Conversational Chatbot for Cigarette Smoking Cessation: Report of the User-Centered Design Eleven Step Development Process.

BACKGROUND: Conversational chatbots are an emerging digital intervention for smoking cessation. No studies have reported on the entire development process of a cessation chatbot. OBJECTIVE: To describe the user-centered design development process for a novel and comprehensive quit smoking conversational chatbot called "QuitBot." METHODS: The four years of formative research for developing QuitBot followed an eleven-step process: (1) specifying a conceptual model, (2) conducting content analysis of existing interventions (63 hours of intervention transcripts), (3) assessing user needs, (4) developing the chat's persona ("personality"), (5) prototyping content and persona, (6) developing full functionality, (7) programming the QuitBot, (8) conducting a diary study, (9) conducting a pilot randomized trial, (10) reviewing results of the trial, and (11) adding a free-form question and answer (QnA) function, based on user feedback from pilot trial results. The process of adding a QnA function itself involved a three-step process: (a) generating QnA pairs, (b) fine tuning Large Language Models (LLMs) on QnA pairs, and (c) evaluating the LLM model outputs. RESULTS: A quit smoking program spanning 42 days of 2 to 3-minute conversations covering topics ranging from motivations to quit, setting a quit date, choosing FDA-approved cessation medications, coping with triggers, and recovering from lapses/relapses. In a pilot randomized trial with 96% three-month outcome data retention, QuitBot demonstrated high user engagement and promising cessation rates compared to the National Cancer Institute's SmokefreeTXT (SFT) text messaging program-particularly among those who viewed all 42 days of program content: 30-day complete-case, point prevalence abstinence (PPA) rates at three-month follow-up were 63% (39/62) for QuitBot vs. 38% (45/117) for SFT (OR = 2.58; 95% CI: 1.34, 4.99; P =.005). However, Facebook Messenger (FM) intermittently blocked participants' access to QuitBot so we transitioned from FM to a standalone smartphone app as the communication channel. Participants' frustration with QuitBot's inability to answer their open-ended questions lead to us develop a core conversational feature enabling users to ask open-ended questions about quitting cigarette smoking and for the QuitBot to respond with accurate and professional answers. To support this functionality, we developed a library of 11,000 QnA pairs on topics associated with quitting cigarette smoking. Model testing results showed that Microsoft's Azure-based QnA maker effectively handled questions that matched our library of 11,000 QnA pairs. A fine-tuned, contextualized GPT3.5 responds to questions that are not within our library of QnA pairs. CONCLUSIONS: The development process yielded the first LLM-based quit smoking program delivered as a conversational chatbot. Iterative testing led to significant enhancements, including improvements to the delivery channel. A pivotal addition was the inclusion of a core LLM-supported conversational feature allowing users to ask open-ended questions. CLINICALTRIAL: ClinicalTrials.gov Identifier, NCT03585231.

Do Smartphone Apps Impact Long-Term Smoking Cessation for Sexual and Gender Minority Adults? Exploratory Results from a 2-Arm Randomized Trial Comparing Acceptance and Commitment Therapy with Standard US Clinical Practice Guidelines.

Sexual and gender minority (SGM) adults face unique challenges in accessing smoking cessation care due to stigma tied to their identities and smoking. While cessation apps show promise in the general population, their efficacy for SGM adults is unclear. This study utilized data from a randomized trial to compare two cessation apps, iCanQuit (Acceptance and Commitment Therapy-based) and QuitGuide (US Clinical Practice Guidelines-based) among 403 SGM adults. The primary outcome was self-reported complete-case 30-day abstinence from cigarette smoking at 12 months. Mediation analyses explored whether interventions operated through acceptance of cues to smoke and app engagement. At 12 months, quit rates did not differ between arms (26% iCanQuit vs. 22% QuitGuide, OR = 1.22; 95% CI: 0.74 to 2.00, p = .43). iCanQuit positively impacted cessation via acceptance of cues to smoke (indirect effect = 0.23; 95% CI: 0.06 to 0.50, p < .001) and demonstrated higher engagement (no. logins, 28.4 vs. 12.1; p < .001) and satisfaction (91% vs. 75%, OR = 4.18; 95% CI: 2.12 to 8.25, p < .001) than QuitGuide. Although quit rates did not differ between arms, acceptance of cues to smoke seemed to play a crucial role in helping SGM adults quit smoking. Future interventions should consider promoting acceptance of cues to smoke in this population.

The importance of community-specific survey data in understanding behavioral and social drivers of COVID-19 vaccination: Lessons learned from urban neighborhoods in four United States cities.

This descriptive study examined patterns and trends in coronavirus (COVID-19) vaccination rates and drivers among people living, working, or socializing in urban neighborhoods of predominantly Black and Hispanic communities and compared them with the results of two national surveys. Data for these communities came from a routine survey conducted as part of the Equity-first Vaccination Initiative (EVI) in urban neighborhoods within four United States (U.S.) cities during four phases of the pandemic between July 2021 and April 2022. Our sample included 5,970 responses, which were weighted to account for design effects and compositional differences among surveyed people across the four periods. We wanted to compare the results from the EVI survey to nationally representative surveys, therefore, we did not demographically weight the sample to look like the national surveys. As a result, the EVI survey included larger proportions of people identifying with non-white racial and ethnic groups than those groups' proportions of the national population per the last U.S. Census (African American or Black: 49.8% vs. 13.7%, Hispanic or Latino/Latinx 36.5% vs. 18.9%, respectively). More EVI respondents reported concern about vaccines and fewer reported trust in COVID-19 information key messengers than national averages. The EVI survey found variation in the proportions as well as the magnitude and directionality of increases or decreases in beliefs about vaccination safety and effectiveness, the influence of religious beliefs, and intentions to get vaccinated. These differences highlight the granular insight that community-specific data can help better tailor interventions to communities disproportionately impacted by disease.

Do medications increase the efficacy of digital interventions for smoking cessation? Secondary results from the iCanQuit randomized trial.

BACKGROUND AND AIMS: iCanQuit is a smartphone application (app) proven efficacious for smoking cessation in a Phase III randomized controlled trial (RCT). This study aimed to measure whether medications approved by the US Food and Drug Administration (FDA) for smoking cessation would further enhance the efficacy of iCanQuit, relative to its parent trial comparator-the National Cancer Institute's (NCI's) QuitGuide app. DESIGN: Secondary analysis of the entire parent trial sample of a two-group (iCanQuit and QuitGuide), stratified, doubled-blind RCT. SETTING: United States. PARTICIPANTS: Participants who reported using an FDA-approved cessation medication on their own (n = 619) and those who reported no use of cessation medications (n = 1469). INTERVENTIONS: Participants were randomized to receive iCanQuit app or NCI's QuitGuide app. MEASUREMENTS: Use of FDA-approved medications was measured at 3 months post-randomization. Smoking cessation outcomes were measured at 3, 6 and 12 months. The primary outcome was 12-month self-reported 30-day point prevalence abstinence (PPA). FINDINGS: The data retention rate at the 12-month follow-up was 94.0%. Participants were aged 38.5 years, 71.0% female, 36.6% minority race/ethnicity, 40.6% high school or less education, residing in all 50 US States and smoking 19.2 cigarettes/day. The 29.6% of all participants who used medications were more likely to choose nicotine replacement therapy (NRT; 78.8%) than other cessation medications (i.e. varenicline or bupropion; 18.3 and 10.5%, respectively) and use did not differ by app treatment assignment (all P > 0.05). There was a significant (P = 0.049) interaction between medication use and app treatment assignment on PPA. Specifically, 12-month quit rates were 34% for iCanQuit versus 20% for QuitGuide [odds ratio (OR) = 2.36, 95% confidence interval (CI) = 1.59, 3.49] among participants reporting any medication use, whereas among participants reporting no medication use, quit rates were 28% for iCanQuit versus 22% for QuitGuide (OR = 1.41, 95% CI = 1.09, 1.82). Results were stronger for those using only NRT: 40% quit rates for iCanQuit versus 18% quit rates for QuitGuide (OR = 3.57, 95% CI = 2.20, 5.79). CONCLUSIONS: The iCanQuit smartphone app for smoking cessation was more efficacious than the QuitGuide smartphone app, regardless of whether participants used medications to aid cessation. Smoking cessation medications, especially nicotine replacement therapy, might enhance the efficacy of the iCanQuit app.

Relative Efficacy of an Acceptance and Commitment Therapy-Based Smartphone App with a Standard US Clinical Practice Guidelines-Based App for Smoking Cessation in Dual Users of Combustible and Electronic Cigarettes: Secondary Findings from a Randomized Trial.

BACKGROUND: While smartphone apps for smoking cessation have shown promise for combustible cigarette smoking cessation, their efficacy in helping dual users of combustible and electronic cigarettes (e-cigarettes) to quit cigarettes remains unknown. This study utilized data from a randomized trial to determine if an Acceptance and Commitment Therapy (ACT)-based app (iCanQuit) was more efficacious than a US Clinical Practice Guidelines-based app (QuitGuide) for combustible cigarette smoking cessation among 575 dual users. METHODS: The primary cessation outcome was self-reported, complete-case 30-day abstinence from combustible cigarettes at 12 months. Logistic regression assessed the interaction between dual use and treatment arm on the primary outcome in the full trial sample (N = 2,415). We then compared the primary outcome between arms among dual users (iCanQuit: n = 297; QuitGuide: n = 178). Mediation analyses were conducted to explore mechanisms of action of the intervention: acceptance of cues to smoke and app engagement. Results: There was an interaction between dual use of combustible and e-cigarettes and treatment arm on the primary outcome (p = 0.001). Among dual users, 12-month abstinence from cigarettes did not differ between arms (23% for iCanQuit vs. 27% for QuitGuide, p = 0.40). Mediation analysis revealed a significant positive indirect effect of the iCanQuit app on 12-month abstinence from cigarettes through acceptance of emotions that cue smoking (p = 0.004). CONCLUSIONS: Findings from this study of dual users of combustible and e-cigarettes showed no evidence of a difference in quit rates between arms. Acceptance of emotions that cue smoking is a potential mechanism contributing to cigarette smoking abstinence among dual users.

Use of e-Cigarettes in Cigarette Smoking Cessation: Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Many adults use e-cigarettes to help them quit cigarette smoking. However, the impact of self-selected use of e-cigarettes on cigarette smoking cessation, particularly when concurrently receiving app-based behavioral interventions, remains unexplored. OBJECTIVE: This study used data from a randomized trial of 2 smartphone apps to compare 12-month cigarette smoking cessation rates between participants who used e-cigarettes on their own (ie, adopters: n=465) versus those who did not (ie, nonadopters: n=1097). METHODS: The study population included all participants who did not use e-cigarettes at baseline. "Adopters" were those who self-reported the use of e-cigarettes at either 3- or 6-month follow-ups. "Nonadopters" were those who self-reported no use of e-cigarettes at either follow-up time point. The primary cessation outcome was self-reported, complete-case, 30-day point prevalence abstinence from cigarette smoking at 12 months. Secondary outcomes were missing-as-smoking and multiple imputation analyses of the primary outcome, prolonged abstinence, and cessation of all nicotine and tobacco products at 12 months. In logistic regression models, we first examined the potential interaction between e-cigarette use and treatment arm (iCanQuit vs QuitGuide) on the primary cessation outcome. Subsequently, we compared 12-month cigarette smoking cessation rates between adopters and nonadopters separately for each app. RESULTS: There was suggestive evidence for an interaction between e-cigarette use and treatment arm on cessation (P=.05). In the iCanQuit arm, 12-month cigarette smoking cessation rates were significantly lower among e-cigarette adopters compared with nonadopters (41/193, 21.2% vs 184/527, 34.9%; P=.003; odds ratio 0.55, 95% CI 0.37-0.81). In contrast, in the QuitGuide arm, 12-month cigarette smoking cessation rates did not differ between adopters and nonadopters (46/246, 18.7% vs 104/522, 19.9%; P=.64; odds ratio 0.91, 95% CI 0.62-1.35). CONCLUSIONS: The use of e-cigarettes while concurrently receiving an app-based smoking cessation intervention was associated with either a lower or an unimproved likelihood of quitting cigarette smoking compared to no use. Future behavioral treatments for cigarette smoking cessation should consider including information on the potential consequences of e-cigarette use. TRIAL REGISTRATION: ClinicalTrials.gov NCT02724462; https://clinicaltrials.gov/study/NCT02724462.

Efficacy of smartphone applications to help cancer patients quit smoking: Protocol of the Quit2Heal randomized controlled trial.

Cigarette smoking is highly prevalent among cancer patients in the United States (US), with up to half of cancer patients smoking at the time of their initial cancer diagnosis. However, evidence-based cessation programs are rarely implemented in oncology care, and smoking is not consistently treated in cancer treatment settings. Consequently, there is an urgent need for accessible and efficacious cessation treatments that are uniquely tailored to the needs of cancer patients. Here we describe the design and implementation of a randomized controlled trial (RCT) testing the efficacy of a smartphone app (Quit2Heal) versus a US Clinical Practice Guidelines-based app (QuitGuide) for smoking cessation among a planned sample of 422 cancer patients. Quit2Heal is designed to address cancer-related shame, stigma, depression, anxiety, and knowledge about the consequences of smoking/quitting. Quit2Heal is based on the principles of Acceptance and Commitment Therapy, a behavioral therapy that teaches skills for accepting cravings to smoke without smoking, values-driven motivation to quit, and preventing relapse. The primary aim of the RCT is to determine whether Quit2Heal has significantly higher self-reported 30-day point prevalence abstinence at 12 months relative to QuitGuide. The trial will also determine whether Quit2Heal's effect on cessation is (1) mediated by improvements in cancer-related shame, stigma, depression, anxiety, and knowledge about the consequences of smoking/quitting; and (2) moderated by baseline factors (e.g., cancer type, stage, time since diagnosis). If successful, Quit2Heal will offer a more efficacious, broadly scalable smoking cessation treatment that could be implemented alongside existing oncology care, thereby improving cancer outcomes.

Telehealth acceptance and commitment therapy for weight loss: Protocol of the WeLNES full scale randomized controlled trial.

Behavioral interventions delivered via one-on-one telephone coaching (hereafter referred to as telehealth) for weight loss have had great population-level reach but to date limited efficacy. Acceptance and Commitment Therapy (ACT) has promise to improve behavioral weight loss treatment efficacy by addressing the fundamental challenges of weight loss and maintenance: overeating in response to internal (e.g., stress) and external (e.g., high calorie foods) cues. Here we describe the Weight Loss, Nutrition, and Exercise Study (WeLNES) randomized controlled trial that is testing the efficacy of an ACT-based telehealth coaching intervention for weight loss in comparison to a Standard Behavioral Therapy (SBT)-based telehealth coaching intervention. A total of 398 adults with overweight or obesity are being recruited and randomized to either ACT or SBT telehealth coaching. Participants in both arms are offered twenty-five telehealth coaching sessions in year one and nine booster sessions in year two. All participants receive a Bluetooth-enabled scale to self-monitor weight and a Fitbit Inspire + Fitbit app for tracking diet and physical activity. The primary aim is to determine whether a greater proportion of ACT participants will achieve a clinically significant weight loss of ≥10% compared with SBT participants at 12-months. Secondary outcomes include change in weight from baseline to 6, 12, and 24-months. Whether the effect of ACT on weight loss is mediated by ACT processes and is moderated by baseline factors will also be examined. If ACT proves efficacious, ACT telehealth coaching will offer an effective, broadly scalable weight loss treatment-thereby making a high public health impact.

Acceptance and Commitment Therapy-Based Smartphone Applications for Cessation of Tobacco Use among Adults with High Nicotine Dependence: Results from the iCanQuit Randomized Trial.

Background: With 1 in 2 adult tobacco users being highly dependent on nicotine, population-based interventions specifically designed for this group are urgently needed. This study used data from a randomized trial to evaluate whether (1) Acceptance and Commitment Therapy (ACT) delivered via a smartphone application (iCanQuit) would be more efficacious for cessation of nicotine-containing tobacco products than the US Clinical Practice Guidelines (USCPG)-based application (QuitGuide) among highly nicotine-dependent adults, (2) the effect of treatment on cessation was mediated by increases in acceptance of cravings to smoke, and (3) treatment utilization and satisfaction differed by arm. Methods: A total of 1452 highly nicotine-dependent adults received the iCanQuit or QuitGuide application for 12-months. Cessation outcomes were self-reported complete-case 30-day abstinence of nicotine-containing tobacco products (e.g., combustible cigarettes, e-cigarettes, chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, and kreteks) at 3, 6, and 12-month post-randomization timepoints, missing-as-smoking, and multiple imputation analyses. Acceptance of cues to smoke and satisfaction with the applications was also reported. Results: Participants who received iCanQuit were significantly more likely to report 30-day abstinence of nicotine-containing tobacco products than those who received QuitGuide at 12-months (24% vs. 17%; OR = 1.47 95% CI: 1.11, 1.95). iCanQuit participants utilized their application more frequently and reported greater satisfaction than those who received QuitGuide. Increases in participants' acceptance of cues to smoke mediated the intervention effect on cessation of nicotine-containing tobacco products. Conclusions: Among nicotine-dependent adults, an application-delivered ACT-based intervention was more engaging and efficacious than a USCPG-based intervention for cessation of nicotine-containing tobacco products.

Efficacy of Web-Delivered Acceptance and Commitment Therapy (ACT) for Helping Black Adults Quit Smoking.

BACKGROUND: Digital smoking cessation interventions may reduce racial disparities in cessation because they are low cost, scalable, and can provide support at any place or time. Despite their promise, whether Black adults engage with and benefit from these tools is largely unknown. In a secondary analysis of a randomized trial, we explored the efficacy of an acceptance and commitment therapy (ACT)-based website (WebQuit) for smoking cessation compared to a US clinical practice guidelines-based website (Smokefree.gov) among Black adults. METHODS: A total of 316 Black adult smokers were enrolled in the trial between May 2017 and September 2018 and received access to WebQuit or Smokefree for 12 months. Participants self-reported on 30-day and 7-day abstinence from cigarette smoking at 3, 6, and 12-months. Treatment engagement was objectively measured and compared between arms. Participants also reported on their willingness to accept cues to smoke without smoking. RESULTS: WebQuit versus Smokefree participants engaged more with their website (higher number of logins, Incidence Rate Ratio (IRR) = 2.21; 95% CI: 1.70, 2.89). Complete-case 30-day point prevalence abstinence (PPA) at 12-months was 34% for WebQuit vs. 29% for Smokefree (OR = 1.22 95% CI: 0.73, 2.04). Increases in participants' willingness to accept cues to smoke mediated the intervention effect on abstinence from cigarette smoking at 12 months. CONCLUSIONS: This study addressed the lack of research on the utilization and efficacy of digital interventions for helping Black adults quit smoking. WebQuit participants engaged more with their website and quit smoking at a somewhat higher rate relative to Smokefree participants, albeit nonsignificant. Findings suggest high acceptability of ACT-based digital interventions to enable Black adult smokers to engage and sustain behavior changes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01812278.

Can a smartphone application help Hispanic/Latinx adults quit smoking? A randomized trial secondary analysis.

Introduction: There are no known efficacious digital smoking cessation interventions for Hispanic/Latinx adults who smoke. This study is a secondary analysis using data from a randomized trial to evaluate whether Acceptance and Commitment Therapy (ACT) delivered via a smartphone app (iCanQuit) would be more efficacious for smoking cessation than the US Clinical Practice (USCPG)-based app (QuitGuide) in a sample of Hispanic/Latinx participants. Methods: A total of 210 Hispanic/Latinx adults who smoke were randomized to receive the iCanQuit or QuitGuide app for 12-months. Participants self-reported on 30-day abstinence from cigarette smoking at the 3-month, 6-month, and 12-month follow-ups; 7-day abstinence at all follow-ups; abstinence from other nicotine/tobacco products at 12-months; and continuous prolonged abstinence from 3 to 12-months. Participants also reported on their willingness to accept cues to smoke without smoking and satisfaction with their apps. Results: A total of 176 (84%) participants reported on study outcomes at the 12-month follow-up. Compared to QuitGuide participants, iCanQuit participants were significantly more likely to report 30-day abstinence from cigarette smoking at 12-months (34% iCanQuit, 20% QuitGuide; p=0.026). iCanQuit participants utilized their app more frequently and reported greater satisfaction with their assigned app than those who received the QuitGuide app. Increases in participants' willingness to accept cues to smoke mediated the intervention effect on abstinence from cigarette smoking at 12-months. Conclusions: Acceptance and Commitment Therapy-delivered via a smartphone app may be efficacious for helping Hispanic/Latinx adults abstain from cigarette smoking. Replication in a fully powered randomized trial that focuses on an independent sample of Hispanic/Latinx adults is now needed.

Web-delivered Acceptance and Commitment Therapy (ACT) for smoking cessation: Is it engaging and efficacious for US Hispanic/Latinx adult smokers?

Hispanic/Latinx adult smokers in the United States (US) face barriers to receiving and utilizing evidenced-based cessation treatments compared with other racial/ethnic groups. The lack of efficacious and accessible smoking cessation treatments for this population further contributes to such smoking disparities. In a secondary analysis, we explored the efficacy of an Acceptance and Commitment Therapy (ACT)-based website (WebQuit.org) versus a US Clinical Practice Guidelines (USCPG)-based website (Smokefree.gov) for smoking cessation in a subset of Hispanic/Latinx adult participants enrolled in the WebQuit trial. Of the 2,637 participants who were randomized in the parent trial, 222 were Hispanic/Latinx (n = 101 in WebQuit, n = 121 in Smokefree). Smoking cessation outcomes were measured at 3, 6, and 12-months. The primary outcome was self-reported complete-case 30-day point prevalence abstinence (PPA) at 12-months. Treatment engagement and satisfaction, change in acceptance of urges to smoke, and commitment to quitting smoking were compared across conditions. Retention rate was 88% at 12-months. WebQuit participants had higher odds of smoking cessation compared to Smokefree participants at 12-months (40% vs. 25%; OR = 1.93 95% CI: 1.04, 3.59). Findings were similar using multiple imputation. WebQuit participants engaged more with the website than Smokefree participants through multiple indicators of engagement, including spending more time using the website (IRR = 2.32; 95% CI: 1.68, 3.20). Although WebQuit participants engaged more with the website than Smokefree participants, there was no evidence that differences in quit rates were mediated by engagement level. This study provides initial empirical evidence that digital interventions may be efficacious for helping Hispanic/Latinx adults quit smoking.

Efficacy of smartphone applications for smoking cessation in heavy-drinking adults: Secondary analysis of the iCanQuit randomized trial.

INTRODUCTION: Efficacious smoking cessation treatments are needed for heavy-drinking adults who often have difficulty quitting smoking. In a secondary analysis of a parent randomized controlled trial, we explored the efficacy of an Acceptance and Commitment Therapy (ACT)-based smartphone application (iCanQuit) versus a US Clinical Practice Guidelines (USCPG)-based smartphone application (QuitGuide) for smoking cessation among heavy-drinking participants (4 + drinks/day for women; 5 + drinks/day for men). METHODS: Participants were randomized to receive iCanQuit (n = 188) or QuitGuide (n = 160) for 12-months. Smoking cessation outcomes were measured at 3, 6 and 12-months. The primary outcome was self-reported complete-case 30-day point prevalence abstinence (PPA) at 12-months. Secondary outcomes were 7-day PPA at all timepoints; prolonged abstinence; and cessation of all nicotine-containing products at 12-months. Multiple imputation and missing-as-smoking analyses were also conducted. Exploratory outcomes were cessation of both smoking and heavy drinking and change in alcohol use (drinks/day) at 12-months. Treatment engagement and satisfaction and change in ACT-based processes were compared between arms. RESULTS: Retention rate was 85% at 12-months and did not differ by arm. At 12-months, iCanQuit participants had nearly double the odds of smoking cessation compared to QuitGuide (complete-case 30-day PPA = 24% vs. 15%; OR = 1.87 95% CI: 1.03, 3.42). Findings were similar for the multiple imputation and missing-as-smoking outcomes at 12-months. Combined cessation of smoking and heavy drinking, and alcohol use at 12-months did not differ by arm. iCanQuit was significantly more engaging and satisfying than QuitGuide. Increased acceptance of thoughts about smoking mediated the effect of treatment on cessation of heavy drinking at 12-months. CONCLUSIONS: The iCanQuit smartphone application was more efficacious and engaging for smoking cessation among heavy-drinking adults than a USCPG-based smartphone application.

Older adults who smoke: Do they engage with and benefit from web-based smoking cessation interventions?

Quitting smoking at any age increases life expectancy, but older adults face barriers to receiving cessation services. Despite the promise of web-based smoking cessation interventions to help address access barriers, whether older adults who participate in smoking cessation programs engage with and benefit from these tools at the same rate as younger adults remains unknown. In this secondary analysis, we compared engagement and satisfaction with two web-based smoking cessation interventions and quit rates between older, middle-aged, and young adults in the United States enrolled in the WebQuit trial between March 2014 and August 2015. Participants were divided into age groups: older (60 years and older, n = 439/2637), middle-aged (40-59 years, n = 1308/2637), and young adults (18-39 years, n = 890/2637). Treatment engagement and satisfaction, and 12-month quit rates (self-reported complete-case 30-day PPA and missing-as-smoking) were compared between groups. Older adults engaged more with the websites than young adults through multiple indicators of intervention engagement (i.e., number of sessions, unique days of use, and time spent on the site), and older adults spent more time on the site per session than their counterparts. Satisfaction with websites was high (81%) and non-differential between groups. Older and middle-aged adults quit smoking at a similar rate as younger adults (24%, 24%, 27%, respectively, p = 0.905). Older and middle-aged adults who participated in a web-delivered smoking cessation intervention engaged more with the intervention than their younger counterparts and they quit smoking at a similar rate, thereby demonstrating high acceptability and potential of digital interventions to help older adults quit smoking. Trial registration:ClinicalTrials.gov Identifier: NCT1166334.

Efficacy of an acceptance and commitment therapy-based smartphone application for helping rural populations quit smoking: Results from the iCanQuit randomized trial.

Limited access to evidence-based smoking cessation interventions among rural populations contributes to high rates of cigarette smoking and poor cessation outcomes. Yet, accessible digital interventions for cessation focusing on rural populations are lacking. In a secondary analysis, we determined the acceptability and efficacy of an Acceptance and Commitment Therapy (ACT)-based smartphone application (iCanQuit) relative to a U.S. Clinical Practice Guidelines (USCPG)-based smartphone application (QuitGuide) for smoking cessation among rural participants enrolled in the two-arm randomized iCanQuit trial. Participants were enrolled between May 2017 and September 2018 and randomized to either receive iCanQuit or QuitGuide for 12-months. Rural residence was determined by sub-county level Rural-Urban Commuting Area codes. A total of 550 rural participants were recruited from 43 U.S. states. Self-reported complete-case 30-day point-prevalence abstinence was 15% (33/226) for iCanQuit vs. 9% (22/253) for QuitGuide at 3-months (OR = 1.83; 95% CI: 1.03, 3.25) and 29% (66/231) for iCanQuit vs. 25% (64/288) for QuitGuide at 12-months (OR = 1.19 95% CI: 0.80, 1.79). Retention rate was 89% at 12-months and did not differ by arm. iCanQuit vs. QuitGuide participants were significantly more engaged and satisfied with the iCanQuit application. Increased acceptance of internal cues to smoke mediated the effect of treatment on cessation. Findings suggest that iCanQuit had significantly higher short-term quit rates, descriptively higher long-term quit rates, and operated through its hypothesized mechanisms of action relative to QuitGuide. Future larger studies are needed to further evaluate the efficacy of and methods for disseminating the iCanQuit application for smoking cessation among U.S. rural adults nationwide. Trial registrationClinicalTrials.gov Identifier: NCT02724462.

Full-scale Randomized Trial Comparing Acceptance and Commitment Therapy Telephone-Delivered Coaching With Standard Telephone-Delivered Coaching Among Medicare/Uninsured Quitline Callers.

INTRODUCTION: The aim of this study was to compare Acceptance and Commitment Therapy (ACT) telephone-delivered coaching with standard quitline (QL) telephone-delivered coaching. METHODS: Medicare/uninsured adults (analyzable sample N = 1170) who smoked at least 10 cigarettes per day were recruited from Optum, a major US provider of QL services, in a two-arm stratified double-blind randomized trial with main outcome of self-reported missing = smoking 30-day point prevalence abstinence (PPA) at the 12-month follow-up. Participants were mean (SD) age 47.4 (12.7), 61% female, and 72% white race. Five sessions of telephone-delivered ACT or QL interventions were offered. Both arms included combined nicotine patch (4 weeks) and gum or lozenge (2 weeks). RESULTS: The 12-month follow-up data retention rate was 67.8%. ACT participants reported their treatment was more useful for quitting smoking (92.0% for ACT vs. 82.3% for QL; odds ratio [OR] = 2.48; 95% confidence interval [CI]: 1.53 to 4.00). Both arms had similar 12-month cessation outcomes (missing = smoking 30-day PPA: 24.6% for ACT vs. 28.8% for QL; OR =.81; 95% CI: 0.62 to 1.05) and the ACT arm trended toward greater reductions in number cigarettes smoked per day (-5.6 for ACT vs. -1.7 QL, among smokers; p = .075). CONCLUSIONS: ACT telephone-delivered coaching was more satisfying, engaging, and was as effective as standard QL telephone-delivered coaching. ACT may help those who fail to quit after standard coaching or who choose not to use nicotine replacement therapy. IMPLICATIONS: In a sample of Medicare and uninsured QL callers, a large randomized trial with long-term follow-up showed that ACT) telephone-delivered coaching was more satisfying, engaging, and was as effective as standard QL telephone-delivered coaching-which has followed the same behavior change approach since the 1990s. This newer model of coaching might be a welcome addition to QL services.

Efficacy and utilization of smartphone applications for smoking cessation among low-income adults: Secondary analysis of the iCanQuit randomized trial.

INTRODUCTION: Evidence of digital interventions that are efficacious among low-income populations is scarce. In a secondary analysis, we determined the efficacy and utilization of an Acceptance and Commitment Therapy (ACT)-based smartphone application (iCanQuit) versus a U.S. Clinical Practice Guidelines (USCPG)-based smartphone application (QuitGuide) for smoking cessation in low-income adults enrolled in the iCanQuit randomized trial. METHODS: Participants were randomized to receive iCanQuit (n = 437) or QuitGuide (n = 460) for 12-months. Consistent with the main trial, the primary outcome was self-reported complete-case 30-day point prevalence abstinence (PPA) at 12-months. Secondary outcomes were 7-day PPA, missing-as-smoking and multiple imputation, prolonged abstinence, and cessation of all tobacco products at 12-months. Outcome data retention, utilization, and change in ACT-based processes were compared across arms. RESULTS: Participants were recruited from 48 U.S. states. Retention rate was 88% at 12-months and did not differ by arm. At 12-months, iCanQuit was 1.46 times more efficacious than QuitGuide for smoking cessation (27% vs. 20%; OR=1.46 95% CI: 1.04, 2.06). Findings were similar for missing-as-smoking imputation (23% vs. 18%; OR=1.41 95% CI: 1.01, 1.97) and multiple imputation at 12-months (27% vs. 20%; OR=1.51 95% CI: 1.07, 2.14). Treatment utilization was significantly higher among iCanQuit than QuitGuide participants. Increased acceptance of cues to smoke mediated the effect of treatment on cessation. CONCLUSIONS: The iCanQuit smartphone application was more efficacious and engaging for smoking cessation among low-income adults than a USCPG-based smartphone application. A nationwide dissemination trial of iCanQuit is warranted to determine whether iCanQuit may alleviate cessation-related disparities among low-income adults.

Efficacy and Utilization of Smartphone Applications for Smoking Cessation Among American Indians and Alaska Natives: Results From the iCanQuit Trial.

INTRODUCTION: There is tremendous need for efficacious and accessible interventions for smoking cessation among American Indians and Alaska Natives. We tested the efficacy of an Acceptance and Commitment Therapy (ACT)-based smartphone application (iCanQuit) versus US Clinical Practice Guidelines-based smartphone application (QuitGuide) for smoking cessation among American Indians and Alaska Natives. AIMS AND METHODS: We compared cessation, changes in ACT-based processes, engagement and satisfaction between American Indian and Alaska Native iCanQuit (n = 89) and QuitGuide (n = 80) participants enrolled in the iCanQuit trial. The primary outcome was self-reported, complete-case, 30-day point-prevalence abstinence. Follow-up timepoints were 12, 6, and 3 months. RESULTS: Randomized American Indians and Alaska Natives from 31 US states (70% urban, 30% rural, with 25% of participants residing on tribal land). The outcome data retention rates were 93%, 92%, and 90% at the 12-, 6-, and 3-month follow-ups, respectively, with no differential retention between arms. The 30-day point-prevalence abstinence for iCanQuit versus QuitGuide was 30% versus 18% at 12 months (odds ratio [OR] = 1.96; 95% confidence interval [CI]: 0.90 to 4.26) 25% versus 11% at 6 months (OR = 2.62; 95% CI: 1.06 to 6.45), and 15% versus 6% at 3 months (OR = 2.93; 95% CI: 0.90 to 9.59). Increases in acceptance of internal cues to smoke mediated the effect of treatment on smoking cessation at 12 months. iCanQuit arm participants were also significantly more engaged and satisfied with their assigned application. CONCLUSIONS: In a nationwide sample with high data retention and participant engagement, this is the first study to show that a digital intervention may be efficacious for helping American Indians and Alaska Natives quit smoking. IMPLICATIONS: This is the first study to provide evidence of an efficacious, accessible, and engaging treatment for helping American Indians and Alaska Natives quit smoking. Compared to a US Clinical Practice Guidelines-based smartphone application (QuitGuide), an ACT-based smartphone application (iCanQuit) was more efficacious, engaging, and satisfactory among American Indians and Alaska Natives nationwide. Our results will inform the tailoring of the iCanQuit smartphone application for American Indian and Alaska Native tribal communities and organizations with potential for broad dissemination and high impact.

MIRROR-TCM: Multisite Replication of a Randomized Controlled Trial - Transitional Care Model.

In the U.S., older adults hospitalized with acute episodes of chronic conditions often are rehospitalized within 30 days of discharge. Numerous studies reveal that poor management of the complex needs of this population remains the norm. METHODS: This prospective, intent-to-treat, randomized controlled trial (RCT) will assess the effects of replicating the rigorously studied Transitional Care Model (TCM) in four U.S. healthcare systems. The TCM is an advanced practice registered nurse led, team-based, care management intervention that supports older adults throughout vulnerable care episodes that span hospital to home. This RCT will compare health and economic outcomes demonstrated by at-risk older adults hospitalized with heart failure, chronic obstructive pulmonary disease or pneumonia randomized to receive usual discharge planning (control group, N = 800) to those observed by a similar group of older adults randomized to receive the TCM protocol (N = 800). The primary outcome is number of rehospitalizations at 12 months post-discharge, with secondary resource use outcomes measured at multiple intervals. Patient experience with care, health and quality of life outcomes will be assessed at 90 days post-discharge. DISCUSSION: Based on health and economic benefits demonstrated in multiple NIH funded RCTs, the study team hypothesizes that the intervention group, both within and across participating health systems, will have decreased acute care resource use and costs at 12 months and better ratings of the care experience and health and quality of life through 90 days post-discharge compared to the control group. The impact of COVID-19 on implementation of this study also is discussed.

Efficacy and utilization of an acceptance and commitment therapy-based smartphone application for smoking cessation among Black adults: secondary analysis of the iCanQuit randomized trial.

BACKGROUND AND AIMS: Black adults who smoke are less likely to seek treatment and to succeed in quitting compared with other racial groups. The lack of efficacious and engaging trials for smoking cessation further contributes to this disparity. This study explored whether an acceptance and commitment therapy (ACT)-based smartphone application (iCanQuit) was more efficacious for smoking cessation than a United States Clinical Practice Guidelines (USCPG)-based smartphone application (QuitGuide) among Black adults. DESIGN: Secondary analysis of a two-arm randomized trial with 12-month follow-up. SETTING: United States (US). PARTICIPANTS: A total of 554 Black adults who smoke daily were recruited from 34 US states and enrolled between May 2017 and September 2018. INTERVENTIONS: Participants were randomized to receive iCanQuit (n = 274) or QuitGuide (n = 280) for 12 months. MEASUREMENTS: Smoking cessation outcomes were measured at 3, 6, and 12 months. The primary outcome was self-reported complete-case 30-day point prevalence abstinence (PPA) at 12 months. Secondary outcomes were 7-day PPA, missing-as-smoking imputation, multiple imputation, prolonged abstinence, and cessation of all tobacco products at 12 months. Study retention, treatment engagement, and change in ACT-based processes were also compared between arms. FINDINGS: Study retention was 89% at 12 months and did not differ by arm (P > 0.05). The complete-case 30-day PPA was 28% for iCanQuit versus 20% for QuitGuide at 12 months (odds ratio [OR] = 1.60; 95% confidence interval [CI] = 1.03, 2.46). Similar associations were observed for the missing-as-smoking imputation, although non-significant (25% iCanQuit vs 18% QuitGuide; OR = 1.50; 95% CI = 0.98, 2.30). iCanQuit vs QuitGuide participants were significantly more engaged with iCanQuit application as measured by the number of logins from baseline to 6 months (incidence rate ratio = 3.26; 95% CI = 2.58, 4.13). Increased acceptance of cues to smoke mediated the effect of treatment on cessation (indirect effect: OR = 0.20; 95% CI = 0.05, 0.29). CONCLUSIONS: Among Black adults, an acceptance and commitment therapy-based smartphone application appeared to be more efficacious and engaging for smoking cessation than the United States Clinical Practice Guidelines-based QuitGuide application.