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.

Direct Sub-Scarpal Lipectomy Combined With Liposuction in Abdominoplasty: An Analysis of Safety & Efficacy in 200 Consecutive Patients.

BACKGROUND: Abdominoplasty procedures continue to evolve as combining techniques such as suction-assisted lipectomy or direct sub-scarpal lipectomy have proven to be powerful adjuncts to achieve optimal aesthetic results. However, there is apprehension in combining techniques simultaneously given the potential to affect the vascularity of the abdominoplasty flap. OBJECTIVES: To assess the safety and efficacy of simultaneous direct sub-scarpal lipectomy combined with liposuction in abdominoplasty patients. METHODS: A 4-year retrospective review of consecutive abdominoplasties (n = 200) performed by a single surgeon was conducted. Liposuction of the abdominal flap and flanks was performed in all patients. After raising the abdominoplasty flap, undermining was performed to just beyond the xyphoid, lower rib margins superiorly, and to the anterior axillary line laterally. Fat deep to Scarpa's fascia was then removed by direct tangential excision in all zones of the abdominal flap. RESULTS: Average values included: Age, 42.19; BMI, 28.10 kg/m2; follow up, 7 months. Seroma occurred in 13 patients (6.5%), superficial wound dehiscence treated with local wound care in 16 patients (8%), hypertrophic scarring in 16 patients (8%), partial umbilical necrosis in one patient (0.5%), and partial umbilical epidermolysis in six patients (3%). No patients experienced major or minor full-thickness tissue loss. No patients needed reoperation. CONCLUSIONS: Simultaneous direct excision of sub-scarpal fat with liposuction of the abdomen and flanks does not appear to subject any zone of the abdominoplasty flap to increased risks of vascular compromise. No flap necroses were observed. The use of our technique is safe and may provide superior abdominoplasty results.

Emotional dysregulation among English-speaking Hispanic persons who smoke living in the United states.

Hispanic/Latinx (hereafter Hispanic) individuals in the United States (US) experience serious tobacco-related disparities and factors contributing to such disparities need to be adequately identified and clinically addressed. Emotion dysregulation is a key transdiagnostic relevant to smoking. The present cross-sectional investigation sought to test if emotion dysregulation was related to more severe problems during smoking quit attempts (e.g., irritability, weight gain), perceptions of difficulty about quitting, as well as negative and positive beliefs about smoking abstinence in a sample of English-speaking Hispanic adults residing in the US who smoke. Participants included 332 Hispanic adults who engaged in daily cigarette smoking (35.46 years old, 37 % identified as female). Emotion dysregulation was significantly related to more severe problems when quitting and perceived barriers for quitting, as well as negative beliefs about smoking abstinence. Additionally, emotion dysregulation was significantly and negatively related to positive outcomes about smoking abstinence. The amount of change in the various smoking criterion variables accounted for by emotion dysregulation was small (sr2 range: 0.028-0.085), but evident in adjusted models that accounted for a wide range of factors (e.g., depression, drug use severity). Overall, this investigation found consistent empirical evidence that individual differences in emotion dysregulation in Hispanic individuals were associated with several clinically significant smoking processes, suggesting this construct may represent an important factor involved in the maintenance and relapse of smoking among this ethnic population.

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.

Development and initial testing of mindful journey: a digital mindfulness-based intervention for promoting recovery from Substance use disorder.

BACKGROUND/OBJECTIVES: There is a great unmet need for accessible adjunctive interventions to promote long-term recovery from substance use disorder (SUD). This study aimed to iteratively develop and test the initial feasibility and acceptability of Mindful Journey, a novel digital mindfulness-based intervention for promoting recovery among individuals with SUD. PATIENTS/MATERIALS: Ten adults receiving outpatient treatment for SUD. METHODS: Phase 1 (n = 5) involved developing and testing a single introductory digital lesson. Phase 2 included a separate sample (n = 5) and involved testing all 15 digital lessons (each 30- to 45-minutes) over a 6-week period, while also receiving weekly brief phone coaching for motivational/technical support. RESULTS: Across both phases, quantitative ratings (rated on a 5-point scale) were all at or above a 4 (corresponding with 'agree') for key acceptability dimensions, such as usability, understandability, appeal of visual content, how engaging the content was, and helpfulness for recovery. Additionally, in both phases, qualitative feedback indicated that participants particularly appreciated the BOAT (Breath, Observe, Accept, Take a Moment) tool for breaking down mindfulness into steps. Qualitative feedback was used to iteratively refine the intervention. For example, based on feedback, we added a second core mindfulness tool, the SOAK (Stop, Observe, Appreciate, Keep Curious), and we added more example clients and group therapy videos. In Phase 2, 4 out of 5 participants completed all 15 lessons, providing initial evidence of feasibility. Participants reported that the phone coaching motivated them to use the app. The final version of Mindful Journey was a smartphone app with additional features, including brief on-the-go audio exercises and a library of mindfulness practices. Although, participants used these additional features infrequently. CONCLUSIONS: Based on promising initial findings, future acceptability and feasibility testing in a larger sample is warranted. Future versions might include push notifications to facilitate engagement in the additional app features.

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.

Personalized feedback intervention for individuals with low distress tolerance who smoke cigarettes: A randomized controlled trial of a digital intervention.

INTRODUCTION: Cigarette smoking remains the leading preventable cause of death and disability in the United States and frequently co-occurs with anxiety and depressive symptoms. A novel and integrative, theory-driven approach to address the heterogeneity of mood-related symptoms associated with cigarette use is to focus on transdiagnostic processes, such as distress tolerance, that underpin both mood-related symptoms and smoking behavior. The current study sought to develop and examine the feasibility, acceptability, and initial efficacy of a digitally delivered integrated personalized feedback intervention (PFI) that addresses smoking-distress tolerance relations. METHODS: Participants included 121 adults (71.1 % male; Mage = 29.33 years, SD = 7.52) who smoked cigarettes daily and reported low distress tolerance. The study randomized participants to the Active PFI (feedback on distress tolerance and smoking) or the Control PFI (feedback on smoking only). RESULTS: Results indicated feasibility and acceptability demonstrated by the ability to retain participants through the 1-month follow-up (98.2 % retention rate) and positive feedback from participants, including satisfaction regarding the Active PFI. The Active PFI (vs. Control PFI) was also a statistically significant predictor of change in motivation and intention to quit smoking and willingness to use adaptive coping strategies from baseline to 1-month follow-up. CONCLUSIONS: For individuals with low distress tolerance who smoke cigarettes, this study's findings suggest that the current intervention may be a first-step to aid in increasing motivation/intention to quit smoking and willingness to use adaptive coping strategies.

Pain Trajectories among U.S. Veterans During COVID-19.

Physical pain is highly prevalent among military veterans. As stress can impact pain, COVID-19-related stressors may have heightened pain among veterans. A prospective analysis of pain could advance understanding of how veterans fared during COVID-19 and lend knowledge of risk factors important beyond the pandemic. The present study employs growth mixture modeling with a sample of U.S. veterans high in pain (N = 1,230) followed from just before COVID-19 (February 2020) to 12 months later (February 2021; 81.7% retention). We explored heterogeneous pain trajectories as well as baseline and COVID-19-related predictors of pain. Results revealed 4 pain trajectory classes: 1) Chronic Pain (17.3% of the sample); 2) Decreasing Pain (57.2% of the sample); 3) Stable Mild Pain (19.8% of the sample); and 4) Increasing Pain (5.7% of the sample). Those with childhood trauma exposure were especially likely to report chronic pain. Female and racial/ethnic minority veterans were also relatively likely to fare poorly in pain. Loneliness was associated with subsequent pain among several classes. Most veterans in our sample fared better than expected in terms of pain. However, as those with childhood trauma and certain disadvantaged groups were less likely to fare well, we add to the important literature on disparities in pain. Clinicians should identify whether loneliness and other factors impacted pain during COVID-19 among their patients to inform ongoing, person-centered pain management approaches. PERSPECTIVE: This article presents pain trajectories and correlates of pain among a high-pain sample of U.S. veterans surveyed prior to and during COVID-19. Pain clinicians should screen for childhood trauma and remain vigilant in addressing health disparities.

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.

Cigarette Smoking and Depression Among U.S. Veterans: Longitudinal Associations With Posttraumatic Stress Disorder.

INTRODUCTION: Cigarette smoking and depression are associated with morbidity and mortality. Among veterans, approximately 22% are current smokers and 11%-15% have been diagnosed with depression. Although prior research suggests a strong association between smoking and depression among veterans, little research has examined trajectories of smoking and depressive symptoms and their correlates over time in this population. AIMS AND METHODS: Using parallel process growth curve modeling, we examined the longitudinal relationship between smoking and depression and tested whether posttraumatic stress disorder (PTSD) symptoms predict smoking and depression trajectories over 18 months (February 2020-August 2021). Veterans were recruited for an online, longitudinal study and responded to surveys across five-time points (baseline N = 1230; retention = 79.3%-83.3% across waves). RESULTS: Associations indicated that more frequent smoking at baseline was associated with steeper increases in depression symptom severity, and greater depression severity at baseline was associated with a less steep decrease in smoking frequency over time. PTSD was associated with less smoking at time 1 but more frequent smoking at times 3-5 as well as greater depression across all time points. CONCLUSIONS: Findings provide support that the growth trajectories of smoking and depression are linked, and PTSD symptoms are associated with these trajectories among veterans. Addressing these factors simultaneously in veteran treatment centers or through tobacco cessation efforts may be beneficial. IMPLICATIONS: This study offers strong evidence that the growth trajectories of smoking and depression are linked, and PTSD symptoms affect these trajectories among veterans, who represent a largely understudied population despite high rates of substance use and mental health problems. Results of this study strengthen the case for a more integrated treatment approach in which both smoking and mental health concerns are simultaneously addressed, which may yield more beneficial physical health and clinical outcomes for post-9/11 veterans.

Role of perceived discrimination and anxiety sensitivity in cigarette smoking among english-speaking latinx adults living in the United States.

OBJECTIVE: The Latinx/Hispanic (hereafter, Latinx) population in the United States (US) experiences significant tobacco-related health disparities. Extant work suggests social determinants of health (SDoH) such as perceived discrimination is an individual differences factor for cigarette smoking behavior among Latinx individuals who smoke cigarettes. Other research has suggested sensitivity to internal cues, referred to as anxiety sensitivity, is related to smoking among Latinx adults, but this work has not explored whether anxiety sensitivity may moderate the association between perceived discrimination and smoking behavior. METHOD: Therefore, the present investigation sought to explore the main and interactive association of perceived discrimination and anxiety sensitivity in relation to cigarettes smoked per day, severity of problems experienced when quitting, and perceived barriers for smoking cessation among 338 English-speaking Latinx individuals living in the US (Mage = 35.5 years; SD = 8.65; age range 18-61; 37.3% female) who smoke cigarettes. RESULTS: Results supported statistically significant main effects for perceived discrimination and anxiety sensitivity in relation to increased severity of problems experienced when quitting and perceived barriers for smoking cessation. These associations were evident after adjusting for a sociodemographic covariates. CONCLUSION: Overall, the present investigation suggests that both perceived discrimination and anxiety sensitivity are important constructs relevant to understanding smoking processes among Latinx adults who smoke cigarettes and should be integrated in theoretical models of smoking among this population.

Comparative effectiveness of mobile health smoking cessation approaches among underserved patients in primary care: Study protocol for the PROMOTE-UP trial.

INTRODUCTION: Tobacco smoking is the leading cause of preventable disease, disability, and premature death in the United States. Recent advances have led to two efficacious mobile health (mHealth) treatments for smoking cessation: iCanQuit, an Acceptance and Commitment Therapy-based behavioral treatment promoting cessation through accepting triggers and committing to values; and Motiv8, a contingency management intervention promoting smoking cessation with financial incentives via biochemically verified abstinence. This study will evaluate the comparative effectiveness of the Florida Quitline, iCanQuit alone, and iCanQuit+Motiv8 in a pragmatic trial among patients who smoke in underserved primary care settings. METHODS: The study will be an individually-randomized controlled trial with three arms (Florida Quitline, iCanQuit alone, iCanQuit+Motiv8 combined) conducted in multiple primary care practices affiliated with the OneFlorida+ Clinical Research Consortium. Adult patients who smoke will be randomized to one of the 3 study arms (n = 444/arm), stratified by healthcare setting (academic vs. community). The primary outcome will be 7-day point prevalence smoking abstinence at 6 months post-randomization. Secondary outcomes will be 12-month smoking abstinence, patient satisfaction with the interventions, and changes in patient quality of life and self-efficacy. The study will also assess how and for whom the interventions help sub-group patients in achieving smoking abstinence by measuring theory-derived factors that mediate smoking outcome-specific baseline moderators. CONCLUSIONS: Results from this study will provide evidence for the comparative effectiveness of mHealth smoking cessation interventions in healthcare settings. Use of mHealth interventions can make smoking cessation resources more equitably accessible and have far-reaching impact on community and population health. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05415761, Registered 13 June 2022.

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.

Can a Single Variable Predict Early Dropout From Digital Health Interventions? Comparison of Predictive Models From Two Large Randomized Trials.

BACKGROUND: A single generalizable metric that accurately predicts early dropout from digital health interventions has the potential to readily inform intervention targets and treatment augmentations that could boost retention and intervention outcomes. We recently identified a type of early dropout from digital health interventions for smoking cessation, specifically, users who logged in during the first week of the intervention and had little to no activity thereafter. These users also had a substantially lower smoking cessation rate with our iCanQuit smoking cessation app compared with users who used the app for longer periods. OBJECTIVE: This study aimed to explore whether log-in count data, using standard statistical methods, can precisely predict whether an individual will become an iCanQuit early dropout while validating the approach using other statistical methods and randomized trial data from 3 other digital interventions for smoking cessation (combined randomized N=4529). METHODS: Standard logistic regression models were used to predict early dropouts for individuals receiving the iCanQuit smoking cessation intervention app, the National Cancer Institute QuitGuide smoking cessation intervention app, the WebQuit.org smoking cessation intervention website, and the Smokefree.gov smoking cessation intervention website. The main predictors were the number of times a participant logged in per day during the first 7 days following randomization. The area under the curve (AUC) assessed the performance of the logistic regression models, which were compared with decision trees, support vector machine, and neural network models. We also examined whether 13 baseline variables that included a variety of demographics (eg, race and ethnicity, gender, and age) and smoking characteristics (eg, use of e-cigarettes and confidence in being smoke free) might improve this prediction. RESULTS: The AUC for each logistic regression model using only the first 7 days of log-in count variables was 0.94 (95% CI 0.90-0.97) for iCanQuit, 0.88 (95% CI 0.83-0.93) for QuitGuide, 0.85 (95% CI 0.80-0.88) for WebQuit.org, and 0.60 (95% CI 0.54-0.66) for Smokefree.gov. Replacing logistic regression models with more complex decision trees, support vector machines, or neural network models did not significantly increase the AUC, nor did including additional baseline variables as predictors. The sensitivity and specificity were generally good, and they were excellent for iCanQuit (ie, 0.91 and 0.85, respectively, at the 0.5 classification threshold). CONCLUSIONS: Logistic regression models using only the first 7 days of log-in count data were generally good at predicting early dropouts. These models performed well when using simple, automated, and readily available log-in count data, whereas including self-reported baseline variables did not improve the prediction. The results will inform the early identification of people at risk of early dropout from digital health interventions with the goal of intervening further by providing them with augmented treatments to increase their retention and, ultimately, their intervention outcomes.

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.

Management of a Gluteal Noninvoluting Hemangioma With Glue Embolization and Excision.

Noninvoluting congenital hemangiomas (NICHs) persist in a high-flow state into childhood and often require surgical excision. The inherent vascular nature of these tumors make effective surgical treatment challenging. Here we report on a patient that underwent intraoperative glue embolization and complete excision of a large gluteal NICH. Concurrent glue embolization followed by complete excision allows for decreased intraoperative blood loss and easier discrimination between the tumor and surrounding structures. Treating difficult vascular tumors with a multidisciplinary approach and subsequent intraoperative glue embolization with surgical excision allows for an effective, single-stage approach to NICHs.

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.