Smartband-based smoking detection and real-time brief mindfulness intervention: findings from a feasibility clinical trial.

BACKGROUND: Smartbands can be used to detect cigarette smoking and deliver real time smoking interventions. Brief mindfulness interventions have been found to reduce smoking. OBJECTIVE: This single arm feasibility trial used a smartband to detect smoking and deliver brief mindfulness exercises. METHODS: Daily smokers who were motivated to reduce their smoking wore a smartband for 60 days. For 21 days, the smartband monitored, detected and notified the user of smoking in real time. After 21 days, a 'mindful smoking' exercise was triggered by detected smoking. After 28 days, a 'RAIN' (recognize, allow, investigate, nonidentify) exercise was delivered to predicted smoking. Participants received mindfulness exercises by text message and online mindfulness training. Feasibility measures included treatment fidelity, adherence and acceptability. RESULTS: Participants (N=155) were 54% female, 76% white non-Hispanic, and treatment starters (n=115) were analyzed. Treatment fidelity cutoffs were met, including for detecting smoking and delivering mindfulness exercises. Adherence was mixed, including moderate smartband use and low completion of mindfulness exercises. Acceptability was mixed, including high helpfulness ratings and mixed user experiences data. Retention of treatment starters was high (81.9%). CONCLUSIONS: Findings demonstrate the feasibility of using a smartband to track smoking and deliver quit smoking interventions contingent on smoking.

Parameter Space and Potential for Biomarker Development in 25 Years of fMRI Drug Cue Reactivity: A Systematic Review.

Importance: In the last 25 years, functional magnetic resonance imaging drug cue reactivity (FDCR) studies have characterized some core aspects in the neurobiology of drug addiction. However, no FDCR-derived biomarkers have been approved for treatment development or clinical adoption. Traversing this translational gap requires a systematic assessment of the FDCR literature evidence, its heterogeneity, and an evaluation of possible clinical uses of FDCR-derived biomarkers. Objective: To summarize the state of the field of FDCR, assess their potential for biomarker development, and outline a clear process for biomarker qualification to guide future research and validation efforts. Evidence Review: The PubMed and Medline databases were searched for every original FDCR investigation published from database inception until December 2022. Collected data covered study design, participant characteristics, FDCR task design, and whether each study provided evidence that might potentially help develop susceptibility, diagnostic, response, prognostic, predictive, or severity biomarkers for 1 or more addictive disorders. Findings: There were 415 FDCR studies published between 1998 and 2022. Most focused on nicotine (122 [29.6%]), alcohol (120 [29.2%]), or cocaine (46 [11.1%]), and most used visual cues (354 [85.3%]). Together, these studies recruited 19 311 participants, including 13 812 individuals with past or current substance use disorders. Most studies could potentially support biomarker development, including diagnostic (143 [32.7%]), treatment response (141 [32.3%]), severity (84 [19.2%]), prognostic (30 [6.9%]), predictive (25 [5.7%]), monitoring (12 [2.7%]), and susceptibility (2 [0.5%]) biomarkers. A total of 155 interventional studies used FDCR, mostly to investigate pharmacological (67 [43.2%]) or cognitive/behavioral (51 [32.9%]) interventions; 141 studies used FDCR as a response measure, of which 125 (88.7%) reported significant interventional FDCR alterations; and 25 studies used FDCR as an intervention outcome predictor, with 24 (96%) finding significant associations between FDCR markers and treatment outcomes. Conclusions and Relevance: Based on this systematic review and the proposed biomarker development framework, there is a pathway for the development and regulatory qualification of FDCR-based biomarkers of addiction and recovery. Further validation could support the use of FDCR-derived measures, potentially accelerating treatment development and improving diagnostic, prognostic, and predictive clinical judgments.

Successful expansion of hospital-associated clone of vanA-positive vancomycin-resistant Enterococcus faecalis ST9 to an anthropogenically polluted mangrove in Brazil.

Mangrove ecosystems are hotspots of biodiversity, but have been threatened by anthropogenic activities. Vancomycin-resistant enterococci (VRE) are nosocomial bacteria classified as high priority by the World Health Organization (WHO). Herein, we describe the identification and genomic characteristics of a vancomycin-resistant Enterococcus faecalis strain isolated from a highly impacted mangrove ecosystem of the northeastern Brazilian, in 2021. Genomic analysis confirmed the existence of the transposon Tn1546-vanA and clinically relevant antimicrobial resistance genes, such as streptogramins, tetracycline, phenicols, and fluoroquinolones. Virulome analysis identified several genes associated to adherence, immune modulation, biofilm, and exoenzymes production. The UFSEfl strain was assigned to sequence type (ST9), whereas phylogenomic analysis with publicly available genomes from a worldwide confirmed clonal relatedness with a hospital-associated Brazilian clone. Our findings highlight the successful expansion of hospital-associated VRE in a mangrove area and shed light on the need for strengthening genomic surveillance of WHO priority pathogens in these vital ecosystems.

Efficacy of a Longitudinal Project-Based Quality Improvement Curriculum in Pediatric Cardiology Fellowship.

Quality improvement knowledge is a requirement of fellowship training. Our goal was to evaluate the efficacy of a 3-year quality improvement and patient safety (QI/PS) curriculum that gives fellows both didactic knowledge and first-hand experience with improvement science, and meets Clinical Learning Environment Review (CLER) requirements. Knowledge assessment is obtained through pre- and post-surveys. A secondary measure of success is academic products resulting from fellows' QI/PS work, and future participation in QI/PS efforts. Since 2019, 51 pre-tests and 36 post-tests were completed, showing improvement across all competencies. Fellows have produced one published manuscript, two poster presentations, and two oral presentations describing their improvement work. Additionally, mentoring faculty members have gone on to lead other QI work throughout the division. This longitudinal QI/PS curriculum provides both knowledge and experience in QI/PS work. It also creates opportunities for academic publications and presentations, builds faculty expertise, and most importantly, works to improve multiple aspects of patient care. This curriculum can serve as a model for other cardiology fellowships working to meet CLER requirements.

App-Delivered Mindfulness Training to Reduce Anxiety in People with HIV Who Smoke: A One-Armed Feasibility Trial.

INTRODUCTION: People with HIV (PWH) who smoke have reported that managing anxiety is a barrier to making a quit attempt and maintaining abstinence post-quit. This study examined the feasibility and acceptability of an app-based mindfulness intervention, Unwinding Anxiety, to reduce anxiety prior to a quit attempt in PWH who were not planning to quit in the next 30 days. METHODS: Sixteen PWH (mean age 51.5 [SD = 13.2]; mean cigarettes per day 11.4 [SD = 5.4]) were enrolled and followed for eight weeks. A smartphone-based app with 30 modules designed to reduce anxiety was introduced at baseline; participants were encouraged to complete one module daily for four weeks. Symptoms of anxiety and readiness to quit smoking were measured at baseline and weeks 4 and 8. The mean number of modules completed, session attendance, and number of study completers were examined. Generalized estimating equations (GEE) were used to examine changes in self-reported anxiety and readiness to quit at baseline, week 4, and week 8. A brief qualitative interview was conducted at week 4 to explore the acceptability of the app. RESULTS: Feasibility was high, with 93% of participants completing the study. The mean number of study sessions completed was 2.7 (SD = 0.59), and the mean number of modules completed was 16.0 (SD 16.8). Anxiety was high at baseline (M = 14.4, SD = 3.9), but lower at week 4 (b = -5.5; CI: [-9.4, -1.7]; p = 0.004) and week 8 (b = -5.1; CI: [-8.8, -1.3]; p = 0.008), and stable between weeks 4 and 8 (b = 0.48; CI: [-2.0, 3.0]; p = 0.706). Readiness to quit significantly increased from baseline M = 5.5 (SD = 1.6) to week 4 (b = 0.56; CI: [0.20, 0.91]; p = 0.002) but was not significantly different from baseline at week 8 (b = 0.34; CI: [-0.30, 1.0]; p = 0.30). Ad-hoc moderation analyses found that anxiety had a small significantly positive association with readiness to quit at baseline (main effect: b = 0.10; SE = 0.03; p < 0.001) and significantly attenuated the increase in readiness to quit observed at week 4 (anxiety by week 4 interaction: b = -0.08; SE = 0.03; p = 0.009). CONCLUSIONS: App-based mindfulness training appears to be feasible and acceptable for PWH who smoke and report baseline anxiety. At week 4, anxiety was reduced and readiness to quit was increased, perhaps a key time point for a smoking cessation attempt.

Cluster-based psychological phenotyping and differences in anxiety treatment outcomes.

The identification of markers of mental health illness treatment response and susceptibility using personalized medicine has been elusive. In the context of psychological treatment for anxiety, we conducted two studies to identify psychological phenotypes with distinct characteristics related to: psychological intervention modalities (mindfulness training/awareness), mechanism of action (worry), and clinical outcome (generalized anxiety disorder scale scores). We also examined whether phenotype membership interacted with treatment response (Study 1) and mental health illness diagnosis (Studies 1-2). Interoceptive awareness, emotional reactivity, worry, and anxiety were assessed at baseline in treatment-seeking individuals (Study 1, n = 63) and from the general population (Study 2, n = 14,010). In Study 1, participants were randomly assigned to an app-delivered mindfulness program for anxiety for two months or treatment as usual. Changes in anxiety were assessed 1 and 2 months post-treatment initiation. In studies 1-2, three phenotypes were identified: 'severely anxious with body/emotional awareness' (cluster 1), 'body/emotionally unaware' (cluster 2), and 'non-reactive and aware' (cluster 3). Study 1's results revealed a significant treatment response relative to controls (ps < 0.001) for clusters 1 and 3, but not for cluster 2. Chi-square analyses revealed that phenotypes exhibited significantly different proportions of participants with mental health diagnoses (studies 1-2). These results suggest that psychological phenotyping can bring the application of personalized medicine into clinical settings.Registry name and URL: Developing a novel digital therapeutic for the treatment of generalized anxiety disorder https://clinicaltrials.gov/ct2/show/NCT03683472?term=judson+brewer&draw=1&rank=1 .Trial registration: Registered at clinicaltrials.gov (NCT03683472) on 25/09/2018.

Remote Care Adoption in Underserved Congenital Heart Disease Patients During the COVID-19 Era.

The COVID-19 pandemic restricted in-person appointments and prompted an increase in remote healthcare delivery. Our goal was to assess access to remote care for complex pediatric cardiology patients. We performed a retrospective chart review of Texas Children's Hospital (TCH) pediatric cardiology outpatient appointments from March 2020 to December 2020 for established congenital heart disease (CHD) patients 1 to 17 yo. Primary outcome variables were remote care use of telemedicine and patient portal activation. Primary predictor variables were age, sex, insurance, race/ethnicity, language, and location. Descriptive statistics were used to analyze patient demographics. Multivariate logistic regression determined associations with remote care use (p < 0.05). We identified 5,410 established patients with clinic appointments during the identified timeframe. Adopters of telemedicine included 13% of patients (n = 691). Of the prior non patient portal users, 4.5% activated their accounts. On multivariate analysis, older age (10-17 yo) was associated with increased telemedicine (OR 2.04, 95%CI 1.71, 2.43) and patient portal use (OR 1.70, 95%CI 1.33, 2.17). Public insurance (OR 1.66, 95%CI 1.25, 2.20) and Spanish speaking were associated with increased patient portal adoption. Race/ethnicity was not significantly associated with telemedicine use or patient portal adoption. Telehealth adoption among older children may be indicative of their ability to aid in the use of these technologies. Higher participation in patient portal activation among publicly insured and Spanish speaking patients is encouraging and demonstrates ability to navigate some degree of remote patient care. Adoption of remote patient care may assist in reducing access to care disparities.

Clinical Predictors of Recurrent Supraventricular Tachycardia in Infancy.

BACKGROUND: Data regarding recurrence risk among infants with supraventricular tachycardia (SVT) are limited. OBJECTIVES: The purpose of this study was to determine incidence and factors associated with SVT recurrence. METHODS: This was a retrospective single-center study (1984-2020) with prospective phone follow-up of infants with structurally normal hearts diagnosed at age ≤1 year with re-entrant SVT. Primary outcome was first SVT recurrence after hospital discharge. Classification and regression tree analysis was performed to determine a risk algorithm. RESULTS: Among 460 infants (62% male), 87% were diagnosed at ≤60 days of age (median 13 days; IQR: 1-31 days). During a median follow-up of 5.2 years (IQR: 1.8-11.2 years), 33% had recurrence. On multivariable analysis, factors associated with recurrence included: fetal or late (>60 days) diagnosis (HR: 1.90; 95% CI: 1.26-2.86; and HR: 1.73; 95% CI: 1.07-2.77, respectively), Wolff-Parkinson-White (WPW) syndrome (HR: 2.46; 95% CI: 1.75-3.45), and need for multi-antiarrhythmic or second-line therapy (HR: 2.08; 95% CI: 1.45-2.99). Based on the classification and regression tree analysis, WPW incurred the highest risk. Among those without WPW, age at diagnosis was the most important factor predicting risk. Fetal or late diagnosis incurred higher risk, and if multi-antiarrhythmic or second-line therapy was also required, risk nearly doubled. Infants without WPW, who were diagnosed early (0-60 days), and who were discharged on propranolol were at lowest recurrence risk. CONCLUSIONS: Infants with SVT are most likely to be diagnosed at ≤60 days and be male. Risk factors for recurrence (occurred in 33%), present at time of diagnosis, include WPW, fetal or late diagnosis, and multi-antiarrhythmic or second-line therapy. Infants with early diagnosis, without WPW, and discharged on first-line monotherapy are at lowest recurrence risk.

Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy for Depression: A Systematic Review of Cognitive Outcomes.

Objectives: Summarize existing literature on cognitive outcomes of MBSR and MBCT for individuals with depression. Methods: Following PRISMA (2021) guidance, we conducted a systematic review. We searched databases for studies published from 2000 to 2020 which examined cognitive outcomes of MBSR and MBCT in individuals with at least mild depressive symptoms. The search result in 10 studies (11 articles) meeting inclusion criteria. Results: We identified five single armed trials and five randomized controlled trials. Results indicated that three studies did not show any improvements on cognitive outcomes, and seven studies showed at least one improvement in cognitive outcomes. Conclusions: Overall, the review highlighted several inconsistencies in the literature including inconsistent use of terminology, disparate samples, and inconsistent use of methodology. These inconsistencies may help to explain the mixed results of MBSR and MBCT on cognitive outcomes. Recommendations include a more streamlined approach to studying cognitive outcomes in depressed individuals in the context of MBSR and MBCT.

App-Based Mindfulness Training Predicts Reductions in Smoking Behavior by Engaging Reinforcement Learning Mechanisms: A Preliminary Naturalistic Single-Arm Study.

Mindfulness training (MT) has been shown to influence smoking behavior, yet the involvement of reinforcement learning processes as underlying mechanisms remains unclear. This naturalistic, single-arm study aimed to examine slope trajectories of smoking behavior across uses of our app-based MT craving tool for smoking cessation, and whether this relationship would be mediated by the attenuating impact of MT on expected reward values of smoking. Our craving tool embedded in our MT app-based smoking cessation program was used by 108 participants upon the experience of cigarette cravings in real-world contexts. Each use of the tool involved mindful awareness to the experience of cigarette craving, a decision as to whether the participant wanted to smoke or ride out their craving with a mindfulness exercise, and paying mindful attention to the choice behavior and its outcome (contentment levels felt from engaging in the behavior). Expected reward values were computed using contentment levels experienced from the choice behavior as the reward signal in a Rescorla−Wagner reinforcement learning model. Multi-level mediation analysis revealed a significant decreasing trajectory of smoking frequency across MT craving tool uses and that this relationship was mediated by the negative relationship between MT and expected reward values (all ps < 0.001). After controlling for the mediator, the predictive relationship between MT and smoking was no longer significant (p < 0.001 before and p = 0.357 after controlling for the mediator). Results indicate that the use of our app-based MT craving tool is associated with negative slope trajectories of smoking behavior across uses, mediated by reward learning mechanisms. This single-arm naturalistic study provides preliminary support for further RCT studies examining the involvement of reward learning mechanisms underlying app-based mindfulness training for smoking cessation.

Targeting Anxiety to Improve Sleep Disturbance: A Randomized Clinical Trial of App-Based Mindfulness Training.

OBJECTIVE: Sleep disturbance is experienced by nearly 20% of Americans and is highly comorbid with anxiety. Sleep disturbances may predict the development of anxiety disorders. Mindfulness training (MT) has shown efficacy for anxiety yet remains limited by in-person-based delivery. Digitally delivered MT may target habitual worry processes, yet its effects on sleep have not been studied. This study tested if app-based MT for anxiety could reduce worry and improve sleep and examined the underlying mechanisms. METHODS: Individuals reporting worry interfering with sleep were randomized to treatment as usual (TAU; n = 40) or TAU + app-based MT (n = 40). Treatment-related changes in worry-related sleep disturbances (WRSDs), worry, nonreactivity, and anxiety were evaluated via self-report questionnaires at 1 and 2 months after treatment initiation. Fitbit devices were used to record total sleep time and estimate sleep efficiency. At 2 months, TAU received access to app-based MT, and both groups were reassessed at 4 months. RESULTS: In a modified intent-to-treat analysis, WRSD scores decreased by 27% in TAU + MT (n = 36) and 6% in TAU (n = 35) at 2 months (median [IQR] change = 11 [4.3] versus 15 [5.0], p = .001). These WRSD reductions were mediated by decreased worry, particularly improved nonreactivity (p values < .001). At 4 months, TAU reported a significant 29% reduction after beginning app-based MT at 2 months and TAU + MT maintained its gains. No significant between-group differences in average estimated total sleep time or sleep efficiency were found after 2 months of using the app. CONCLUSIONS: Few mindfulness-related apps have been evaluated for clinical efficacy and/or mechanism. Results from this study demonstrate a mechanistic link between MT and increased emotional nonreactivity, decreased worry, and reduction in reported sleep disturbances, suggesting that app-based MT may be a viable option to help individuals who report that worry interferes with their sleep.Trial Registration: ClinicalTrials.gov identifier: NCT03684057.

Mindfulness-Based Programs: Why, When, and How to Adapt?

This paper provides a framework for understanding why, when and how to adapt mindfulness-based programs (MBPs) to specific populations and contexts, based on research that developed and adapted multiple MBPs. In doing so, we hope to support teachers, researchers and innovators who are considering adapting an MBP to ensure that changes made are necessary, acceptable, effective, cost-effective, and implementable. Specific questions for reflection are provided such as (1) Why is an adaptation needed? (2) Does the theoretical premise underpinning mainstream MBPs extend to the population you are considering? (3) Do the benefits of the proposed adaptation outweigh the time and costs involved to all in research and implementation? (4) Is there already an evidenced-based approach to address this issue in the population or context? Fundamental knowledge that is important for the adaptation team to have includes the following: (1) essential ingredients of MBPs, (2) etiology of the target health outcome, (3) existing interventions that work for the health outcome, population, and context, (4) delivery systems and settings, and (5) culture, values, and communication patterns of the target population. A series of steps to follow for adaptations is provided, as are case examples. Adapting MBPs happens not only by researchers, but also by MBP teachers and developers, who endeavor to best serve the populations and contexts they work within. We hope that these recommendations for best practice provide a practical framework for skilfully understanding why, when, and how to adapt MBPs; and that this careful approach to adaptation maximizes MBP safety and efficacy.

Hope is No Plan: Uncovering Actively Missing Transition-Aged Youth with Congenital Heart Disease.

Studies describing gaps in care for youth with congenital heart disease (CHD), focus on those who have returned to care, but rarely those actively missing from care. Our objective was to determine barriers for young adults with CHD actively missing from cardiac care and to re-engage them in care. Retrospective single-center cohort study of cardiology clinic patients ages 15-21 years with CHD between 2012 and 2019 for patients actively missing from care (≥ 12 months beyond requested clinic follow-up). We conducted prospective interviews, offered clinic scheduling information, and recorded cardiac follow-up. Data analyzed using descriptive statistics, univariable, and multivariable logistic regression. Of 1053 CHD patients, 33% (n = 349) were actively missing. Of those missing, 58% were male and median age was 17 years (IQR 16-19). Forty-six percent were Non-Hispanic White, 33% Hispanic, and 9% Black. Moderately complex CHD was in 71%, and 62% had private insurance. Patients with simple CHD, older age at last encounter (18-21), and scheduled follow-up > 12 months from last encounter were more likely to be actively missing. Interviews were completed by 125 patients/parents (36%). Lack of cardiac care was reported in 52%, and common barriers included: insurance (33%), appointment scheduling (26%), and unknown ACHD center care (15%). Roughly half (55%) accepted appointment information, yet only 3% successfully returned. Many patients require assistance beyond CHD knowledge to maintain and re-engage in care. Future interventions should include scheduling assistance, focused insurance maintenance, understanding where to obtain ACHD care, and educating on need for lifelong care.

Mindfulness-based interventions among people of color: A systematic review and meta-analysis.

Objective In the United States, people of color (POC) are disproportionately affected by various sources of stress and prevalent mental and physical health issues that may benefit from Mindfulness-based Interventions (MBIs). However, effects of MBIs for POC are unclear. This meta-analysis examines the efficacy of MBIs through randomized controlled trials (RCTs) that included predominately POC (≥75% of the sample). Method: Random effects models were used to synthesize effect sizes. A total of 24 RCT samples were analyzed. Results: Samples were on average 94.4% POC and predominantly from low-income backgrounds (total N = 2,156). At post-treatment, MBIs yielded small but statistically superior outcomes to active controls (Hedges' g = 0.11) and inactive controls (g = 0.26). Compared to active controls, MBIs' effects on well-being were smaller than their effects on other outcome types. Compared to inactive controls, MBIs that focused on non-clinical populations and had higher proportion of POC had larger effect sizes. Attrition rates of MBIs did not differ from other active conditions in outpatient settings. Conclusion: Findings provide modest, preliminary empirical support for MBIs among POC. We discuss main findings, limitations, and implications for future MBI research for health promotion among POC.

Comprehensive Improvement of Cardiology Inpatient Transfers: A Bed-availability Triggered Approach.

Introduction: Patient transfers pose a potential risk during hospitalizations. Structured communication practices are necessary to ensure effective handoffs, but occur amidst competing priorities and constraints. We sought to design and implement a multidisciplinary process to enhance communication between pediatric cardiovascular intensive care unit and cardiology floor teams with a comprehensive approach evaluating efficiency, safety, and culture. Methods: We conducted a prospective quality improvement study to enact a bed-availability triggered bedside handoff process. The primary aim was to reduce the time between handoff and unit transfer. Secondary metrics captured the impact on safety (reported safety events, overnight transfers, bounce backs, and I-PASS utilization), efficiency (transfer latency, unnecessary patient handoffs, and cumulative time providers were engaged in handoffs), and culture (team members perceptions of satisfaction, collaboration, and handoff efficiency via survey data). Results: Eighty-two preimplementation surveys, 26 stakeholder interviews, and 95 transfers were completed during the preintervention period. During the postintervention period, 145 handoffs were audited. We observed significant reductions in transfer latency, unnecessary handoffs, and cumulative provider handoff time. Overnight transfers decreased, and no negative impact was observed in reported safety events or bouncebacks. Survey results showed a positive impact on collaboration, efficiency, and satisfaction among team members. Conclusions: Developing safer handoff practices require a collaborative, structured, and stepwise approach. Advances are attainable in high-volume centers, and comprehensive measurement of change is necessary to ensure a positive impact on the overall patient and provider environment.

Clinical Efficacy and Psychological Mechanisms of an App-Based Digital Therapeutic for Generalized Anxiety Disorder: Randomized Controlled Trial.

BACKGROUND: Current treatments for generalized anxiety disorder (GAD) often yield suboptimal outcomes, partly because of insufficient targeting of underlying psychological mechanisms (eg, avoidance reinforcement learning). Mindfulness training (MT) has shown efficacy for anxiety; yet, widespread adoption has been limited, partly because of the difficulty in scaling in-person-based delivery. Digital therapeutics are emerging as potentially viable treatments; however, very few have been empirically validated. OBJECTIVE: The aim of this study is to test the efficacy and mechanism of an app-delivered MT that was designed to target a potential mechanism of anxiety (reinforcement learning), based on which previous studies have shown concern regarding feedback and the perpetuation of anxiety through negative reinforcement. METHODS: Individuals with GAD were recruited using social media advertisements and randomized during an in-person visit to receive treatment as usual (n=33) or treatment as usual+app-delivered MT (Unwinding Anxiety; n=32). The latter was composed of 30 modules to be completed over a 2-month period. Associated changes in outcomes were assessed using self-report questionnaires 1 and 2 months after treatment initiation. RESULTS: We randomized 65 participants in this study, and a modified intent-to-treat approach was used for analysis. The median number of modules completed by the MT group was 25.5 (IQR 17) out of 30; 46% (13/28) of the participants completed the program. In addition, the MT group demonstrated a significant reduction in anxiety (GAD-7) compared with the control group at 2 months (67% vs 14%; median change in GAD-7: -8.5 [IQR 6.5] vs -1.0 [IQR 5.0]; P<.001; 95% CI 6-10). Increases in mindfulness at 1 month (nonreactivity subscale) mediated decreases in worry at 2 months (Penn State Worry Questionnaire; P=.02) and decreases in worry at 1 month mediated reductions in anxiety at 2 months (P=.03). CONCLUSIONS: To our knowledge, this is the first report on the efficacy and mechanism of an app-delivered MT for GAD. These findings demonstrate the clinical efficacy of MT as a digital therapeutic for individuals with anxiety (number needed to treat=1.6). These results also link recent advances in our mechanistic understanding of anxiety with treatment development, showing that app-delivered MT targets key reinforcement learning pathways, resulting in tangible, clinically meaningful reductions in worry and anxiety. Evidence-based, mechanistically targeted digital therapeutics have the potential to improve health at a population level at a low cost. TRIAL REGISTRATION: ClinicalTrials.gov NCT03683472; https://clinicaltrials.gov/ct2/show/NCT03683472.

Smartband-Based Automatic Smoking Detection and Real-time Mindfulness Intervention: Protocol for a Feasibility Trial.

BACKGROUND: Smoking is the leading cause of preventable death in the United States. Smoking cessation interventions delivered by smartphone apps are a promising tool for helping smokers quit. However, currently available smartphone apps for smoking cessation have not exploited their unique potential advantages to aid quitting. Notably, few to no available apps use wearable technologies, most apps require users to self-report their smoking, and few to no apps deliver treatment automatically contingent upon smoking. OBJECTIVE: This pilot trial tests the feasibility of using a smartband and smartphone to monitor and detect smoking and deliver brief mindfulness interventions in real time to reduce smoking. METHODS: Daily smokers (N=100, ≥5 cigarettes per day) wear a smartband for 60 days to monitor and detect smoking, notify them about their smoking events in real time, and deliver real-time brief mindfulness exercises triggered by detected smoking events or targeted at predicted smoking events. Smokers set a quit date at 30 days. A three-step intervention to reduce smoking is tested. First, participants wear a smartband to monitor and detect smoking, and notify them of smoking events in real time to bring awareness to smoking and triggers for 21 days. Next, a "mindful smoking" exercise is triggered by detected smoking events to bring a clear recognition of the actual effects of smoking for 7 days. Finally, after their quit date, a "RAIN" (recognize, allow, investigate, nonidentification) exercise is delivered to predicted smoking events (based on the initial 3 weeks of tracking smoking data) to help smokers learn to work mindfully with cravings rather than smoke for 30 days. The primary outcomes are feasibility measures of treatment fidelity, adherence, and acceptability. The secondary outcomes are smoking rates at end of treatment. RESULTS: Recruitment for this trial started in May 2021 and will continue until November 2021 or until enrollment is completed. Data monitoring and management are ongoing for enrolled participants. The final 60-day end of treatment data is anticipated in January 2022. We expect that all trial results will be available in April 2022. CONCLUSIONS: Findings will provide data and information on the feasibility of using a smartband and smartphone to monitor and detect smoking and deliver real-time brief mindfulness interventions, and whether the intervention warrants additional testing for smoking cessation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03995225; https://clinicaltrials.gov/ct2/show/NCT03995225. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32521.

Can Approaching Anxiety Like a Habit Lead to Novel Treatments?

Anxiety disorders make up the most prevalent class of mental illnesses. Given the growing prevalence of anxiety in the United States and beyond, there is an urgent clinical need to develop nonpharmacologic treatments that effectively treat and reduce its core symptoms (eg, worry). A leading theory posits that although worrying may be unpleasant, the immediate emotions that are avoided by concentrating on worry are often perceived as more aversive (eg, fear, anger, grief). From a mechanistic perspective, worry is thought to be learned and reinforced in a similar manner to other types of positively and negatively reinforced behaviors: habits. Mindfulness training, a practice that brings awareness to cognitive, affective, and physiological experiences, when delivered in-person via programs such as mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT), has demonstrated effectiveness in reducing anxiety, but is difficult to scale in this manner. In this review, we explore novel approaches to using mindfulness training to specifically target the theoretical mechanisms underlying the perpetuation of anxiety (eg, worry as a habit), and the emergence of mobile health platforms (eg, digital therapeutics) as potential vehicles for remote delivery of treatment.