Anxiety sensitivity and COVID-19 mental health, fatigue, and well-being: a longitudinal examination among adults from the United States during March-October 2020.

There is widespread empirical evidence that the COVID-19 pandemic contributed to elevated risk of mental and physical health symptoms and decreased quality of life. The present investigation sought to examine if individual differences in anxiety sensitivity was associated with mental health, psychosomatic, and well-being among a sample of US adults during a 6-month period early in the COVID-19 pandemic. Employing longitudinal research methodology, we tested the hypothesis that the anxiety sensitivity global factor would be related to increased risk of anxiety, depression, fatigue, and lower well-being. Secondary analyses evaluated the lower order anxiety sensitivity factors for the same criterion variables. The sample consisted of 778 participants with an average age of 37.96 (SD = 11.81; range 18-73). Results indicated that, as hypothesized, anxiety sensitivity was associated with increased risk for more severe anxiety, depression, fatigue, and lesser well-being; the observed effects of anxiety sensitivity were relatively robust and evident in adjusted models that controlled for numerous theoretically and clinically relevant factors (e.g. perceived health status). Overall, these results suggest that pandemic functioning could likely be improved via interventions that target elevated anxiety sensitivity as a vulnerability factor for a broad range of aversive psychosomatic symptoms and personal well-being.

Project phoenix: Pilot randomized controlled trial of a smartphone-delivered intervention for people who are not ready to quit smoking.

BACKGROUND: Most people who smoke cigarettes report they want to quit in the future, but only 20 % are ready to quit within the next 30 days. This 3-arm pilot randomized controlled trial examined the feasibility and initial efficacy of a novel smartphone-based intervention that aimed to induce smoking cessation attempts among adults not initially ready to quit. METHODS: Participants randomized into the two intervention groups (Group 1: Phoenix App Only; Group 2: Phoenix App + Nicotine Replacement Therapy) received daily smoking cessation messages via smartphone application that were tailored to their current readiness to quit, while the attention control group (i.e., Factoid) received messages not related to smoking cessation. All participants completed a weekly survey for 26 weeks and used the app to set quit dates when/if desired. RESULTS: Participants (N=152) were female (67.8 %), White (75.7 %), 50.0 years old (SD=12.5), and smoked 20.4 cigarettes per day (SD=10.5). Results indicated that the Phoenix interventions were feasible (e.g., participants viewed ~185 messages over 26 weeks; 74.8 % of weekly surveys were completed; 85.5 % completed the 26-week follow-up assessment). Phoenix participants set more quit dates, set quit dates sooner, were abstinent for more days, and used smoking cessation medications on more days than those assigned to the Factoid group. CONCLUSIONS: This low-burden, smartphone-based smoking cessation induction intervention may increase smoking cessation attempts, and may reduce barriers that are encountered with traditional in-person or call-based interventions. TRIAL REGISTRATION: Clinicaltrials.gov number: NCT03405129; https://clinicaltrials.gov/ct2/show/NCT03405129.

Does the Relationship between Affect and Social Interactions among Adults Experiencing Homelessness Differ during Moments when at a Shelter versus Not?

The prevalence of alcohol use disorders is higher amongst adults experiencing homelessness (AEH) compared with domiciled adults. Greater exposure to heavy drinkers increases personal risk for heavy alcohol use. AEH spend substantial periods of time at shelters and report greater pressure to use alcohol when near shelter locations, as well as greater negative affect when near a shelter. It is unclear if the relationship between affect and 1) interacting with people and 2) being near someone AEH drank alcohol with before differs when AEH are at a shelter versus not. AEH reporting alcohol misuse (n = 72, Mage= 47, 85% Male, 68% Non-White) completed five daily smartphone-based ecological momentary assessments (EMAs) over 28 days. Generalized multilevel modeling revealed that when AEH were interacting with someone they drank with before, they had significantly lower positive affect when at a shelter (b = -0.17, p = 0.05), versus when not (b = 0.00, p = 0.99). AEH are likely to interact with previous drinking partners while at shelters. It may be important to deliver real-time treatment messages targeting affect in these moments, as well as deliver alcohol reduction/abstinence messages.

Smartphone-Based Survey and Message Compliance in Adults Initially Unready to Quit Smoking: Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Efficacy of smartphone-based interventions depends on intervention content quality and level of exposure to that content. Smartphone-based survey completion rates tend to decline over time; however, few studies have identified variables that predict this decline over longer-term interventions (eg, 26 weeks). OBJECTIVE: This study aims to identify predictors of survey completion and message viewing over time within a 26-week smoking cessation trial. METHODS: This study examined data from a 3-group pilot randomized controlled trial of adults who smoke (N=152) and were not ready to quit smoking within the next 30 days. For 182 days, two intervention groups received smartphone-based morning and evening messages based on current readiness to quit smoking. The control group received 2 daily messages unrelated to smoking. All participants were prompted to complete 26 weekly smartphone-based surveys that assessed smoking behavior, quit attempts, and readiness to quit. Compliance was operationalized as percentages of weekly surveys completed and daily messages viewed. Linear regression and mixed-effects models were used to identify predictors (eg, intervention group, age, and sex) of weekly survey completion and daily message viewing and decline in compliance over time. RESULTS: The sample (mean age 50, SD 12.5, range 19-75 years; mean years of education 13.3, SD 1.6, range 10-20 years) was 67.8% (n=103) female, 74.3% (n=113) White, 77% (n=117) urban, and 52.6% (n=80) unemployed, and 61.2% (n=93) had mental health diagnoses. On average, participants completed 18.3 (71.8%) out of 25.5 prompted weekly surveys and viewed 207.3 (60.6%) out of 345.1 presented messages (31,503/52,460 total). Age was positively associated with overall weekly survey completion (P=.003) and daily message viewing (P=.02). Mixed-effects models indicated a decline in survey completion from 77% (114/148) in the first week of the intervention to 56% (84/150) in the last week of the intervention (P<.001), which was significantly moderated by age, sex, ethnicity, municipality (ie, rural/urban), and employment status. Similarly, message viewing declined from 72.3% (1533/2120) in the first week of the intervention to 44.6% (868/1946) in the last week of the intervention (P<.001). This decline in message viewing was significantly moderated by age, sex, municipality, employment status, and education. CONCLUSIONS: This study demonstrated the feasibility of a 26-week smartphone-based smoking cessation intervention. Study results identified subgroups that displayed accelerated rates in the decline of survey completion and message viewing. Future research should identify ways to maintain high levels of interaction with mobile health interventions that span long intervention periods, especially among subgroups that have demonstrated declining rates of intervention engagement over time. TRIAL REGISTRATION: ClinicalTrials.gov NCT03405129; https://clinicaltrials.gov/ct2/show/NCT03405129.

An Integrated mHealth App for Smoking Cessation in Black Smokers With HIV: Protocol for a Randomized Controlled Trial.

BACKGROUND: Black adults who smoke and have HIV experience immense stressors (eg, racial discrimination and HIV stigma) that impede smoking cessation success and perpetuate smoking-related health disparities. These stressors also place Black adults who smoke and have HIV at an increased risk of elevated interoceptive stress (eg, anxiety and uncomfortable bodily sensations) and smoking to manage symptoms. In turn, this population is more likely to smoke to manage interoceptive stress, which contributes to worse HIV-related outcomes in this group. However, no specialized treatment exists to address smoking cessation, interoceptive stress, and HIV management for Black smokers with HIV. OBJECTIVE: This study aims to test a culturally adapted and novel mobile intervention that targets combustible cigarette smoking, HIV treatment engagement and adherence, and anxiety sensitivity (a proxy for difficulty and responsivity to interoceptive stress) among Black smokers with HIV (ie, Mobile Anxiety Sensitivity Program for Smoking and HIV [MASP+]). Various culturally tailored components of the app are being evaluated for their ability to help users quit smoking, manage physiological stress, and improve health care management. METHODS: This study is a pilot randomized controlled trial in which Black combustible cigarette smokers with HIV (N=72) are being recruited and randomly assigned to use either (1) the National Cancer Institute's QuitGuide app or (2) MASP+. Study procedures include a web-based prescreener; active intervention period for 6 weeks; smartphone-based assessments, including daily app-based ecological momentary assessments for 6 weeks (4 ecological momentary assessments each day); a video-based qualitative interview using Zoom Video Communications software at week 6 for participants in all study conditions; and smartphone-based follow-up assessments at 0, 1, 2 (quit date), 3, 4, 5, 6, and 28 weeks postbaseline (26 weeks postquitting date). RESULTS: Primary outcomes include biochemically verified 7-day point prevalence of abstinence, HIV-related quality of life, use of antiretroviral therapy, and HIV care appointment adherence at 26 weeks postquitting date. Qualitative data are also being collected and assessed to obtain feedback that will guide further tailoring of app content and evaluation of efficacy. CONCLUSIONS: The results of this study will determine whether the MASP+ app serves as a successful aid for combustible cigarette smoking cessation, HIV treatment engagement, and physiological stress outcomes among Black people with HIV infection. If successful, this study will provide evidence for the efficacy of a new means of addressing major mental and physical health difficulties for this high-risk population. If the results are promising, the data from this study will be used to update and tailor the MASP+ app for testing in a fully powered randomized controlled trial that will evaluate its efficacy in real-world behavioral health and social service settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT05709002; https://clinicaltrials.gov/study/NCT05709002. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/52090.

Impact of Nicotine Replacement Therapy Sampling on Cessation-Related Processes.

OBJECTIVES: Smoking prevalence remains high among low-income smokers. Understanding processes (eg, withdrawal, craving, motivation) in early smoking cessation is crucially important for designing effective interventions for this population. METHODS: This is a secondary analysis of a novel, in-session sampling intervention (ie, In Vivo) as compared with standard care behavioral smoking cessation counseling (SC) among community-dwelling low-income smokers (n = 83). This analysis examined the effect of 5 in-session sampling interventions on cessation-related processes and perceived advantages or disadvantages of nicotine replacement therapy (NRT) products over time using daily diaries. RESULTS: The In Vivo treatment had an early positive impact in terms of decreasing withdrawal symptoms and cravings, and increasing perceived advantages to NRT, with moderate to large effect sizes. Results also showed that the treatment effectively reduced withdrawal symptoms and cravings in-session, with small-to-medium and medium-to-large effect sizes, respectively. In-session reduction of withdrawal symptoms and cravings did not occur for the SC group, with the exception of decreased withdrawal symptoms occurring during week 4. The In Vivo treatment did not impact quit goal, desire to quit, abstinence self-efficacy, perceived difficulty in quitting, motivational engagement, or perceived disadvantages to NRT. The In Vivo group reported less daily cigarette use relative to the SC group, in addition to reporting less cigarette use on days they reported greater combination NRT use. CONCLUSIONS: There is preliminary support for this In Vivo treatment over SC in reducing withdrawal, craving, and the number of cigarettes smoked per day, as well as promoting perceived advantages of NRT among low-income smokers.

Mobile Intervention to Address Cannabis Use Disorder Among Black Adults: Protocol for a Randomized Controlled Trial.

BACKGROUND: African American or Black (hereafter referred to as Black) adults who use cannabis use it more frequently and are more likely to meet criteria for cannabis use disorder (CUD) than both White and Hispanic or Latin individuals. Black adults may be more apt to use cannabis to cope with distress, which constitutes a false safety behavior (FSB; a behavior designed to reduce psychological distress in the short term). Although FSB engagement can perpetuate the cycle of high rates of CUD among Black individuals, limited work has applied an FSB elimination treatment approach to Black adults with CUD, and no previous work has evaluated FSB reduction or elimination in the context of a culturally tailored and highly accessible treatment developed for Black individuals. OBJECTIVE: This study aims to develop and pilot-test a culturally tailored adaptive intervention that integrates FSB reduction or elimination skills for cannabis reduction or cessation among Black adults with probable CUD (Culturally Tailored-Mobile Integrated Cannabis and Anxiety Reduction Treatment [CT-MICART]). METHODS: Black adults with probable CUD (N=50) will complete a web-based screener, enrollment call, baseline assessment, 3 daily ecological momentary assessments (EMAs) for 6 weeks, and a follow-up self-report assessment and qualitative interview at 6 weeks after randomization. Participants will be randomized into 1 out of the 2 conditions after baseline assessment: (1) CT-MICART+EMAs for 6 weeks or (2) EMAs only for 6 weeks. RESULTS: The enrollment started in June 2023 and ended in November 2023. Data analysis will be completed in March 2024. CONCLUSIONS: No culturally tailored, evidence-based treatment currently caters to the specific needs of Black individuals with CUD. This study will lay the foundation for a new approach to CUD treatment among Black adults that is easily accessible and has the potential to overcome barriers to treatment and reduce practitioner burden in order to support Black individuals who use cannabis with probable CUD. TRIAL REGISTRATION: ClinicalTrials.gov NCT05566730; https://clinicaltrials.gov/study/NCT05566730. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52776.

Mobile Health Interventions for Substance Use Disorders.

Substance use disorders (SUDs) have an enormous negative impact on individuals, families, and society as a whole. Most individuals with SUDs do not receive treatment because of the limited availability of treatment providers, costs, inflexible work schedules, required treatment-related time commitments, and other hurdles. A paradigm shift in the provision of SUD treatments is currently underway. Indeed, with rapid technological advances, novel mobile health (mHealth) interventions can now be downloaded and accessed by those that need them anytime and anywhere. Nevertheless, the development and evaluation process for mHealth interventions for SUDs is still in its infancy. This review provides a critical appraisal of the significant literature in the field of mHealth interventions for SUDs with a particular emphasis on interventions for understudied and underserved populations. We also discuss the mHealth intervention development process, intervention optimization, and important remaining questions. Expected final online publication date for the Annual Review of Clinical Psychology, Volume 20 is May 2024. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

Development and pre-pilot testing of STAMP + CBT: an mHealth app combining pain cognitive behavioral therapy and opioid support for patients with advanced cancer and pain.

PURPOSE: We developed and piloted a mobile health app to deliver cognitive behavioral therapy for pain (pain-CBT), remote symptom monitoring, and pharmacologic support for patients with pain from advanced cancer. METHODS: Using an iterative process of patient review and feedback, we developed the STAMP + CBT app. The app delivers brief daily lessons from pain-CBT and pain psychoeducation, adapted for advanced cancer. Daily surveys assess physical symptoms, psychological symptoms, opioid utilization and relief. Just-in-time adaptive interventions generate tailored psychoeducation in response. We then conducted a single-arm pilot feasibility study at two cancer centers. Patients with advanced cancer and chronic pain used the app for 2 or 4 weeks, rated its acceptability and provided feedback in semi-structured interviews. Feasibility and acceptability were defined as ≥ 70% of participants completing ≥ 50% of daily surveys, and ≥ 80% of acceptability items rated ≥ 4/5. RESULTS: Fifteen participants (female = 9; mean age = 50.3) tested the app. We exceeded our feasibility and accessibility benchmarks: 73% of patients completed ≥ 50% of daily surveys; 87% of acceptability items were rated ≥ 4/5. Participants valued the app's brevity, clarity, and salience, and found education on stress and pain to be most helpful. The app helped participants learn pain management strategies and decrease maladaptive thoughts. However, participants disliked the notification structure (single prompt with one snooze), which led to missed content. CONCLUSION: The STAMP + CBT app was an acceptable and feasible method to deliver psychological/behavioral treatment with pharmacologic support for cancer pain. The app is being refined and will be tested in a larger randomized pilot study. TRN: NCT05403801 (05/06/2022).

American Indian Perspectives on Culturally Aligning a Digital Smoking Cessation Resource.

INTRODUCTION: Innovative smoking cessation approaches that overcome barriers such as traveling to program site or that require the staff and infrastructure for sustaining are likely needed to improve smoking quit rates among American Indian (AI) peoples in the United States. In this study, qualitative methods identified recommendations from AI peoples to guide alignment of an evidence-based smoking cessation smartphone app (i.e., QuitGuide) to the culture and needs of AI persons. METHODS: Semi-structured interviews were conducted with AI adults who smoke (n = 40) and with public health professionals (n = 6). Questions included: "The app asks if something triggered you to slip and lists several options. What options were you expecting to see on this list?" as well as how to make the app more engaging such as "What would make the app more helpful for AI peoples, like you, who want to quit smoking?." Constant comparative techniques were used to develop codes and themes. RESULTS: Loss, grief, and not accessing traditional tobacco were put forward as smoking triggers to be addressed in the app. Features that help users connect with and learn about AI cultures and promote healing, such as encouraging traditional tobacco use, being in community, embracing Native spirituality, and participating in cultural crafting were recommended. Some noted the need to motivate AI peoples to think about legacy and ability to care for younger generations and Indigenizing the app with Native imagery. CONCLUSIONS: Themes pointed towards promotion of strengths-based factors, such as healing, cultural connectedness and traditional tobacco use, in the app. IMPLICATIONS: Results will be used to culturally align a smartphone app for smoking cessation among AI peoples and may be insightful for other tribal, federal, and state public health efforts aimed at advancing health equity for AI peoples.

Greater Discrimination Frequency and Lower Distress Tolerance Are Associated with Mental Health Problems Among Racially Privileged and Minoritized Adults Accessing an Urban Day Shelter.

INTRODUCTION: Discrimination experiences may be a contributing factor to the elevated prevalence of mental health problems among adults experiencing homelessness. METHODS: Using survey data (N = 552) collected from adults seeking services at an urban day shelter, the relationships between everyday and major discrimination experiences, distress tolerance, and mental health problems (depression, anxiety, post-traumatic stress disorder, poor mental health days) were characterized. Distress tolerance was examined as a moderator of the relationship between discrimination and mental health problems. RESULTS: Participants were predominantly from racially minoritized groups (59.6%), non-Hispanic (88.7%), and male (70.9%), with an average age of 45.7 years old (SD = 11.7). Descriptive analyses indicated that the main reason for discrimination differed between racially privileged (i.e., White participants) and racially minoritized participants (i.e., participants who identified as Black, American Indian/Alaska Native, Asian, Native Hawaiian/Pacific Islander, or multi-race), such that homelessness was most commonly endorsed among racially privileged participants while racial discrimination was most commonly reported among racially minoritized participants. Multivariate logistic regression analyses revealed associations between everyday discrimination, major discrimination, and distress tolerance with mental health problems. Distress tolerance did not moderate the relations between discrimination and mental health problems in most analyses. Notably, major discrimination was no longer associated with all mental health variables when both everyday and major discrimination were included in all models. CONCLUSION: Findings suggest that reducing everyday discrimination and addressing the adverse impact of everyday discrimination experiences may have a beneficial impact on mental health.

Anxiety Sensitivity and Distress Tolerance in Relation to Smoking Abstinence Expectancies Among Black Individuals Who Smoke.

OBJECTIVE: Black individuals who smoke in the United States experience significant tobacco-related disparities. Although prior work has established that smoking abstinence expectancies play an important role in smoking-related outcomes, few studies have examined potential individual difference factors that may be relevant to smoking abstinence expectancies among Black individuals who smoke. The present study investigated anxiety sensitivity and distress tolerance in relation to smoking abstinence expectancies among a sample of Black individuals who smoke. METHOD: Participants were 86 Black adults who smoke cigarettes daily (M age = 46.07 years, SD = 10.37; 26.7% female). Four separate linear regression analyses were conducted to evaluate the relation between anxiety sensitivity, distress tolerance, and their interaction with each of the four smoking abstinence expectancies (i.e., somatic symptoms, positive consequences, harmful consequences, and negative mood). RESULTS: Results indicated that higher anxiety sensitivity was related to higher somatic symptoms, harmful consequences, and negative mood abstinence expectancies, whereas distress tolerance was related to higher positive consequences. Further, anxiety sensitivity and distress tolerance interacted to confer greater expectancies for the positive consequences of quitting. CONCLUSIONS: The current findings are among the first to document that anxiety sensitivity and distress tolerance are clinically relevant factors to consider when tailoring smoking cessation treatments for Black individuals who smoke. Future research is needed to examine distress tolerance and anxiety sensitivity as longitudinal predictors of smoking abstinence expectancies among Black individuals who smoke.

The association of sleep with physical and mental health among people experiencing homelessness.

BACKGROUND: Sleep deprivation is a critical risk factor for physical and mental health problems. The current study examined whether sleep problems were related to housing status and physical and mental health among people experiencing homelessness. METHODS: Data were collected via an anonymous survey completed by adults accessing services at a day shelter in Oklahoma City, OK. Demographic characteristics, sleep problems, days of poor physical and mental health, and self-rated health were assessed and compared across housing subgroups. Logistic regression analyses were performed to examine potential associations between sleep and health. RESULTS: Participants (N = 404) were predominantly male (71.0%) and racially minoritized (57.4%) with an average age of 47.0 (SD=11.6) years. Days of unintentional sleep over the past 30days differed significantly by housing status. Logistic regression analyses indicated that short sleep duration of ≤6 hours was associated with poorer self-rated health and more days of poor physical health over the past 30days compared to those who reported an optimal sleep duration of 7-9 hours. Additionally, reporting ≥1 day of unintentional daytime sleep was associated with more days of poor mental and physical health over the past 30-day. Reporting more days of inadequate sleep was associated with poorer self-rated health, and more days of poor physical and mental health over the past 30days. CONCLUSION: Sleep problems were associated with poorer physical and mental health among people experiencing homelessness. Safe environments where adults experiencing homelessness can sleep comfortably and without interruption may be needed to support good physical and mental health.

Associations between morning affect and later-day smoking urges and behavior.

OBJECTIVE: Affective experiences are associated with smoking urges and behavior. Few studies have examined the temporal nature of these associations within a day, such as whether positive and negative affect in the morning are associated with smoking urges and behavior later in the day. METHOD: Participants (N = 63; MAge = 50 years, 48% female; 60% White) were randomized into one of three smoking cessation interventions and answered up to five daily ecological momentary assessments for 28 days during a quit attempt (M = 21.0 days, SD = 7.1). Before analysis, scores for morning positive and negative affect and later-day smoking urges and behavior were calculated. RESULTS: On days when individuals' morning positive affect was higher than usual, later-day smoking urges tended to be lower than usual. In contrast, on days when individuals' morning negative affect was higher than usual, later-day smoking urges tended to be higher than usual, and smoking was more likely. Further, individuals who had higher characteristic morning positive affect tended to have less intense later-day smoking urges, whereas those who tended to have higher characteristic morning negative affect tended to have more intense later-day smoking urges. CONCLUSIONS: Morning positive and negative affect were associated with later-day smoking urges, and morning negative affect was related to later-day smoking behavior. Future research should examine whether interventions that boost positive affect on mornings when it is lower than usual and attenuate negative affect on mornings when it is higher than usual, may reduce the intensity of smoking urges and the likelihood of smoking later in the day. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Patient Engagement and Provider Effectiveness of a Novel Sleep Telehealth Platform and Remote Monitoring Assessment in the US Military: Pilot Study Providing Evidence-Based Sleep Treatment Recommendations.

BACKGROUND: Sleep problems are common and costly in the US military. Yet, within the military health system, there is a gross shortage of trained specialist providers to address sleep problems. As a result, demand for sleep medicine care far exceeds the available supply. Telehealth including telemedicine, mobile health, and wearables represents promising approaches to increase access to high-quality and cost-effective care. OBJECTIVE: The purpose of this study was to evaluate patient engagement and provider perceived effectiveness of a novel sleep telehealth platform and remote monitoring assessment in the US military. The platform includes a desktop web portal, native mobile app, and integrated wearable sensors (ie, a commercial off-the-shelf sleep tracker [Fitbit]). The goal of the remote monitoring assessment was to provide evidence-based sleep treatment recommendations to patients and providers. METHODS: Patients with sleep problems were recruited from the Internal Medicine clinic at Walter Reed National Military Medical Center. Patients completed intensive remote monitoring assessments over 10 days (including a baseline intake questionnaire, daily sleep diaries, and 2 daily symptom surveys), and wore a Fitbit sleep tracker. Following the remote monitoring period, patients received assessment results and personalized sleep education in the mobile app. In parallel, providers received a provisional patient assessment report in an editable electronic document format. Patient engagement was assessed via behavioral adherence metrics that were determined a priori. Patients also completed a brief survey regarding ease of completion. Provider effectiveness was assessed via an anonymous survey. RESULTS: In total, 35 patients with sleep problems participated in the study. There were no dropouts. Results indicated a high level of engagement with the sleep telehealth platform, with all participants having completed the baseline remote assessment, reviewed their personalized sleep assessment report, and completed the satisfaction survey. Patients completed 95.1% of sleep diaries and 95.3% of symptom surveys over 10 days. Patients reported high levels of satisfaction with most aspects of the remote monitoring assessment. In total, 24 primary care providers also participated and completed the anonymous survey. The results indicate high levels of perceived effectiveness and identified important potential benefits from adopting a sleep telehealth approach throughout the US military health care system. CONCLUSIONS: Military patients with sleep problems and military primary care providers demonstrated high levels of engagement and satisfaction with a novel sleep telehealth platform and remote monitoring assessment. Sleep telehealth approaches represent a potential pathway to increase access to evidence-based sleep medicine care in the US military. Further evaluation is warranted.

Substitutability of menthol cigarette alternatives: a clinical trial.

INTRODUCTION: This study assessed the substitutability of plausible combustible menthol cigarette alternatives (MCAs) for usual brand menthol cigarettes (UBMCs) in adults who smoke menthol cigarettes. METHODS: Following three in-lab sampling sessions, 80 adults aged 21-50 who smoke menthol cigarettes chose their preferred MCA: (1) a menthol roll-your-own cigarette (mRYO), (2) a menthol filtered little cigar (mFLC) or (3) a non-menthol cigarette (NMC). Participants were instructed to completely substitute their preferred MCA for their UBMC for 1 week and complete daily diaries documenting adherence and subjective effects. At the final lab visit, participants completed concurrent choice and cross-price elasticity tasks with their substitute product and UBMC as the comparator. RESULTS: Most (65%) participants chose mRYO as their preferred product, followed by NMC and mFLC. Adherence to MCA was high for all products across the week (range: 63%-88%). Positive subjective effects for mRYO decreased over time but remained numerically higher than the other MCA products; craving reduction also decreased for NMC across phases. In the progressive ratio task, participants chose their UBMC in 61.7% of choices; this did not differ by preferred MCA, although the median breakpoint was highest for mRYO and similar for mFLC and NMC. Cross-price elasticity comparing UBMC and the preferred product indicated high substitutability of each MCA at phase 3 (I values -0.70 to -0.82). CONCLUSIONS AND RELEVANCE: mRYOs were the most preferred MCA among the study products, but all MCAs were acceptable substitutes for UBMC using behavioural and economic measures in a short-term trial period.Trial registration number NCT04844762.

Varenicline Combined With Oral Nicotine Replacement Therapy and Smartphone-Based Medication Reminders for Smoking Cessation: Feasibility Randomized Controlled Trial.

BACKGROUND: Varenicline and oral nicotine replacement therapy (NRT) have each been shown to increase the likelihood of smoking cessation, but their combination has not been studied. In addition, smoking cessation medication adherence is often poor, thus, challenging the ability to evaluate medication efficacy. OBJECTIVE: This study examined the effects of combined varenicline and oral NRT and smartphone medication reminders on pharmacotherapy adherence and smoking abstinence among adults enrolled in smoking cessation treatment. METHODS: A 2×2 factorial design was used. Participants (N=34) were randomized to (1) varenicline + oral NRT (VAR+NRT) or varenicline alone (VAR) and (2) smartphone medication reminder messages (REM) or no reminder messages (NREM) over 13 weeks. Participants assigned to VAR+REM received varenicline reminder prompts, and those assigned to VAR+NRT+REM also received reminders to use oral NRT. The other 2 groups (VAR+NREM and VAR+NRT+NREM) did not receive medication reminders. Participants were not blinded to intervention groups. All participants received tobacco cessation counseling. Smartphone assessments of smoking as well as varenicline and NRT use (if applicable) were prompted daily through the first 12 weeks after a scheduled quit date. Descriptive statistics were generated to characterize the relations between medication and reminder group assignments with daily smoking, daily varenicline adherence, and daily quantity of oral NRT used. Participants completed follow-up assessments for 26 weeks after the quit date. RESULTS: Participants were predominantly White (71%), and half were female (50%). On average, participants were 54.2 (SD 9.4) years of age, they smoked an average of 19.0 (SD 9.0) cigarettes per day and had smoked for 34.6 (SD 12.7) years. Descriptively, participants assigned to VAR+NRT reported more days of smoking abstinence compared to VAR (29.3 vs 26.3 days). Participants assigned to REM reported more days of smoking abstinence than those assigned to NREM (40.5 vs 21.8 days). Participants assigned to REM were adherent to varenicline on more days compared to those assigned to NREM (58.6 vs 40.5 days), and participants assigned to VAR were adherent to varenicline on more days than those assigned to VAR + NRT (50.7 vs 43.3 days). In the subsample of participants assigned to VAR+NRT, participants assigned to REM reported more days where ≥5 pieces of NRT were used than NREM (14.0 vs 7.4 days). Average overall medication adherence (assessed via the Medication Adherence Questionnaire) showed the same pattern as the daily smartphone-based adherence assessments. CONCLUSIONS: Preliminary findings indicated that smoking cessation interventions may benefit from incorporating medication reminders and combining varenicline with oral NRT, though combining medications may be associated with poorer adherence. Further study is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT03722966; https://classic.clinicaltrials.gov/ct2/show/NCT03722966.

mHealth Intervention for Vietnamese Living With Diabetes: Protocol for a Stepped Wedge Pilot Study.

BACKGROUND: Evidence indicates participation in a diabetes self-management education and support program improves self-care behaviors and hemoglobin A1c. Language and cultural differences may be barriers to program participation resulting in ineffective self-management, but these factors can be addressed with appropriate interventions. Given the high health care costs associated with diabetes complications, we developed a multicomponent, culturally tailored Self-Management Mobile Health Intervention for US Vietnamese With Diabetes (SMart-D). OBJECTIVE: This study aims to evaluate the SMart-D intervention's feasibility, acceptability, and effectiveness with intentions to scale up the intervention in the future. This mixed methods study incorporates the Reach, Effectiveness, Adoption, Implementation, Maintenance framework to evaluate the intervention. METHODS: This stepped wedge randomized controlled pilot study will be conducted over 2 years in collaboration with primary care clinics. Eligible participants are patients with type 2 diabetes who are receiving health care from participating clinics. Clinics will be randomly assigned to an implementation date and will begin with patients enrolling in the control period while receiving standard care, then cross over to the intervention period where patients receive standard care plus the SMart-D intervention for over 12 weeks. Focus groups or interviews will be conducted with clinicians and patients after study completion. Qualitative data will be analyzed using NVivo. Outcomes on self-care behavior changes will be measured with the Summary of Diabetes Self-Care Activities scale and clinical changes will be measured using laboratory tests. A generalized linear mixed-effect model will be used to compute time effect, clustering effect, and the interaction of the control and intervention periods using SAS (version 9.4; SAS Institute). RESULTS: We hypothesize that (1) at least 50% (n=5) of eligible clinics and 50% (n=40) of eligible patients who are invited will participate, and at least 70% (n=56) of patients will complete the program, and (2) patients who receive the intervention will have improved self-care behaviors and clinical test results with at least 75% (n=60) of the patients maintaining improved outcomes at follow-up visits compared with baseline, and participants will verbalize that the intervention is feasible and acceptable. As of August 2023, we enrolled 10 clinics and 60 patients. Baseline data results will be available by the end of 2023 and outcome data will be published in 2025. CONCLUSIONS: This is the first Vietnamese diabetes self-management education and support intervention that leverages mobile health technology to address the barriers of language and culture differences through collaboration with primary care clinics. This study will provide a better understanding of the implementation process, demonstrate the potential effectiveness of the intervention, accelerate the pace of moving evidence-based interventions to practice among the US Vietnamese population, and potentially provide a replicable implementation model that can be culturally adapted to other non-English speaking ethnic minorities. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48585.

Comparison of the Bluetooth iCOquit, piCO, and Vitalograph for the assessment of breath carbon monoxide among adults initiating smoking cessation and standardized canisters.

BACKGROUND: The Bluetooth iCOquit enables remote biochemical verification of smoking status, but its validity among adults attempting to quit smoking is unclear. This study 1) compared the iCOquit, piCO, and Vitalograph sensors to identify device-specific bias, 2) assessed the diagnostic accuracy of the iCOquit for the overall sample and within specific subgroups (sex, race, smoking rate, menthol use), and 3) assessed the validity of iCOquit readings against standardized CO canisters. METHODS: iCOquit devices were tested with human breath samples from individuals seeking treatment for combustible tobacco use (N = 93) attending an in-person clinic visit. Participants provided breath samples via the iCOquit, piCO, and Vitalograph (order randomized). iCOquit devices were also tested using 5 and 10 parts per million (ppm) canisters. RESULTS: The iCOquit underestimated CO and categorized more participants as abstinent relative to the other CO sensors with human breath samples. The results suggested the iCOquit could not be used interchangeably with the other CO devices. Using a cut-off of < 6 ppm, the diagnostic accuracy of the iCOquit (specificity = 94%; sensitivity = 85%) did not vary across demographic/smoking subgroups. Canister tests with the iCOquit suggested good precision (< 1 ppm). CONCLUSIONS: The iCOquit is an affordable option for the remote measurement of CO that provides a reasonably accurate assessment of smoking status of those attempting to quit smoking using abstinence cut-off criteria of < 6 ppm. However, compared to other CO monitors, the iCOquit may underestimate CO, thereby increasing error in assessing abstinence.