Smartphone-Based Smoking Cessation Intervention (OKquit) for Oklahoma Tobacco Helpline Users: Protocol for a Randomized Controlled Trial.

BACKGROUND: Tobacco quitlines provide effective resources (eg, nicotine replacement therapy, smoking cessation counseling, and text and web-based support) for those who want to quit smoking in the United States. However, quitlines reach approximately only 1%-3% of people who smoke each year. Novel, smartphone-based, and low-burden interventions that offer 24/7 access to smoking cessation resources that are tailored to current readiness to quit may increase appeal, reach, and effectiveness of smoking cessation interventions. OBJECTIVE: This study will examine the efficacy of OKquit, a low-burden smartphone-based app for smoking cessation. METHODS: Approximately 500 people who smoke cigarettes and access the Oklahoma Tobacco Helpline (OTH) will be randomized to receive standard OTH care (SC) or SC plus the novel OKquit smartphone app for smoking cessation (OKquit). All participants will use a smartphone app to complete study surveys (ie, baseline, 27 weekly surveys, brief daily check-ins, and 27-week follow-up). Upon completion of daily check-ins and weekly surveys, participants will receive either trivia type messages (SC) or messages that are tailored to current readiness to quit smoking and currently experienced lapse triggers (OKquit). In addition, those assigned to receive the OKquit app will have access to on-demand smoking cessation content (eg, quit tips, smoking cessation medication tips). It is hypothesized that participants assigned to OKquit will be more likely to achieve biochemically verified 7-day point prevalence abstinence than those assigned to SC at 27 weeks post enrollment. In addition, participants who use more OTH resources (eg, more cessation coaching sessions completed) or more OKquit resources (eg, access more quit tips) will have greater biochemically verified smoking cessation rates. RESULTS: Data collection began in September 2022 and final follow-ups are expected to be completed by May 2025. CONCLUSIONS: Data from this randomized controlled trial will determine whether the OKquit smartphone app combined with OTH care will increase smoking cessation rates over standard OTH care alone. If successful, OKquit could provide tailored intervention content at a fraction of the cost of traditional interventions. Furthermore, this type of low-burden intervention may offer a way to reach underserved populations of adults who smoke and want to quit. TRIAL REGISTRATION: ClinicalTrials.gov NCT05539209; https://clinicaltrials.gov/study/NCT05539209. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56827.

Investigating Best Practices for Ecological Momentary Assessment: Nationwide Factorial Experiment.

BACKGROUND: Ecological momentary assessment (EMA) is a measurement methodology that involves the repeated collection of real-time data on participants' behavior and experience in their natural environment. While EMA allows researchers to gain valuable insights into dynamic behavioral processes, the need for frequent self-reporting can be burdensome and disruptive. Compliance with EMA protocols is important for accurate, unbiased sampling; yet, there is no "gold standard" for EMA study design to promote compliance. OBJECTIVE: The purpose of this study was to use a factorial design to identify optimal study design factors, or combinations of factors, for achieving the highest completion rates for smartphone-based EMAs. METHODS: Participants recruited from across the United States were randomized to 1 of 2 levels on each of 5 design factors in a 2×2×2×2×2 design (32 conditions): factor 1-number of questions per EMA survey (15 vs 25); factor 2-number of EMAs per day (2 vs 4); factor 3-EMA prompting schedule (random vs fixed times); factor 4-payment type (US $1 paid per EMA vs payment based on the percentage of EMAs completed); and factor 5-EMA response scale type (ie, slider-type response scale vs Likert-type response scale; this is the only within-person factor; each participant was randomized to complete slider- or Likert-type questions for the first 14 days or second 14 days of the study period). All participants were asked to complete prompted EMAs for 28 days. The effect of each factor on EMA completion was examined, as well as the effects of factor interactions on EMA completion. Finally, relations between demographic and socioenvironmental factors and EMA completion were examined. RESULTS: Participants (N=411) were aged 48.4 (SD 12.1) years; 75.7% (311/411) were female, 72.5% (298/411) were White, 18.0% (74/411) were Black or African American, 2.7% (11/411) were Asian, 1.5% (6/411) were American Indian or Alaska Native, 5.4% (22/411) belonged to more than one race, and 9.6% (38/396) were Hispanic/Latino. On average, participants completed 83.8% (28,948/34,552) of scheduled EMAs, and 96.6% (397/411) of participants completed the follow-up survey. Results indicated that there were no significant main effects of the design factors on compliance and no significant interactions. Analyses also indicated that older adults, those without a history of substance use problems, and those without current depression tended to complete more EMAs than their counterparts. No other demographic or socioenvironmental factors were related to EMA completion rates. Finally, the app was well liked (ie, system usability scale score=82.7), and there was a statistically significant positive association between liking the app and EMA compliance. CONCLUSIONS: Study results have broad implications for developing best practices guidelines for future studies that use EMA methodologies. TRIAL REGISTRATION: ClinicalTrials.gov number NCT05194228; https://clinicaltrials.gov/study/NCT05194228.

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.

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.

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.

The Prevalence and Perceived Utility of Mobile Health Technology Among Recently Incarcerated Homeless Adults.

Mobile technologies can deliver physical and mental health services for recently incarcerated homeless adults (RIHAs). The purpose of this study was to examine the prevalence and perceived utility of mobile technology to support health behavior change among RIHAs. Participants (n = 324) from an ongoing clinical trial at a homeless shelter in Texas were included in the current descriptive cross-sectional analyses. Over one fourth (28.4%) of participants had an active cell phone. Nearly 90 percent (88.6%) of participants reported at least weekly use of the internet, 77 percent used email (77.2%), and more than half used Facebook (55.2%). Although most participants (82.8%) believed that smartphone applications (apps) could help change their behavior, only a quarter (25.1%) had used an app for this purpose. These findings highlight the potential for smartphone-based intervention technologies, and future studies should examine whether smartphone apps that address mental health and health behaviors are feasible among RIHAs.

A Smartphone-Based Intervention for Anxiety and Depression in Racially and Ethnically Diverse Adults (EASE): Protocol for a Randomized Controlled Trial.

BACKGROUND: Clear health disparities have emerged in the rates of COVID-19 exposure, hospitalization, and death among Black, Hispanic, and American Indian (BHAI) individuals, relative to non-Hispanic White (NHW) individuals. BHAI populations have been disproportionately affected by lower behavioral health access and heightened negative mental health outcomes during the pandemic. OBJECTIVE: This project directly addresses health disparities in access to behavioral health care during the COVID-19 pandemic among BHAI populations via an adaptation of the established, initially validated, low-cost, mobile app Easing Anxiety Sensitivity for Everyone (EASE) among individuals with symptoms of elevated anxiety or depression or both. METHODS: The EASE trial is a 2-arm, prospective, randomized, blinded-assessor study with intention-to-treat analysis. Participants (N=800; n=200, 25%, Black; n=200, 25%, Hispanic; n=200, 25%, American Indian; and n=200, 25%, NHW) are randomized to receive either EASE or an active comparison condition for anxiety and depression. Participants compete an online prescreener, an enrollment call to provide informed consent, a baseline survey, a 6-month intervention period, and 3- and 6-month postbaseline assessments. Select participants also complete a 3- and 6-month postbaseline qualitative interview via phone or an online platform (eg, Zoom). Participants complete 2 scheduled daily ecological momentary assessments (EMAs) during the 6-month study period. These twice-daily EMAs guide a just-in-time approach to immediate, personalized behavioral health care. RESULTS: Outcomes include reductions in anxiety and depressive symptoms and functional impairment at 3 and 6 months postrandomization. We also will examine putative mechanisms (eg, anxiety sensitivity [AS] and COVID-19-specific stress and fear) of the intervention effects. Further, as treatment effects may differ across sociocultural factors, perceived discrimination, social support, and socioeconomic status (SES) will be evaluated as potential moderators of treatment effects on the primary outcomes. Process evaluation using data collected during the study, as well as individual interviews with participants, will complement quantitative data. CONCLUSIONS: Data from this efficacy trial will determine whether EASE successfully improves symptoms of anxiety and depression and whether these improvements outperform an active comparison control app. If successful, findings from this study have the potential to decrease anxiety and depression symptoms among vulnerable populations determined to be most at risk of exacerbated, long-lasting negative health sequelae. Data from this study may be used to support an implementation and dissemination trial of EASE within real-world behavioral health and social service settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT05074693; https://clinicaltrials.gov/ct2/show/NCT05074693. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40713.

The Utilization of a Rapid Agitation Scale and Treatment Protocol for Patient and Staff Safety in an Inpatient Psychiatric Setting.

Agitation is a common and potentially dangerous condition requiring rapid recognition and treatment in acute psychiatric units. Prompt intervention can prevent a patient with agitation from harming themselves, harming others, or needing restraints or seclusion. After the review of numerous guidelines, the Modified Agitation Severity Scale (MASS) agitation treatment protocol was developed to identify and manage agitation in an inpatient adult psychiatric setting. This protocol involved modifying an existing agitation scale and pairing scores with a treatment algorithm to indicate which behavioral and medication interventions would be most appropriate. All scoring and interventions were recorded in the electronic medical record (EMR). Three months of data were collected before and after the protocol was implemented. The new, modified scale had high reliability and correlated well with another validated agitation scale. Perceived patient safety was high during both study phases. Nurses' perceptions of safety trended upward after the protocol was implemented, though these differences were not significant, likely due to insufficient power. Although there was no decrease in seclusion events after implementation of the treatment protocol, there was a 44% decrease in restraint events and average restraint minutes per incident. Despite a potential increase in workload for nursing staff, implementation of the protocol did not increase burnout scores. Physicians continued to order the protocol for 55% of patients after the study period ended. These findings suggest that including a rapid agitation assessment and protocol within the EMR potentially improves nurses' perceptions of unit safety, helps assess treatment response, reduces time patients spend restrained, and supports decision making for nurses.

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

BACKGROUND: Black smokers have greater difficulty in quitting and higher rates of smoking-related diseases and disabilities than the general population. The smoking disparities experienced by this group are, in part, a consequence of multiple chronic life stressors (eg, racial discrimination) that engender increased exposure to interoceptive stress symptoms (eg, anxiety), which can ultimately lead to smoking as a means of immediate emotion regulation. OBJECTIVE: This study aimed to culturally adapt and initially test a novel mobile intervention (ie, Mobile Anxiety Sensitivity Program for Smoking [MASP]) that targets anxiety sensitivity (AS; a proxy for difficulty and responsivity to interoceptive stress) among Black smokers. The MASP intervention is culturally informed to address interoceptive stress management difficulties among Black smokers and is thus hypothesized to facilitate smoking cessation. METHODS: In phase 1, a total of 25 Black smokers with elevated AS will be administered MASP for 6 weeks. Following the completion of phase 1, we will further refine the MASP based on qualitative and quantitative data from participants to produce the final MASP iteration. In phase 2, a total of 200 Black smokers with elevated AS will be enrolled and randomly assigned to receive nicotine replacement therapy and either the smartphone-based National Cancer Institute QuitGuide app for standard mobile smoking cessation treatment or the MASP intervention. All participants in phases 1 and 2 will be enrolled remotely and will complete a web-based study screener; smartphone-based baseline assessment; daily smartphone-based ecological momentary assessments for 6 weeks; phone-based end-of-treatment qualitative interviews; and smartphone-based follow-up assessments at postbaseline weeks 1, 2 (quit date), 3, 4, 5, 6, 28, and 54 (weeks 28 and 54 follow-ups will be completed by phase 2 participants only). The MASP intervention is intended to offset barriers to treatment and encourage treatment engagement via smartphones. RESULTS: This project was funded in September 2020. Phase 1 data collection began in January 2022. Phase 2 data collection is scheduled to begin in July 2022. CONCLUSIONS: If successful, data from this study will support culturally informed treatment approaches for Black smokers and, pending findings of efficacy, provide an evidence-based mobile intervention for smoking cessation that is ready for dissemination and implementation. TRIAL REGISTRATION: ClinicalTrials.gov NCT04838236; https://clinicaltrials.gov/ct2/show/NCT04838236. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38905.

Conflicting Advice between Spiritual Leaders, Friends and Family, and Mental Health Providers: Impacts on Mental Health Treatment-Seeking Behaviors.

This study aimed to examine the effects of advice from religious/spiritual leaders and friends/family of a religious/spiritual person with mental health struggles on treatment-seeking. A survey was administered to adult patients of a university-affiliated psychiatric clinic in the Midwest. Participants whose friends/family members' advice conflicted with their psychiatrist's advice were six times more likely to delay seeking mental health treatment (OR: 6.09, 95% CI: 1.37, 27.01). Conflict between religious/spiritual leader's advice and psychiatrist's advice had a significant effect on delay in seeking mental health treatment (OR: 11.73, 95% CI: 2.21, 62.14), with an average delay of just over two years.

The impact of new guidelines on the prevalence of hypertension in children: A cross-sectional evaluation.

Updated clinical practice guidelines for screening blood pressures in pediatric patients were published in 2017. They differ from the previous guideline, known as the Fourth Report, providing updated population normal values and blood pressure categorization. We hypothesized that the prevalence of abnormal blood pressure in children and adolescents would be higher using the new clinical practice guidelines. We present a cross-sectional study of screening blood pressure values for children 3 to 18 years of age obtained during well-child visits at a primary care clinic. All blood pressure values were categorized using both the Fourth Report and the Clinical Practice Guideline. A total of 2635 blood pressure measurements were extracted, and 2600 were eligible for analysis. Using the clinical practice guideline, the prevalence of hypertension increased to 17.85% compared to 9.5% per the Fourth Report (P < 0.0001). Of those patients classified as having a normal blood pressure by the Fourth Report, 12% changed to abnormal when applying the Clinical Practice Guideline. All subgroups had a significant increase in the prevalence of abnormal blood pressure. The most dramatic increase in the prevalence of stage 1 and stage 2 hypertension was seen in six patient subgroups: males, 3-12 years of age, Hispanic ethnicity, race designated as other, normal weight, and overweight. Applying the new Clinical Practice Guideline increased the prevalence of elevated blood pressure and stage 1 and stage 2 hypertension in children and adolescents, requiring more follow-up and intervention than previously expected for this patient population.

Development and Evaluation of a Nutrition-Centered Lifestyle Medicine Curriculum for Physician Assistant Students.

BACKGROUND: US medical schools are increasingly integrating lifestyle medicine competencies into their academic programs. Yet, physician assistant (PA) academic programs have been slower to respond. METHODS: We developed, implemented, and evaluated a nutrition-centered lifestyle medicine curriculum for 2nd-year PA students (n = 24). The 4-week hybrid, 2-credit hour course activities aligned with the American College of Lifestyle Medicine competencies for primary care providers and reinforced four of the Accreditation Standards for PA Education. We combined didactic lectures with weekly hands-on cooking modules from the "Health meets Food" courseware for medical students. We employed a pre-post evaluation design including a comparison group of 2nd-year PA students in a separate program. We assessed changes in personal nutrition behaviors and knowledge and confidence for counseling in nutrition, exercise/physical activity, weight, smoking, and alcohol, using the modified 5A's framework (assess, advise, agree, assist, and arrange) for lifestyle counseling. RESULTS: Students receiving the intervention demonstrated significantly higher gains in both knowledge and confidence for the 5A's of nutrition counseling compared to the control group. Self-reported knowledge and confidence for the 5A's of counseling for the other lifestyle behaviors similarly improved among the intervention group compared to the control group, but to a lesser extent. CONCLUSION: A nutrition-centered lifestyle medicine course can demonstrate PA academic program adherence to accreditation standards, while also introducing students to nutrition and lifestyle medicine competencies. Hands-on experiences that reinforce didactic instruction may maximize student knowledge and self-efficacy for implementing lifestyle medicine into their practice.