Examining Links Between Distinct Affective States and Tobacco Lapse During a Cessation Attempt Among African Americans: A Cohort Study.

BACKGROUND: Affect states are posited to play a pivotal role in addiction-related processes, including tobacco lapse (i.e., smoking during a quit attempt), and distinct affective states (e.g., joy vs. happiness) may differentially influence lapse likelihood. However, few studies have examined the influence of distinct affective states on tobacco lapse. PURPOSE: This study examines the influence of 23 distinct affect states on tobacco lapse among a sample of tobacco users attempting to quit. METHODS: Participants were 220 adults who identified as African American (50% female, ages 18-74). Ecological momentary assessment was used to assess affect and lapse in real-time. Between and within-person associations testing links between distinct affect states and lapse were examined with multilevel modeling for binary outcomes. RESULTS: After adjusting for previous time's lapse and for all other positive or negative affect items, results suggested that at the between-person level, joy was associated with lower odds of lapse, and at the within-person level, attentiveness was associated with lower odds of lapse. Results also suggested that at the between-person level, guilt and nervous were associated with higher odds of lapse, and at the within-person level, shame was associated with higher odds of lapse. CONCLUSIONS: The present study uses real-time, real-world data to demonstrate the role of distinct positive and negative affects on momentary tobacco lapse. This work helps elucidate specific affective experiences that facilitate or hinder the ability to abstain from tobacco use during a quit attempt.

SCALE-UP II: protocol for a pragmatic randomised trial examining population health management interventions to increase the uptake of at-home COVID-19 testing in community health centres.

INTRODUCTION: SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs). METHODS AND ANALYSIS: The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2×2×2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2×2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors. ETHICS AND DISSEMINATION: The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT05533918 and NCT05533359.

Deep sequencing of candidate genes identified 14 variants associated with smoking abstinence in an ethnically diverse sample.

Despite the large public health toll of smoking, genetic studies of smoking cessation have been limited with few discoveries of risk or protective loci. We investigated common and rare variant associations with success in quitting smoking using a cohort from 8 randomized controlled trials involving 2231 participants and a total of 10,020 common and 24,147 rare variants. We identified 14 novel markers including 6 mapping to genes previously related to psychiatric and substance use disorders, 4 of which were protective (CYP2B6 (rs1175607105), HTR3B (rs1413172952; rs1204720503), rs80210037 on chr15), and 2 of which were associated with reduced cessation (PARP15 (rs2173763), SCL18A2 (rs363222)). The others mapped to areas associated with cancer including FOXP1 (rs1288980) and ZEB1 (rs7349). Network analysis identified significant canonical pathways for the serotonin receptor signaling pathway, nicotine and bupropion metabolism, and several related to tumor suppression. Two novel markers (rs6749438; rs6718083) on chr2 are flanked by genes associated with regulation of bodyweight. The identification of novel loci in this study can provide new targets of pharmacotherapy and inform efforts to develop personalized treatments based on genetic profiles.

In-Clinic vs. Online Recruitment of Women with a History of Cervical Intraepithelial Neoplasia or Cervical Cancer to a Smoking Cessation Trial: A Post-hoc Comparison of Participant Characteristics, Study Retention, and Cessation Outcomes.

INTRODUCTION: Recruiting special populations to smoking cessation trials is challenging and approaches beyond in-clinic recruitment may be beneficial. This secondary analysis of data from a smoking cessation RCT for individuals with a history of cervical cancer or cervical intraepithelial neoplasia (CIN) explored differences associated with in-clinic vs. online recruitment. METHODS: Participants were recruited from clinics within a university-based NCI-designated cancer center (n=87) and online nationally via Facebook (n=115). Baseline measures included sociodemographics, smoking history, and cancer or CIN history. Study retention and smoking abstinence were assessed 12 months post-baseline. Group differences in baseline characteristics were evaluated. Retention and abstinence were evaluated while controlling for group differences and predictors. RESULTS: Participants recruited online (vs. in-clinic) had higher educational attainment (p=.01) and health literacy (p=.003). They were more likely to have CIN vs. cancer, to be further from the time of diagnosis, and to have completed active treatment (p values<.001). While controlling for these group differences and independent predictors, retention was higher among participants recruited online (log-likelihood χ2(1)=11.41, p<.001). There were no recruitment differences in self-reported (p=.90) or biochemically confirmed smoking abstinence (p=.18). CONCLUSIONS: Compared to individuals recruited in-person, individuals recruited online were more educated, had higher health literacy, and presented with a different clinical profile (i.e., more likely to have CIN vs. cancer and to have completed active treatment). There were few differences in participant characteristics between recruitment approaches, and no differences on any smoking-related variables. Online recruitment has the potential to improve enrollment of cancer survivors to smoking cessation trials. IMPLICATIONS: People with a history of CIN or cervical cancer recruited to a smoking cessation RCT online (vs. in-clinic) were more likely to have a diagnosis of CIN vs. cancer and were more educated and health literate. Participants recruited online were more likely to be retained in the study and there were no differences in smoking abstinence rates at 12-months. Incorporating online recruitment increased the reach of tobacco treatment efforts to a larger and more diverse sample. This could reduce the burden of tobacco-related disease, improve CIN and cancer treatment outcomes, and reduce secondary malignancies and morbidity among this underserved group.

Co-action and changes in alcohol use during a smoking cessation attempt.

AIMS: Three smoking cessation studies (CARE, Break Free, Por Nuestra Salud [PNS]) were used to measure changes in average alcohol consumption, binge drinking and alcohol-related problems during a smoking cessation attempt and to explore co-action with smoking abstinence. DESIGN: CARE and PNS were longitudinal cohort cessation studies; Break Free was a two-arm randomized clinical trial. SETTING: Texas, USA. PARTICIPANTS: Participants were current smokers who were recruited from the community and received smoking cessation interventions. All participants received nicotine replacement therapy and smoking cessation counseling. CARE included 424 smokers (1/3 White, 1/3 African American and 1/3 Latino); Break Free included 399 African American smokers; PNS included 199 Spanish-speaking Mexican-American smokers. MEASUREMENTS: Weekly alcohol consumption was collected multiple times pre and post-quit, and binge drinking and alcohol-related problems were collected at baseline and 26 weeks post-quit. Analyses included only those who indicated current alcohol use. FINDINGS: Average alcohol consumption decreased from baseline to 26 weeks post-quit in CARE (F = 17.09, P < 0.001), Break Free (F = 12.08, P < 0.001) and PNS (F = 10.21, P < 0.001). Binge drinking decreased from baseline to 26 weeks post-quit in CARE (F = 3.94, P = 0.04) and Break Free (F = 10.41, P < 0.001) but not PNS. Alcohol-related problems decreased from baseline to 26 weeks post-quit in CARE (Chi-sq = 6.41, P = 0.010) and Break Free (Chi sq = 14.44, P = 0.001), but not PNS. CONCLUSIONS: Among current drinkers, alcohol use/problems appear to decrease during a smoking cessation attempt and remain low through 26 weeks after the quit attempt. Little evidence was found for co-action, with smoking abstainers and relapsers showing similar change in alcohol use/problems.

#4Corners4Health Social Media Cancer Prevention Campaign for Emerging Adults: Protocol for a Randomized Stepped-Wedge Trial.

BACKGROUND: Many emerging adults (EAs) are prone to making unhealthy choices, which increase their risk of premature cancer morbidity and mortality. In the era of social media, rigorous research on interventions to promote health behaviors for cancer risk reduction among EAs delivered over social media is limited. Cancer prevention information and recommendations may reach EAs more effectively over social media than in settings such as health care, schools, and workplaces, particularly for EAs residing in rural areas. OBJECTIVE: This pragmatic randomized trial aims to evaluate a multirisk factor intervention using a social media campaign designed with community advisers aimed at decreasing cancer risk factors among EAs. The trial will target EAs from diverse backgrounds living in rural counties in the Four Corners states of Arizona, Colorado, New Mexico, and Utah. METHODS: We will recruit a sample of EAs (n=1000) aged 18 to 26 years residing in rural counties (Rural-Urban Continuum Codes 4 to 9) in the Four Corners states from the Qualtrics' research panel and enroll them in a randomized stepped-wedge, quasi-experimental design. The inclusion criteria include English proficiency and regular social media engagement. A social media intervention will promote guideline-related goals for increased physical activity, healthy eating, and human papillomavirus vaccination and reduced nicotine product use, alcohol intake, and solar UV radiation exposure. Campaign posts will cover digital and media literacy skills, responses to misinformation, communication with family and friends, and referral to community resources. The intervention will be delivered over 12 months in Facebook private groups and will be guided by advisory groups of community stakeholders and EAs and focus groups with EAs. The EAs will complete assessments at baseline and at 12, 26, 39, 52, and 104 weeks after randomization. Assessments will measure 6 cancer risk behaviors, theoretical mediators, and participants' engagement with the social media campaign. RESULTS: The trial is in its start-up phase. It is being led by a steering committee. Team members are working in 3 subcommittees to optimize community engagement, the social media intervention, and the measures to be used. The Stakeholder Organization Advisory Board and Emerging Adult Advisory Board were formed and provided initial input on the priority of cancer risk factors to target, social media use by EAs, and community resources available. A framework for the social media campaign with topics, format, and theoretical mediators has been created, along with protocols for campaign management. CONCLUSIONS: Social media can be used as a platform to counter misinformation and improve reliable health information to promote health behaviors that reduce cancer risks among EAs. Because of the popularity of web-based information sources among EAs, an innovative, multirisk factor intervention using a social media campaign has the potential to reduce their cancer risk behaviors. TRIAL REGISTRATION: ClinicalTrials.gov NCT05618158; https://classic.clinicaltrials.gov/ct2/show/NCT05618158. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/50392.

Preliminary effects of a rural skin cancer prevention intervention for youths.

OBJECTIVES: To pilot and assess the feasibility, acceptability, and preliminary effects of the Rural Adult and Youth Sun (RAYS) protection program, a multilevel skin cancer preventive intervention for young children living in rural U.S. communities, delivered through community-organized team sports. METHOD: Three rural counties in Utah participated with two receiving the intervention and the third serving as a control. Youth sports leagues were recruited through recreation departments and the study took place from May through October 2021. Intervention leagues received sun protection supplies for players and coaches, educational materials for parents, and coaches were offered training on skin cancer and sun protection behaviors. RESULTS: The RAYS program is both feasible to deliver and acceptable to coaches, parents, and players. The intervention also demonstrates beneficial preliminary effects on components of observed child sun-protective behaviors, coach sun protection behaviors, knowledge of skin cancer prevention recommendations, and self-efficacy in skin cancer prevention. CONCLUSIONS: Multilevel interventions for skin cancer prevention among young children can be successfully delivered through community organizations and their settings. A priority moving forward is the identification of ways to optimize delivery of such programs to positively influence skin cancer preventive behaviors among children living in diverse rural areas. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Use of implementation mapping in the planning of a hybrid type 1 pragmatic clinical trial: the BeatPain Utah study.

BACKGROUND: Considerable disparities in chronic pain management have been identified. Persons in rural, lower income, and minoritized communities are less likely to receive evidence-based, nonpharmacologic care. Telehealth delivery of nonpharmacologic, evidence-based interventions for persons with chronic pain is a promising strategy to lessen disparities, but implementation comes with many challenges. The BeatPain Utah study is a hybrid type 1 effectiveness-implementation pragmatic clinical trial investigating telehealth strategies to provide nonpharmacologic care from physical therapists to persons with chronic back pain receiving care in ommunity health centers (CHCs). CHCs provide primary care to all persons regardless of ability to pay. This paper outlines the use of implementation mapping to develop a multifaceted implementation plan for the BeatPain study. METHODS: During a planning year for the BeatPain trial, we developed a comprehensive logic model including the five-step implementation mapping process informed by additional frameworks and theories. The five iterative implementation mapping steps were addressed in the planning year: (1) conduct needs assessments for involved groups; (2) identify implementation outcomes, performance objectives, and determinants; (3) select implementation strategies; (4) produce implementation protocols and materials; and (5) evaluate implementation outcomes. RESULTS: CHC leadership/providers, patients, and physical therapists were identified as involved groups. Barriers and assets were identified across groups which informed identification of performance objectives necessary to implement two key processes: (1) electronic referral of patients with back pain in CHC clinics to the BeatPain team and (2) connecting patients with physical therapists providing telehealth. Determinants of the performance objectives for each group informed our choice of implementation strategies which focused on training, education, clinician support, and tailoring physical therapy interventions for telehealth delivery and cultural competency. We selected implementation outcomes for the BeatPain trial to evaluate the success of our implementation strategies. CONCLUSIONS: Implementation mapping provided a comprehensive and systematic approach to develop an implementation plan during the planning phase for our ongoing hybrid effectiveness-implementation trial. We will be able to evaluate the implementation strategies used in the BeatPain Utah study to inform future efforts to implement telehealth delivery of evidence-based pain care in CHCs and other settings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04923334 . Registered June 11, 2021.

Multiple imputation of missing data in multilevel ecological momentary assessments: an example using smoking cessation study data.

Advances in digital technology have greatly increased the ease of collecting intensive longitudinal data (ILD) such as ecological momentary assessments (EMAs) in studies of behavior changes. Such data are typically multilevel (e.g., with repeated measures nested within individuals), and are inevitably characterized by some degrees of missingness. Previous studies have validated the utility of multiple imputation as a way to handle missing observations in ILD when the imputation model is properly specified to reflect time dependencies. In this study, we illustrate the importance of proper accommodation of multilevel ILD structures in performing multiple imputations, and compare the performance of a multilevel multiple imputation (multilevel MI) approach relative to other approaches that do not account for such structures in a Monte Carlo simulation study. Empirical EMA data from a tobacco cessation study are used to demonstrate the utility of the multilevel MI approach, and the implications of separating participant- and study-initiated EMAs in evaluating individuals' affective dynamics and urge.

Increasing the reach of evidence-based interventions for weight management and diabetes prevention among Medicaid patients: study protocol for a pilot Sequential Multiple Assignment Randomised Trial.

INTRODUCTION: Over 40% of US adults meet criteria for obesity, a major risk factor for chronic disease. Obesity disproportionately impacts populations that have been historically marginalised (eg, low socioeconomic status, rural, some racial/ethnic minority groups). Evidence-based interventions (EBIs) for weight management exist but reach less than 3% of eligible individuals. The aims of this pilot randomised controlled trial are to evaluate feasibility and acceptability of dissemination strategies designed to increase reach of EBIs for weight management. METHODS AND ANALYSIS: This study is a two-phase, Sequential Multiple Assignment Randomized Trial, conducted with 200 Medicaid patients. In phase 1, patients will be individually randomised to single text message (TM1) or multiple text messages (TM+). Phase 2 is based on treatment response. Patients who enrol in the EBI within 12 weeks of exposure to phase 1 (ie, responders) receive no further interventions. Patients in TM1 who do not enrol in the EBI within 12 weeks of exposure (ie, TM1 non-responders) will be randomised to either TM1-Continued (ie, no further TM) or TM1 & MAPS (ie, no further TM, up to 2 Motivation And Problem Solving (MAPS) navigation calls) over the next 12 weeks. Patients in TM+ who do not enrol in the EBI (ie, TM+ non-responders) will be randomised to either TM+Continued (ie, monthly text messages) or TM+ & MAPS (ie, monthly text messages, plus up to 2 MAPS calls) over the next 12 weeks. Descriptive statistics will be used to characterise feasibility (eg, proportion of patients eligible, contacted and enrolled in the trial) and acceptability (eg, participant opt-out, participant engagement with dissemination strategies, EBI reach (ie, the proportion of participants who enrol in EBI), adherence, effectiveness). ETHICS AND DISSEMINATION: Study protocol was approved by the University of Utah Institutional Review Board (#00139694). Results will be disseminated through study partners and peer-reviewed publications. TRIAL REGISTRATION NUMBER: clinicaltrials.gov; NCT05666323.

Use of implementation mapping in the planning of a hybrid type 1 pragmatic clinical trial: the BeatPain Utah study.

Background: Considerable disparities in chronic pain management have been identified. Persons in rural, lower income and minoritized communities are less likely to receive evidence-based, nonpharmacologic care. Telehealth delivery of nonpharmacologic, evidence-based interventions for persons with chronic pain is a promising strategy to lessen disparities, but implementation comes with many challenges. The BeatPain Utah study is a hybrid type I effectiveness-implementation pragmatic clinical trial investigating telehealth strategies to provide nonpharmacologic care from physical therapists to persons with chronic back pain receiving care in Community Health Centers (CHCs). CHCs provide primary care to all persons regardless of ability to pay. This paper outlines the use of implementation mapping to develop a multifaceted implementation plan for the BeatPain study. Methods: During a planning year for the BeatPain trial we developed a comprehensive logic model including the 5-step implementation mapping process informed by additional frameworks and theories. The five iterative implementation mapping steps were addressed in the planning year; 1) conduct needs assessments for involved groups; 2) identify implementation outcomes, performance objectives and determinants; 3) select implementation strategies; 4) produce implementation protocols and materials; and 5) evaluate implementation outcomes. Results: CHC leadership/providers, patients and physical therapists were identified as involved groups. Barriers and assets were identified across groups which informed identification of performance objectives necessary to implement two key processes; 1) electronic referral of patients with back pain in CHC clinics to the BeatPain team; and 2) connecting patients with physical therapists providing telehealth. Determinants of the performance objectives for each group informed our choice of implementation strategies which focused on training, education, clinician support and tailoring physical therapy interventions for telehealth delivery and cultural competency. We selected implementation outcomes for the BeatPain trial to evaluate the success of our implementation strategies. Conclusions: Implementation mapping provided a comprehensive and systematic approach to develop an implementation plan during the planning phase for our ongoing hybrid effectiveness-implementation trial. We will be able to evaluate the implementation strategies used in the BeatPain Utah study to inform future efforts to implement telehealth delivery of evidence-based pain care in CHCs and other settings. Trial registration: Clinicaltrials.gov Identifier: NCT04923334. Registered June 11, 2021 (https://clinicaltrials.gov/study/NCT04923334.

Preliminary Reach of an Information Technology Approach to Support COVID-19 Testing in Schools.

OBJECTIVES: SCALE-UP Counts tests population health management interventions to promote coronavirus disease 2019 (COVID-19) testing in kindergarten through 12th-grade schools that serve populations that have been historically marginalized. METHODS: Within 6 participating schools, we identified 3506 unique parents/guardians who served as the primary contact for at least 1 student. Participants were randomized to text messaging (TM), text messaging + health navigation (HN) (TM + HN), or usual care. Bidirectional texts provided COVID-19 symptom screening, along with guidance on obtaining and using tests as appropriate. If parents/guardians in the TM + HN group were advised to test their child but either did not test or did not respond to texts, they were called by a trained health navigator to address barriers. RESULTS: Participating schools served a student population that was 32.9% non-white and 15.4% Hispanic, with 49.6% of students eligible to receive free lunches. Overall, 98.8% of parents/guardians had a valid cell phone, of which 3.8% opted out. Among the 2323 parents/guardians included in the intervention, 79.6% (n = 1849) were randomized to receive TM, and 19.1% (n = 354) engaged with TM (ie, responded to at least 1 message). Within the TM + HN group (40.1%, n = 932), 1.3% (n = 12) qualified for HN at least once, of which 41.7% (n = 5) talked to a health navigator. CONCLUSIONS: TM and HN are feasible ways to reach parents/guardians of kindergarten through 12th-grade students to provide COVID-19 screening messages. Strategies to improve engagement may strengthen the impact of the intervention.

Building School-Academic Partnerships to Implement COVID-19 Testing in Underserved Populations.

OBJECTIVE: In April 2021, the US government made substantial investments in students' safe return to school by providing resources for school-based coronavirus disease 2019 (COVID-19) mitigation strategies, including COVID-19 diagnostic testing. However, testing uptake and access among vulnerable children and children with medical complexities remained unclear. METHODS: The Rapid Acceleration of Diagnostics Underserved Populations program was established by the National Institutes of Health to implement and evaluate COVID-19 testing programs in underserved populations. Researchers partnered with schools to implement COVID-19 testing programs. The authors of this study evaluated COVID-19 testing program implementation and enrollment and sought to determine key implementation strategies. A modified Nominal Group Technique was used to survey program leads to identify and rank testing strategies to provide a consensus of high-priority strategies for infectious disease testing in schools for vulnerable children and children with medical complexities. RESULTS: Among the 11 programs responding to the survey, 4 (36%) included prekindergarten and early care education, 8 (73%) worked with socioeconomically disadvantaged populations, and 4 focused on children with developmental disabilities. A total of 81 916 COVID-19 tests were performed. "Adapting testing strategies to meet the needs, preferences, and changing guidelines," "holding regular meetings with school leadership and staff," and "assessing and responding to community needs" were identified as key implementation strategies by program leads. CONCLUSIONS: School-academic partnerships helped provide COVID-19 testing in vulnerable children and children with medical complexities using approaches that met the needs of these populations. Additional work is needed to develop best practices for in-school infectious disease testing in all children.

Research-practice partnership: supporting rural cancer survivors in Montana.

The objective of this Research-Practice Partnership was to disseminate and implement strategies to assist Community Health Centers in improving the care of rural cancer survivors in Montana. Funded by the National Cancer Institute's Community Outreach and Engagement mechanism, this project utilized the MAP-IT (Mobilize, Assess, Plan, Implement, Track) program planning framework from Healthy People 2020. Partners included Montana's Department of Public Health and Human Services' Cancer Control Program, Montana Primary Care Association, One Health Community Health Center, and Huntsman Cancer Institute at the University of Utah. Project activities focused on (1) Planning, creating, implementing, and evaluating provider/care team education sessions through the Project ECHO tele-mentoring platform and through short webinars and (2) Building processes for identifying, documenting, and connecting with survivors using electronic health records (EHRs) and other resources. Lessons learned from this project include the value of aligning partner goals from the outset to foster sustained commitment, the importance of adapting implementation plans to address challenges and leverage opportunities, and the need for accurate EHR data and formal processes for identifying and engaging with cancer survivors.

The Effects of Scheduled Smoking Reduction and Precessation Nicotine Replacement Therapy on Smoking Cessation: Randomized Controlled Trial With Compliance.

BACKGROUND: Smoking remains a major public health problem, and it is important to provide a variety of efficacious and appealing options to encourage smokers to quit smoking. Scheduled smoking is a method of gradual reduction, preparing smokers to quit by systematically reducing cigarette consumption according to a predetermined schedule that increases the time between cigarette consumption. Gradual reduction may be preferred to abrupt quitting, but the efficacy of this cessation approach is unclear. OBJECTIVE: This study aims, first, to evaluate the overall effectiveness of scheduled smoking alone, or in combination with precessation nicotine replacement therapy (NRT), versus standard NRT starting on the quit date with no prior smoking reduction and, second, to evaluate the impact of schedule compliance on the effectiveness of the intervention. METHODS: A total of 916 participants recruited from the Houston metropolitan area were randomly assigned to 1 of the following 3 groups: scheduled smoking plus a precessation nicotine patch (n=306, 33.4%), scheduled smoking only with no precessation patch (n=309, 33.7%), and enhanced usual care (n=301, 32.9%) control. The primary abstinence outcomes were carbon monoxide-verified, self-reported, 7-day point prevalence abstinence at 2 and 4 weeks after the quit date. Unadjusted and adjusted logistic regression analyses were performed to evaluate the intervention effect. Scheduled smoking was implemented using a handheld device for 3 weeks before quitting. This trial was not registered because data collection began before July 1, 2005. RESULTS: Results for the first aim showed no overall differences in abstinence among the 3 groups in both the unadjusted and adjusted models. However, the results for the second aim showed a clear effect on abstinence by schedule compliance at 2 and 4 weeks and 6 months after quitting (odds ratio [OR] 2.01, 95% CI 1.31-3.07), 4 weeks (OR 1.58, 95% CI 1.05-2.38), and 6 months (OR 1.68, 95% CI 1.04-2.64), with the differences at 2 and 4 weeks after quitting being the most robust. We also found that scheduled smoking was related to a reduction in nicotine withdrawal, negative affect, and craving when compared with the controls. CONCLUSIONS: Scheduled smoking, when combined with precessation use of NRT, can result in significantly higher abstinence rates than usual care (abrupt quitting with NRT), particularly in the early postquit phase (2 and 4 weeks after cessation) when smokers are compliant with the procedure. Scheduled smoking also produced a better overall quitting experience by reducing symptoms of nicotine withdrawal and craving, in comparison with usual care, which could encourage future quit attempts. Studies in this area should focus on the use of counseling or other methods to improve adherence.

Time-varying model of engagement with digital self reporting: Evidence from smoking cessation longitudinal studies.

Objective: Insufficient engagement is a critical barrier impacting the utility of digital interventions and mobile health assessments. As a result, engagement itself is increasingly becoming a target of studies and interventions. The purpose of this study is to investigate the dynamics of engagement in mobile health data collection by exploring whether, how, and why response to digital self-report prompts change over time in smoking cessation studies. Method: Data from two ecological momentary assessment (EMA) studies of smoking cessation among diverse smokers attempting to quit (N = 573) with a total of 65,974 digital self-report prompts. We operationalize engagement with self-reporting in term of prompts delivered and prompt response to capture both broad and more granular engagement in self-reporting, respectively. The data were analyzed to describe trends in prompt delivered and prompt response over time. Time-varying effect modeling (TVEM) was employed to investigate the time-varying effects of response to previous prompt and the average response rate on the likelihood of current prompt response. Results: Although prompt response rates were relatively stable over days in both studies, the proportion of participants with prompts delivered declined steadily over time in one of the studies, indicating that over time, fewer participants charged the device and kept it turned on (necessary to receive at least one prompt per day). Among those who did receive prompts, response rates were relatively stable. In both studies, there is a significant, positive and stable relationship between response to previous prompt and the likelihood of response to current prompt throughout all days of the study. The relationship between the average response rate prior to current prompt and the likelihood of responding to the current prompt was also positive, and increasing with time. Conclusion: Our study highlights the importance of integrating various indicators to measure engagement in digital self-reporting. Both average response rate and response to previous prompt were highly predictive of response to the next prompt across days in the study. Dynamic patterns of engagement in digital self-reporting can inform the design of new strategies to promote and optimize engagement in digital interventions and mobile health studies.

Integrating Intensive Longitudinal Data (ILD) to Inform the Development of Dynamic Theories of Behavior Change and Intervention Design: a Case Study of Scientific and Practical Considerations.

The increasing sophistication of mobile and sensing technology has enabled the collection of intensive longitudinal data (ILD) concerning dynamic changes in an individual's state and context. ILD can be used to develop dynamic theories of behavior change which, in turn, can be used to provide a conceptual framework for the development of just-in-time adaptive interventions (JITAIs) that leverage advances in mobile and sensing technology to determine when and how to intervene. As such, JITAIs hold tremendous potential in addressing major public health concerns such as cigarette smoking, which can recur and arise unexpectedly. In tandem, a growing number of studies have utilized multiple methods to collect data on a particular dynamic construct of interest from the same individual. This approach holds promise in providing investigators with a significantly more detailed view of how a behavior change processes unfold within the same individual than ever before. However, nuanced challenges relating to coarse data, noisy data, and incoherence among data sources are introduced. In this manuscript, we use a mobile health (mHealth) study on smokers motivated to quit (Break Free; R01MD010362) to illustrate these challenges. Practical approaches to integrate multiple data sources are discussed within the greater scientific context of developing dynamic theories of behavior change and JITAIs.

Acceptance and Commitment Therapy Wellness Program for Latine Adults Who Smoke and Have Psychological Distress: Protocol for a Feasibility Study.

BACKGROUND: Tobacco smoking is a major independent risk factor for chronic disease, and the prevalence of smoking among people with behavioral health disorders is 2-fold in comparison with the general population. Smoking rates remain high for various subgroups within the Latine community, the largest ethnic minority group in the United States. Acceptance and commitment therapy (ACT) is a theoretically sound and clinically validated therapeutic approach for several behavioral health conditions with growing evidence of its effectiveness for smoking cessation. Unfortunately, the evidence of ACT effectiveness for smoking cessation among Latine individuals is scarce, and none of the existing studies have tested a culturally targeted intervention for this population. OBJECTIVE: This study aims to address the co-occurrence of smoking and mood-related challenges among Latine adults via the development and testing of a culturally tailored ACT-based wellness program: Project PRESENT. METHODS: This study entails 2 phases. Phase 1 consists of the intervention development. Phase 2 entails the pilot testing of the behavioral intervention along with the administration of baseline and follow-up measures to 38 participants. Primary outcomes include feasibility of recruitment and retention, and treatment acceptability. Secondary outcomes are smoking status and depression and anxiety scores at end of treatment and 1-month follow-up. RESULTS: This study received institutional review board approval. Phase 1 outputs were the health counselors' treatment manual and participant guide. Recruitment was completed in 2021. Phase 2 outcomes will be determined after project implementation and data analyses are complete, which are expected by May 2023. CONCLUSIONS: Findings from this study will determine the feasibility and acceptability of an ACT-based, culturally relevant intervention for Latine adults who smoke and have probable depression and/or anxiety. We expect feasibility of recruitment, retention and treatment acceptability, and reductions in smoking status, depression, and anxiety. If feasible and acceptable, the study will inform large-scale trials, which will ultimately contribute to narrowing the gap between research and clinical practice for the co-occurrence of smoking and psychological distress among Latine adults. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44146.

Efficacy of a Smoking Cessation Intervention for Survivors of Cervical Intraepithelial Neoplasia or Cervical Cancer: A Randomized Controlled Trial.

PURPOSE: Women who smoke and have a history of cervical intraepithelial neoplasia (CIN) or cervical cancer represent a vulnerable subgroup at elevated risk for recurrence, poorer cancer treatment outcomes, and decreased quality of life. The purpose of this study was to evaluate the long-term efficacy of Motivation And Problem Solving (MAPS), a novel treatment well-suited to meeting the smoking cessation needs of this population. METHODS: Women who were with a history of CIN or cervical cancer, age 18 years and older, spoke English or Spanish, and reported current smoking (≥100 lifetime cigarettes plus any smoking in the past 30 days) were eligible. Participants (N = 202) were recruited in clinic in Oklahoma City and online nationally and randomly assigned to (1) standard treatment (ST) or (2) MAPS. ST consisted of repeated referrals to a tobacco cessation quitline, self-help materials, and combination nicotine replacement therapy (patch plus lozenge). MAPS comprised all ST components plus up to six proactive telephone counseling sessions over 12 months. Logistic regression and generalized estimating equations evaluated the intervention. The primary outcome was self-reported 7-day point prevalence abstinence from tobacco at 18 months, with abstinence at 3, 6, and 12 months and biochemically confirmed abstinence as secondary outcomes. RESULTS: There was no significant effect for MAPS over ST at 18 months (14.2% v 12.9%, P = .79). However, there was a significant condition × assessment interaction (P = .015). Follow-up analyses found that MAPS (v ST) abstinence rates were significantly greater at 12 months (26.4% v 11.9%, P = .017; estimated OR, 2.60; 95% CI, 1.19 to 5.89). CONCLUSION: MAPS led to a greater than two-fold increase in smoking abstinence among survivors of CIN and cervical cancer at 12 months. At 18 months, abstinence in MAPS declined to match the control condition and the treatment effect was no longer significant.