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A Digital Smoking Cessation Program for Heavy Drinkers: Pilot Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Heavy 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. OBJECTIVE:This 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. METHODS:Participants (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. RESULTS:Participants 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%; ?21=6.2; P=.01). CONCLUSIONS:This 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 REGISTRATION:ClinicalTrials.gov NCT03068611; https://clinicaltrials.gov/ct2/show/NCT03068611.

SUBMITTER: Kahler CW

PROVIDER: S-EPMC7308890 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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A Digital Smoking Cessation Program for Heavy Drinkers: Pilot Randomized Controlled Trial.

Kahler Christopher W CW Cohn Amy M AM Costantino Catherine C Toll Benjamin A BA Spillane Nichea S NS Graham Amanda L AL

JMIR formative research 20200608 6

<h4>Background</h4>Heavy 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.<h4>Objective</h4>This pilot randomized controlled trial aimed to examine the feasibility, acceptability, and effect sizes of an automated digital ...[more]

PMID: 32348286

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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:BackgroundDespite promising data in Western countries, there is a dearth of research into the efficacy of text messaging-based smoking cessation programs in other settings, including the Middle East, where smoking prevalence rates are higher.ObjectiveThis paper reports cessation rates observed in SMS Turkey, a text messaging-based smoking cessation program for adult smokers in Ankara, Turkey.MethodsThis study was a small-scale, parallel-group randomized controlled trial (RCT) conducted in Ankara, Turkey. Participants were adult daily smokers who were seriously thinking about quitting in the next 15 days and living in Ankara, Turkey. The text messaging intervention, SMS Turkey, provided 6 weeks of daily messages aimed at giving participants skills to help them quit smoking. Messages were sent in an automated fashion, except 2 days and 7 days after the initial quit day. On days 2 and 7, the research assistant manually assigned participants to content "paths" based on whether they were still not smoking or had relapsed. The control arm received a brochure that provided similar information about smoking cessation. The main outcome measure was self-reported 3-month sustained abstinence, verified by carbon monoxide (CO) readings. Neither participants nor researchers were blinded to arm assignment.ResultsThe 151 participants were randomly assigned to 1 of 2 groups: 76 to the SMS Turkey intervention group and 75 to the brochure control group. Using intention to treat, all 151 participants were included in analyses. Three-month cessation trends were not significantly higher in the intervention group: 11% intervention vs 5% control had quit (χ(2)(1)=1.4, P=.24; R(2)=2.0, 95% CI 0.62-6.3). When the sample was stratified by sex, female intervention participants (14%, n=5) were significantly more likely to have quit at 3 months than female control participants (0%, n=0; χ(2)(1)=3.7, P=.05). Among light smokers (ie, those smoking less than 20 cigarettes per day), intervention participants (17%, n=5) also were significantly more likely to have quit compared to control participants (0%, n=0; χ(2)(1)=5.3, P=.02). We noted no difference in cessation rates for males or heavy smokers. Participants experienced significant technology problems during the study. Some participants received duplicate text messages at least once during the trial; others failed to receive some program messages. Neither receiving duplicate messages (χ(2)(1)=0.12, P=.73), or missing 5 or more program messages (χ(2)(1)=0.75, P=.39) negatively affected quitting rates.ConclusionsAlthough the study was not powered to detect statistically significant differences, as the primary aim was to provide estimates of effect size that could be used to better inform a power analysis for a larger trial, findings provide optimism that SMS Turkey may be able to affect quitting rates in environments with high smoking prevalence, such as Ankara, Turkey. The SMS Turkey software program did not work as well as it did 2 years previous. The system will need to be updated to maintain software compatibility with ongoing technology evolution.Trial registrationClinicaltrials.gov NCT00912795 http://clinicaltrials.gov/ct2/show/NCT00912795 (Archived by WebCite® at http://www.webcitation.org/6Ch1cIA8l).

Project description:BackgroundDespite the declining prevalence of cigarette smoking in the United States, socioeconomically disadvantaged veterans receiving care from the Veterans Health Administration have a high prevalence of smoking. Currently, available treatment options for these veterans focus on tobacco users who are ready to quit and have limited reach. Consequently, there is a great need for accessible, effective smoking cessation interventions for veterans at all levels of readiness to quit smoking.ObjectiveTo address these needs, we developed Vet Flexiquit, a web-based Acceptance and Commitment Therapy program for veterans, and evaluated its acceptability (primary aim), efficacy, and impact on theory-based change processes relative to the National Cancer Institute's SmokefreeVET program in a pilot randomized controlled trial.MethodsParticipants (N=49) were randomized 1:1 to receive either the Vet Flexiquit (n=25) or SmokefreeVET (n=24) web program. Both groups received SMS text messages as part of the intervention for 6 weeks. Both interventions are fully automated and self-guided. Primary outcome data were collected at 3 months after the randomization. Self-reported smoking abstinence was biochemically verified using saliva cotinine. Multivariable logistic regression, negative binomial regression, and linear regression models were used to evaluate the association between the treatment arm and outcomes of interest.ResultsAcceptability, as measured by overall treatment satisfaction, was high and similar across treatment arms: 100% (17/17) for Vet Flexiquit and 95% (18/19) for SmokefreeVET. Acceptability, as measured by utilization, was more modest (log-ins: M=3.7 for Vet Flexiquit and M=3.2 for SmokefreeVET). There were no statistically significant differences between treatment arms for any acceptability measures. Similarly, there were no statistically significant differences between treatment arms in the secondary outcomes of smoking cessation or change in Acceptance and Commitment Therapy's theory-based processes. In open-ended survey responses, some veterans in both treatment arms expressed interest in having support from a professional or peer to enhance their experience, as well as an expanded SMS text messaging program.ConclusionsBoth programs had high ratings of acceptability, limited utilization, and a similar impact on cessation and cessation processes. Taken together with the qualitative data suggesting that additional support may enhance participants' experience of both programs, these preliminary findings suggest that the programs may have similar outcomes among veterans who are looking for a digital cessation treatment option and that integrating provider or peer support and enhancing the SMS text messaging program holds promise as a means of boosting engagement and outcomes for both programs.Trial registrationClinicalTrials.gov NCT04502524; https://clinicaltrials.gov/ct2/show/NCT04502524.

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: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:BackgroundIncreased smartphone ownership has led to the development of mobile smoking cessation programs. Although the related body of evidence, gathered through the conduct of randomized controlled trials (RCTs), has grown in quality and rigor, there is a need for longer-term data to assess associated smoking cessation durability.ObjectiveThe primary aim was to compare smoking cessation outcomes at 52 weeks in adult smokers randomized to a mobile smoking cessation program, Pivot (intervention), versus QuitGuide (control). The secondary aims included comparison of other smoking-related behaviors, outcomes and participant feedback, and exploratory analyses of baseline factors associated with smoking cessation.MethodsIn this remote pilot RCT, cigarette smokers in the United States were recruited on the web. Participants were offered 12 weeks of free nicotine replacement therapy (NRT). Data were self-reported via a web-based questionnaire with videoconference biovalidation in participants who reported 7-day point-prevalence abstinence (PPA). Outcomes focused on cessation rates with additional assessment of quit attempts, cigarettes per day (CPD), self-efficacy via the Smoking Abstinence Self-Efficacy Questionnaire, NRT use, and participant feedback. Cessation outcomes included self-reported 7- and 30-day PPA, abstinence from all tobacco products, and continuous abstinence. PPA and continuous abstinence were biovalidated using witnessed breath carbon monoxide samples. Exploratory post hoc regression analyses were performed to identify baseline variables associated with smoking cessation.ResultsParticipants comprised 188 smokers (n=94, 50% in the Pivot group and n=94, 50% in the QuitGuide group; mean age 46.4, SD 9.2 years; n=104, 55.3% women; n=128, 68.1% White individuals; mean CPD 17.6, SD 9.0). Several cessation rates were higher in the Pivot group (intention to treat): self-reported continuous abstinence was 20% (19/94) versus 9% (8/94; P=.03) for QuitGuide, biochemically confirmed abstinence was 31% (29/94) versus 18% (17/94; P=.04) for QuitGuide, and biochemically confirmed continuous abstinence was 19% (18/94) versus 9% (8/94; P=.046) for QuitGuide. More Pivot participants (93/94, 99% vs 80/94, 85% in the QuitGuide group; P<.001) placed NRT orders (mean 3.3, SD 2.0 vs 1.8, SD 1.6 for QuitGuide; P<.001). Pivot participants had increased self-efficacy via the Smoking Abstinence Self-Efficacy Questionnaire (mean point increase 3.2, SD 7.8, P<.001 vs 1.0, SD 8.5, P=.26 for QuitGuide). QuitGuide participants made more mean quit attempts (7.0, SD 6.3 for Pivot vs 9.5, SD 7.5 for QuitGuide; P=.01). Among those who did not achieve abstinence, QuitGuide participants reported greater CPD reduction (mean -34.6%, SD 35.5% for Pivot vs -46.1%, SD 32.3% for QuitGuide; P=.04). Among those who reported abstinence, 90% (35/39) of Pivot participants and 90% (26/29) of QuitGuide participants indicated that their cessation program helped them quit.ConclusionsThis pilot RCT supports the long-term effectiveness of the Pivot mobile smoking cessation program, with abstinence rates durable to 52 weeks.Trial registrationClinicalTrials.gov NCT04955639; https://clinicaltrials.gov/ct2/show/NCT04955639.

Dataset Information

A Digital Smoking Cessation Program for Heavy Drinkers: Pilot Randomized Controlled Trial.

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A Digital Smoking Cessation Program for Heavy Drinkers: Pilot Randomized Controlled Trial.

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