean ratings of the helpfulness of text messages and the extent to which they would recommend the program to others were 7.1 (median 8 on a 10-point scale, SD 2.9) and 8.2 (median 9, SD 2.5), respectively. Through open-ended program evaluations, participants shared details about how mindfulness practices and the text messages helped them manage stress and feel a sense of social support during the pandemic. Moreover, 10 of 19 (52.6%) of participants achieved 7-day abstinence from smoking, with no differences between conditions.ConclusionsThis study supports the promise of text messaging and the use of teleconferencing to provide mindfulness and smoking cessation services to underserved populations during a pandemic.

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: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: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.

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:BackgroundHeavy drinking (HD) is far more common among smokers compared with nonsmokers and interferes with successful smoking cessation. Alcohol-focused smoking cessation interventions delivered by counselors have shown promise, but digital versions of these interventions-which could have far greater population reach-have not yet been tested.ObjectiveThis pilot randomized controlled trial aimed to examine the feasibility, acceptability, and effect sizes of an automated digital smoking cessation program that specifically addresses HD using an interactive web-based intervention with an optional text messaging component.MethodsParticipants (83/119, 69.7% female; 98/119, 82.4% white; mean age 38.0 years) were daily smokers recruited on the web from a free automated digital smoking cessation program (BecomeAnEX.org, EX) who met the criteria for HD: women drinking 8+ drinks/week or 4+ drinks on any day and men drinking 15+ drinks/week or 5+ drinks on any day. Participants were randomized to receive EX with standard content (EX-S) or an EX with additional content specific to HD (EX-HD). Outcomes were assessed by web-based surveys at 1 and 6 months.ResultsParticipants reported high satisfaction with the website and the optional text messaging component. Total engagement with both EX-S and EX-HD was modest, with participants visiting the website a median of 2 times, and 52.9% of the participants enrolled to receive text messages. Participants in both the conditions showed substantial, significant reductions in drinking across 6 months of follow-up, with no condition effects observed. Although smoking outcomes tended to favor EX-HD, the condition effects were small and nonsignificant. A significantly smaller proportion of participants in EX-HD reported having a lapse back to smoking when drinking alcohol (7/58, 16%) compared with those in EX-S (18/61, 41%; χ21=6.2; P=.01).ConclusionsThis is the first trial to examine a digital smoking cessation program tailored to HD smokers. The results provide some initial evidence that delivering such a program is feasible and may reduce the risk of alcohol-involved smoking lapses. However, increasing engagement in this and other web-based interventions is a crucial challenge to address in future work.Trial registrationClinicalTrials.gov NCT03068611; https://clinicaltrials.gov/ct2/show/NCT03068611.

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Mindfulness-Based Smoking Cessation Enhanced With Mobile Technology (iQuit Mindfully): Pilot Randomized Controlled Trial.

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Mindfulness-Based Smoking Cessation Enhanced With Mobile Technology (iQuit Mindfully): Pilot Randomized Controlled Trial.

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