Review of strategies to investigate low sample return rates in remote tobacco trials: A call to action for more user-centered design research.

Remote collection of biomarkers of tobacco use in clinical trials poses significant challenges. A recent meta-analysis and scoping review of the smoking cessation literature indicated that sample return rates are low and that new methods are needed to investigate the underlying causes of these low rates. In this paper we conducted a narrative review and heuristic analysis of the different human factors approaches reported to evaluate and/or improve sample return rates among 31 smoking cessation studies recently identified in the literature. We created a heuristic metric (with scores from 0 to 4) to evaluate the level of elaboration or complexity of the user-centered design strategy reported by researchers. Our review of the literature identified five types of challenges typically encountered by researchers (in that order): usability and procedural, technical (device related), sample contamination (e.g., polytobacco), psychosocial factors (e.g., digital divide), and motivational factors. Our review of strategies indicated that 35% of the studies employed user-centered design methods with the remaining studies relying on informal methods. Among the studies that employed user-centered design methods, only 6% reached a level of 3 in our user-centered design heuristic metric. None of the studies reached the highest level of complexity (i.e., 4). This review examined these findings in the context of the larger literature, discussed the need to address the role of health equity factors more directly, and concluded with a call to action to increase the application and reporting of user-centered design strategies in biomarkers research.

Stagnant daily smoking prevalence between 2008 and 2019 among Black and Hispanic adults with serious psychological distress.

BACKGROUND: Racial/ethnic minority status and mental illness independently drive inequity in cigarette smoking and related morbidity. Racial/ethnic minority groups suffer a disproportionate burden of tobacco-related diseases. People with serious mental illness (SMI) smoke at up to 7 times the rate of the general population. There is a need to quantify smoking prevalence and trends among people at the intersection of both groups. METHODS: This study analyzes 2008-2019 data from the National Survey on Drug Use and Health. Linear time trends of daily smoking prevalence were assessed among people with serious psychological distress (SPD; marker for SMI) and people without SPD reporting White, Black, Hispanic, and Other race/ethnicity using logistic regression, with survey year as the predictor. Models with year-by-smoking status interaction terms and F-tests assessed differential time trends. RESULTS: The prevalence of daily smoking among people without SPD decreased over time among people reporting White (aOR=0.96, p<0.001), Black (aOR=0.96, p<0.001), Hispanic (aOR=0.95, p<0.001), and Other (aOR=0.97, p=0.002) race/ethnicity. Among people with SPD, the smoking prevalence decreased among people with White race/ethnicity (aOR=0.95, p<0.001), with no significant changes among people of Black, Hispanic, and Other race/ethnicity. CONCLUSIONS: Smoking among people with SPD who report Black and Hispanic race/ethnicity has not changed significantly in the past 11 years, despite decreasing among non-SPD and White groups. People who are Black/Hispanic and people with SPD struggle to quit smoking, which is amplified intersectionally. Tailored interventions may be a better mechanism to reduce barriers to smoking cessation in this population.

The Impact of the COVID-19 Pandemic on Stress, Isolation, Smoking Behaviors, and Motivation to Quit in People with HIV Who Smoke.

People with HIV (PWH) smoke at higher rates compared with the general population and have lower cessation rates. The primary aim of this study was to examine the impact of the COVID-19 pandemic on smoking in PWH. A survey was administered to participants in two smoking cessation trials in the United States. Mean cigarettes per day was 13.9 (SD 8.6), and participants reported they had smoked on average for 30.93 years (SD 10.4). More than half (55.7%) of participants (N = 140) reported not changing their smoking during the pandemic, while 15% reported decreasing, and 25% reported increasing their smoking. In bivariate analyses, worrying about food due to lack of money (χ2 = 9.13, df 2, p = 0.01) and greater Covid-related worry (rs = 0.19, p = 0.02) were significantly associated with increased smoking. Qualitative research may be needed to more clearly elucidate factors related to smoking behaviors among PWH.

An examination of neurocognition and theory of mind as predictors of engagement with a tailored digital therapeutic in persons with serious mental illness.

There is an increasing interest in the development and implementation of digital therapeutics (apps) in individuals with serious mental illness (SMI). However, there is limited understanding of the role of neurocognition and social cognition on engagement with apps. The present study is a secondary analysis of a pilot randomized controlled trial (N = 62) comparing a tailored digital intervention to treat tobacco use disorder in individuals with SMI to a standard of care digital intervention for the general population. The purpose of this study was to examine the impact of neurocognition, social cognition, and clinical characteristics on indices of app engagement in users of the tailored app compared to users of the standard of care app. Correlational analyses demonstrated that individuals with low levels of neurocognition and social cognition engaged more often and for longer duration with the tailored app compared to the standard of care app. In a series of multilevel zero-inflated negative binomial models, assignment to the tailored app remained the most robust predictor of app interactions (Risk Ratio [RR] = 1.72; p < .01), duration of app use (RR = 6.47; p < .01), and average length of interaction (RR = 2.70; p < .01), after adjusting for key demographic and clinical characteristics, and two measures of cognition. This is one of the first studies to demonstrate that digital therapeutics can be designed to mitigate the impact of neurocognition and social cognition on device engagement in SMI populations. Recommendations are made to advance the use of new analytic models to uncover patterns of engagement with digital therapeutics.

Engagement with a digital therapeutic for smoking cessation designed for persons with psychiatric illness fully mediates smoking outcomes in a pilot randomized controlled trial.

Understanding the mechanisms of change of digital therapeutics is a critical step to improve digital health outcomes and optimize their development. Access to and engagement with digital content is arguably a core mechanism of change of these interventions. However, the mediational role of app engagement has been largely unexamined. To evaluate the mediational effect of engaging with a digital therapeutic for smoking cessation designed for adults with psychiatric disorders. Secondary analysis of a pilot clinical trial of 62 adults with serious mental illness who were randomized to receive either a tailored digital therapeutic (Learn to Quit) or a digital therapeutic for the general public (NCI QuitGuide). Engagement was captured using background analytics of app utilization, including (a) number of interactions with app content, (b) minutes/day of app use, and (c) number of days used. The main outcome was reductions in cigarettes per day from baseline to the four-month endpoint. Mediational analysis followed the Preacher and Hayes bootstrap method. Number of application interactions fully mediated reductions in cigarettes per day in the Learn to Quit application but not in QuitGuide (Average Causal Mediation Effect = .31, p = .02). Minutes/day of app use played an uncertain role, and number of days used was not a significant mediator. Results suggest that one of the mechanisms of action of the Learn to Quit device, engagement with theory-based content, functioned as intended. Future research of digital therapeutics should emphasize granular approaches to evaluating apps' mechanisms of action.

Usability and Acceptability of Two Smartphone Apps for Smoking Cessation Among Young Adults With Serious Mental Illness: Mixed Methods Study.

BACKGROUND: Young adults with serious mental illness (SMI) have higher smoking rates and lower cessation rates than young adults without SMI. Scalable interventions such as smartphone apps with evidence-based content (eg, the National Cancer Institute's [NCI's] QuitGuide and quitSTART) could increase access to potentially appealing and effective treatment for this group but have yet to be tested in this population. OBJECTIVE: The goal of this user-centered design study is to determine the user experience (including usability and acceptability) of 2 widely available apps developed by the NCI-QuitGuide and quitSTART-among young adult tobacco users with SMI. METHODS: We conducted usability and acceptability testing of QuitGuide and quitSTART among participants with SMI aged between 18 and 35 years who were stable in community mental health treatment between 2019 and 2020. Participants were randomly assigned to use QuitGuide or quitSTART on their smartphones. App usability was evaluated at baseline and following a 2-week field test of independent use via a video-recorded task completion protocol. Using a mixed method approach, we triangulated 4 data sources: nonparticipant observation, open-ended interviews, structured interviews (including the System Usability Scale [SUS]), and backend app use data obtained from the NCI. Quantitative data were analyzed using descriptive statistics, and qualitative data were analyzed using thematic analysis. RESULTS: Participants were 17 smokers who were not interested in quitting, with a mean age of 29 (SD 4) years; 41% (n=7) presented with psychotic disorders. Participants smoked an average of 15 (SD 7) cigarettes per day. The mean SUS scores for QuitGuide were similar at visits one and two (mean 64, SD 18 and mean 66, SD 18, respectively). The mean SUS scores for quitSTART numerically increased from visit one (mean 55, SD 20) to visit two (mean 64, SD 16). Acceptability scores followed the same pattern. Observed task completion rates were at least 75% (7/9 for QuitGuide, 6/8 for quitSTART) for both apps at both visits for all but 2 tasks. During the 13-day trial period, QuitGuide and quitSTART users interacted with their assigned app on an average of 4.6 (SD 2.8) days versus 10.8 (SD 3.5) days, for a mean total of 5.6 (SD 3.8) interactions versus 41 (SD 26) interactions, and responded to a median of 1 notification (range 0-8) versus 18.5 notifications (range 0-37), respectively. Qualitative comments indicated moderate to high satisfaction overall but also included concerns about the accuracy of the apps' feedback. CONCLUSIONS: Both QuitGuide and quitSTART had acceptable levels of usability and mixed levels of acceptability among young adults with SMI. The higher level of engagement with quitSTART suggests that quitSTART may be a favorable tool for young adult smokers with SMI. However, clinical support or coaching may be needed to overcome initial usability issues.

The United States National Cancer Institute's Coordinated Research Effort on Tobacco Use as a Major Cause of Morbidity and Mortality among People with HIV.

The use of antiretroviral therapy for people with HIV (PWH) has improved life expectancy. However, PWH now lose more life-years to tobacco use than to HIV infection. Unfortunately, PWH smoke at higher rates and have more difficulty maintaining abstinence than the general population, compounding their risk for chronic disease. In this Commentary, we describe a United States National Cancer Institute-led initiative to address the relative lack of research focused on developing, testing, and implementing smoking cessation interventions for PWH. This initiative supports seven clinical trials designed to systematically test and/or develop and test adaptations of evidence-based smoking cessation interventions for PWH (eg, combination of behavioral and pharmacological). We summarize each project, including setting/recruitment sites, inclusion/exclusion criteria, interventions being tested, and outcomes. This initiative provides critical opportunities for collaboration and data harmonization across projects. The knowledge gained will inform strategies to assist PWH to promote and maintain abstinence, and ensure that these efforts are adaptable and scalable, thereby addressing one of the major threats to the health of PWH. Reducing smoking behavior may be particularly important during the COVID-19 pandemic given that smokers who become infected with SARS-CoV-2 may be at risk for more severe disease. IMPLICATIONS: This Commentary describes a National Cancer Institute-led initiative to advance the science and practice of treating tobacco use among PWH, which is now responsible for more life years lost than HIV. We describe the scope of the problem, the objectives of the initiative, and a summary of the seven funded studies. Harmonization of data across projects will provide information related to treatment mediators and moderators that was not previously possible. Stakeholders interested in tobacco cessation, including researchers, clinicians and public health officials, should be aware of this initiative and the evidence-base it will generate to advance tobacco treatment among this high-risk population.

Theoretical Grounds of Pain Tracker Self Manager: An Acceptance and Commitment Therapy Digital Intervention for Patients with Chronic Pain.

OBJECTIVE: To report the theoretical basis and design of a novel digital Acceptance and Commitment Therapy (ACT) intervention for people with chronic pain, the Pain Tracker Self Manager (PTSM), which had promising efficacy in a recent pilot trial. METHODS: Content development by a multidisciplinary panel of experts in psychiatry, clinical psychology, nursing and social work, with feedback from a group of patients with chronic pain and their providers. Materials included paper-based sketching of a story character, visual metaphors, and a series of stories designed to deliver the theory-based components of our behavioral intervention. RESULTS: This development and design process resulted in 4 digitally delivered clinical modules that combine visual and verbal cues. In addition, it generated a series of novel ACT metaphors specifically tailored to patients with chronic pain: Pain: Injury vs. Threat, Life Navigation System, The Fog of Pain, and Get Rhythm. Consistent with ACT theory and the contextual behavioral science framework, PTSM utilized: perspective-taking, values clarification, acceptance strategies, and nursing and psychological care recommendations. DISCUSSION: Reports of the design and theoretical basis of digital health interventions are highly needed to increase the rigor of their development process and more progressively advance our body of knowledge. This pilot study developed and tested a series of ACT metaphors that can be readily used by ACT clinicians working with this population. CONCLUSION: PTSM is a novel digital ACT intervention for patients with chronic pain with features directly linked to ACT processes and theory.

Review of Popularity and Quality Standards of Opioid-Related Smartphone Apps.

PURPOSE OF REVIEW: Opioid misuse, addiction, and related harm is a global crisis that affects public health and social and economic welfare. Many of the strategies being used to combat the opioid crisis could benefit from improved access and dissemination, such as that afforded by smartphone apps. The goal of this study was to characterize the purpose, audience, quality and popularity of opioid-related smartphone apps. Using web scraping, available information from 619 opioid-related apps (e.g., popularity metrics) was downloaded from Google Play, and 59 apps met criteria for review. The apps were additionally coded for quality by two raters using an 8-item screener for the American Psychiatric Association App Evaluation Model. FINDINGS: Sixty one percent of apps targeted patients, 29% providers, 8% the general community, and 2% healthcare trainees. Regarding app purpose, 49% addressed treatment, 27% prevention, and 24% overdose. Only one app met all criteria on the screener for quality, and there was no association between a total score calculated for the screener and measures of app popularity (e.g., star ratings; R2=0.10, p=0.19). SUMMARY: Opioid-related apps available for consumers addressed key stakeholders (patients, providers, community) and were consistent with strategies to address the opioid crisis (prevention, treatment, overdose). However, there was little evidence that available opioid-related apps meet basic quality standards, and no relationship was found between app quality and popularity. This review was conducted at the level of consumer decision-making (i.e., the app store), where only a handful of opioid-related apps met quality standards enough to warrant a more detailed evaluation of the app before recommendation for use. Because smartphone apps could be a critical tool to increase access to and utilization of opioid prevention, treatment, and recovery services, further development and testing is sorely needed.

Pilot Randomized Controlled Trial of a Novel Smoking Cessation App Designed for Individuals With Co-Occurring Tobacco Use Disorder and Serious Mental Illness.

INTRODUCTION: High rates of tobacco use among people with serious mental illness (SMI), along with their unique needs, suggest the importance of developing tailored smoking cessation interventions for this group. Previous early-phase work empirically validated the design and content of Learn to Quit, a theory-based app designed for this population. METHODS: In a pilot randomized controlled trial, we compared the feasibility, acceptability, and preliminary efficacy of Learn to Quit versus QuitGuide, an app designed for the general population. All participants received nicotine replacement therapy and technical assistance. Daily smokers with SMI (N = 62) participated in the trial with outcomes assessed at weeks 4, 8, 12, and 16. RESULTS: Compared to QuitGuide, Learn to Quit participants had similar number of days of app use (34 vs. 32, p = .754), but larger number of app interactions (335 vs. 205; p = .001), longer durations of app use (4.24 hrs. vs. 2.14 hrs; p = .044), and higher usability scores (85 vs. 79, p = .046). At week 16, Learn to Quit led to greater reductions in cigarettes per day (12.3 vs. 5.9 for QuitGuide; p = 0.10). Thirty-day point prevalence abstinence was verified in 12% of Learn to Quit participants versus 3% of QuitGuide participants (odds ratio = 3.86, confidence interval = 0.41 to 36, p = .239). Changes in psychiatric symptoms and adverse events were not clinically significant between conditions. CONCLUSIONS: This pilot trial provides strong evidence of Learn to Quit's usability, feasibility, and safety. Preliminary evidence suggests the app may be efficacious. A randomized controlled efficacy trial is needed to test the app in a larger sample of smokers with SMI. IMPLICATIONS: This study suggests that the Learn to Quit app is a feasible approach to deliver smoking cessation treatment in patients with co-occurring tobacco use disorder and SMI. This means that, if found efficacious, this technology could be used to deploy smoking cessation treatment to larger segments of this population, hence improving public health. Therefore, a randomized controlled trial should be conducted to examine the efficacy of this digital intervention.

Formative, multimethod case studies of learn to quit, an acceptance and commitment therapy smoking cessation app designed for people with serious mental illness.

Despite public health efforts, individuals with serious mental illness (SMI) still have very high rates of tobacco smoking. Innovative approaches to reach this population are needed. These series of case studies aimed to descriptively evaluate the usability, user experience (UX), and user engagement (UE) of Learn to Quit (LTQ), an acceptance and commitment therapy smoking cessation app designed for people with SMI, and to compare it with an app designed for the general population, NCI (National Cancer Institute) QuitGuide (QG). Both apps were combined with nicotine replacement therapy and technical coaching. Inspired by the ORBIT model, we implemented two case studies with crossover AB interventions, two B-phase training designs, and three bi-phasic AB single-case designs with Start-Point and Order randomization (A = QG, B = LTQ). Study outcomes were measured using the System Usability Scale, UX interviews, and background analytics. LTQ's usability levels were above the standard cutoff and on average higher than QG. UX outcomes suggested the relative benefits of LTQ's visual design, gamification and simple design structure. LTQ's overall UE was high; the app was opened for an average of 14 min per day (vs. QG: 7 min). However, users showed low levels of UE with each of the app's tracking feature. Measures of psychiatric functioning suggested the safety of LTQ in people with SMI. LTQ appears to be a usable and engaging smoking cessation app in people with SMI. An optimized version of LTQ should be tested in a Phase II study.

Mobile Applications for the Treatment of Tobacco Use and Dependence.

PURPOSE OF REVIEW: Smoking remains a leading preventable cause of premature death in the world; thus, developing effective and scalable smoking cessation interventions is crucial. This review uses the Obesity-Related Behavioral Intervention Trials (ORBIT) model for early phase development of behavioral interventions to conceptually organize the state of research of mobile applications (apps) for smoking cessation, briefly highlight their technical and theory-based components, and describe available data on efficacy and effectiveness. RECENT FINDINGS: Our review suggests that there is a need for more programmatic efforts in the development of mobile applications for smoking cessation, though it is promising that more studies are reporting early phase research such as user-centered design. We identified and described the app features used to implement smoking cessation interventions, and found that the majority of the apps studied used a limited number of mechanisms of intervention delivery, though more effort is needed to link specific app features with clinical outcomes. Similar to earlier reviews, we found that few apps have yet been tested in large well-controlled clinical trials, although progress is being made in reporting transparency with protocol papers and clinical trial registration. SUMMARY: ORBIT is an effective model to summarize and guide research on smartphone apps for smoking cessation. Continued improvements in early phase research and app design should accelerate the progress of research in mobile apps for smoking cessation.

Is shame a proximal trigger for drinking? A daily process study with a community sample.

Between-subjects studies show that people with higher levels of shame tend to experience more negative drinking-related consequences than people with lower levels of shame. However, within-subjects studies of the association between daily fluctuations in shame and subsequent drinking have yielded mixed findings. This study aimed to resolve these inconsistencies by examining the association between daily fluctuations in shame, between-subjects differences in shame, and subsequent evening alcohol consumption in a sample of 70 community-dwelling drinkers. In addition, we examined whether the previous night's drinking predicted shame the next day based on the theory that shame may operate in a cyclical fashion in some people to maintain problematic drinking patterns. Multilevel model analyses showed a cross-level interaction in which individuals' average levels of ashamed mood moderated the effect of daily fluctuations in shame on solitary drinking. In contrast, previous day's drinking was only weakly related to shame the next day. This study contributes to existing literature by refining models of negative mood-related drinking and further elucidating the patterns by which shame serves as a trigger for drinking, particularly among high shame individuals. The authors interpret results in terms of self-control theory and demonstrate the importance of disaggregating between- and within-subjects variance when examining longitudinal data. (PsycINFO Database Record

A Controlled Pilot Trial of PainTracker Self-Manager, a Web-Based Platform Combined With Patient Coaching, to Support Patients' Self-Management of Chronic Pain.

The objective of this study was to develop and pilot test a chronic pain empowerment and self-management platform, derived from acceptance and commitment therapy, in a pain specialty setting. A controlled, sequential, nonrandomized study design was used to accommodate intervention development and to test the efficacy of the PainTracker Self-Manager (PTSM) intervention (Web-based educational modules and outcome tracking combined with tailored patient coaching sessions and provider guidance). Generalized estimating equations evaluated changes over time (baseline, 3 months, 6 months) in pain self-efficacy (primary outcome), chronic pain acceptance (activity engagement and pain willingness), perceived efficacy in patient-provider interactions, pain intensity and interference, and overall satisfaction with pain treatment (secondary outcomes) between intervention (n = 48) and usual care control groups (n = 51). The full study sample (N = 99) showed greater improvements over time (significant Group × Time interactions) in pain self-efficacy and satisfaction with pain treatment. Among study completers (n = 82), greater improvement in activity engagement as well as pain intensity and interference were also observed. These preliminary findings support the efficacy of the PTSM intervention in a pain specialty setting. Further research is needed to refine and expand the PTSM intervention and to test it in a randomized trial in primary care settings. PERSPECTIVE: We developed a Web-based patient empowerment platform that combined acceptance and commitment therapy-based educational modules and tailored coaching sessions with longitudinal tracking of treatments and patient-reported outcomes, named PTSM. Pilot controlled trial results provide preliminary support for its efficacy in improving pain self-efficacy, activity engagement, pain intensity and interference, and satisfaction with pain treatment.

User-Centered Design of Learn to Quit, a Smoking Cessation Smartphone App for People With Serious Mental Illness.

BACKGROUND: Smoking rates in the United States have been reduced in the past decades to 15% of the general population. However, up to 88% of people with psychiatric symptoms still smoke, leading to high rates of disease and mortality. Therefore, there is a great need to develop smoking cessation interventions that have adequate levels of usability and can reach this population. OBJECTIVE: The objective of this study was to report the rationale, ideation, design, user research, and final specifications of a novel smoking cessation app for people with serious mental illness (SMI) that will be tested in a feasibility trial. METHODS: We used a variety of user-centered design methods and materials to develop the tailored smoking cessation app. This included expert panel guidance, a set of design principles and theory-based smoking cessation content, development of personas and paper prototyping, usability testing of the app prototype, establishment of app's core vision and design specification, and collaboration with a software development company. RESULTS: We developed Learn to Quit, a smoking cessation app designed and tailored to individuals with SMI that incorporates the following: (1) evidence-based smoking cessation content from Acceptance and Commitment Therapy and US Clinical Practice Guidelines for smoking cessation aimed at providing skills for quitting while addressing mental health symptoms, (2) a set of behavioral principles to increase retention and comprehension of smoking cessation content, (3) a gamification component to encourage and sustain app engagement during a 14-day period, (4) an app structure and layout designed to minimize usability errors in people with SMI, and (5) a set of stories and visuals that communicate smoking cessation concepts and skills in simple terms. CONCLUSIONS: Despite its increasing importance, the design and development of mHealth technology is typically underreported, hampering scientific innovation. This report describes the systematic development of the first smoking cessation app tailored to people with SMI, a population with very high rates of nicotine addiction, and offers new design strategies to engage this population. mHealth developers in smoking cessation and related fields could benefit from a design strategy that capitalizes on the role visual engagement, storytelling, and the systematic application of behavior analytic principles to deliver evidence-based content.

What Do Smokers Want in A Smartphone-Based Cessation Application?

Background: Fueled by rapid technological advances over the past decade, there is growing interest in the use of smartphones to aid in smoking cessation. Hundreds of applications have been developed for this purpose, but little is known about how these applications are accessed and used by smokers or what features smokers believe would be most useful. Purpose: The present study sought to understand the prevalence of smartphone ownership and patterns of use among smokers as well as the perceived utility of various smartphone application features for smoking cessation that are currently in development or already available. Methods: Daily cigarette smokers (n = 224) reported on smartphone ownership, their patterns of smartphone usage, and perceived utility of features. Features were ranked according to perceived utility and differences in both perceived utility and general smartphone use patterns were examined as a function of demographic and smoking-related variables. Results: Most smokers (80.4%) own a smartphone, but experience with smoking cessation applications is extremely rare (6.1%). Ownership and patterns of usage differed as a function of demographic and smoking-related variables. Overall, gain-framed features were rated as most useful, while loss-framed and interpersonal features were rated as least useful. Conclusions: Mobile health interventions have the potential to reach a large number of smokers but are currently underutilized. Additional effort is needed to ensure parity in treatment access. Gain-framed messages may be especially useful for engaging smokers, even if other features ultimately drive treatment effects. Implications: This study describes patterns of smartphone usage among smokers and identifies the smartphone application features smokers believe would be most useful during a quit attempt. Findings indicate which subgroups of smokers are most likely to be reached with mobile health interventions and suggests that inclusion of specific features may be helpful for engaging smokers in the smoking cessation process.