Developing the Workforce of the Digital Future: mHealth Competency and Fidelity Measurement in Community-Based Care.

Integrating mobile health (mHealth) interventions into settings that serve diverse patient populations requires that prerequisite professional competencies are delineated and that standards for clinical quality assurance can be pragmatically assessed. Heretofore, proposed mHealth competencies have been broad and have lacked a framework to support specific applications. We outline the meta-competencies identified in the literature relevant to mHealth interventions and demonstrate how these meta-competencies can be integrated with population- and intervention-related competencies to help guide a pragmatic approach to competency assessment. We present a use case based on FOCUS-an evidence-based mHealth intervention designed for individuals with serious mental illness and currently being implemented in geographically and demographically diverse community behavioral health settings. Subsequent to identifying the cross-cutting competencies relevant to the target population (outpatients experiencing psychotic symptoms), substratal intervention (Cognitive Behavioral Therapy for psychosis), and treatment modality (mHealth), we detail the development process of an mHealth fidelity monitoring system (mHealth-FMS). We adhered to a published sequential 5-step process to design a fidelity monitoring system that aligns with our integrated mHealth competency framework and that was guided by best practices prescribed by the Treatment Fidelity Workgroup of the National Institutes of Health Behavior Change Consortium. The mHealth-FMS is intended to enhance both clinical and implementation outcomes by grounding the mHealth interventionist and the system of care in which they operate in the core functions, tasks, knowledge, and competencies associated with system-integrated mHealth delivery. Future research will explore acceptability and feasibility of the mHealth-FMS.

Quantifying abnormal emotion processing: A novel computational assessment method and application in schizophrenia.

Abnormal emotion processing is a core feature of schizophrenia spectrum disorders (SSDs) that encompasses multiple operations. While deficits in some areas have been well-characterized, we understand less about abnormalities in the emotion processing that happens through language, which is highly relevant for social life. Here, we introduce a novel method using deep learning to estimate emotion processing rapidly from spoken language, testing this approach in male-identified patients with SSDs (n = 37) and healthy controls (n = 51). Using free responses to evocative stimuli, we derived a measure of appropriateness, or "emotional alignment" (EA). We examined psychometric characteristics of EA and its sensitivity to a single-dose challenge of oxytocin, a neuropeptide shown to enhance the salience of socioemotional information in SSDs. Patients showed impaired EA relative to controls, and impairment correlated with poorer social cognitive skill and more severe motivation and pleasure deficits. Adding EA to a logistic regression model with language-based measures of formal thought disorder (FTD) improved classification of patients versus controls. Lastly, oxytocin administration improved EA but not FTD among patients. While additional validation work is needed, these initial results suggest that an automated assay using spoken language may be a promising approach to assess emotion processing in SSDs.

Phosphorylation of cardiac sodium channel at Ser571 anticipates manifestations of the aging myopathy.

Diastolic dysfunction and delayed ventricular repolarization are typically observed in the elderly, but whether these defects are intimately associated with the progressive manifestation of the aging myopathy remains to be determined. In this regard, aging in experimental animals is coupled with increased late Na+ current (INa,L) in cardiomyocytes, raising the possibility that INa,L conditions the modality of electrical recovery and myocardial relaxation of the aged heart. For this purpose, aging male and female wild-type (WT) C57Bl/6 mice were studied together with genetically engineered mice with phosphomimetic (gain of function, GoF) or ablated (loss of function, LoF) mutations of the sodium channel Nav1.5 at Ser571 associated with, respectively, increased and stabilized INa,L. At ∼18 mo of age, WT mice developed prolonged duration of the QT interval of the electrocardiogram and impaired diastolic left ventricular (LV) filling, defects that were reversed by INa,L inhibition. Prolonged repolarization and impaired LV filling occurred prematurely in adult (∼5 mo) GoF mutant mice, whereas these alterations were largely attenuated in aging LoF mutant animals. Ca2+ transient decay and kinetics of myocyte shortening/relengthening were delayed in aged (∼24 mo) WT myocytes, with respect to adult cells. In contrast, delayed Ca2+ transients and contractile dynamics occurred at adult stage in GoF myocytes and further deteriorated in old age. Conversely, myocyte mechanics were minimally affected in aging LoF cells. Collectively, these results document that Nav1.5 phosphorylation at Ser571 and the late Na+ current modulate the modality of myocyte relaxation, constituting the mechanism linking delayed ventricular repolarization and diastolic dysfunction.NEW & NOTEWORTHY We have investigated the impact of the late Na current (INa,L) on cardiac and myocyte function with aging by using genetically engineered animals with enhanced or stabilized INa,L, due to phosphomimetic or phosphoablated mutations of Nav1.5. Our findings support the notion that phosphorylation of Nav1.5 at Ser571 prolongs myocardial repolarization and impairs diastolic function, contributing to the manifestations of the aging myopathy.

Restoring Trust for People With Psychosis Through Psychotherapy.

ABSTRACT: Mistrust is a significant problem for people with psychosis and can interfere with their capacity to engage in psychosocial treatment. In this article, the developmental trajectory of mistrust is outlined, including the impact that attachment disruption, childhood trauma, attributional biases, internalized stigma, and discrimination can have on the person's capacity to form trusting bonds with others. After this review, three elements are described that may allow for the restoration of trust: the therapist's openness to understanding the patient's experience and agenda for therapy, the therapist's effort to honestly disclose their thoughts to encourage dialogue and mutual reflection, and therapist's attempt to promote metacognition through helping the patient develop more complex representations of the minds of others. These elements are framed in the context of metacognitive reflection and insight therapy, an integrative therapy that is well suited to address mistrust through its explicit focus on metacognition and intersubjectivity.

Identifying mechanisms of persecutory ideation maintenance with smartphone technology: Examining threat importance, certainty, rumination, and behavior change.

Previous cross-sectional and laboratory research has identified risk factors for persecutory ideation including rumination, negative affect, and safety-seeking behaviors. Questions remain about what in-the-moment factors link general negative affect to PI as well as which maintain PI over time. In the present study, N = 219 individuals completed momentary assessments of PI as well as four factors (attributing threats as certain and important, ruminating, and changing one's behavior in response) proposed to maintain PI over time. Linear mixed effects models were used to analyze multiple time-varying relationships, including these factors predicting negative affect and vice versa, as well as factors predicting maintenance of PI over time. Linear mixed effects models were used to analyze multiple time-varying relationships, examining each PI-related factor predicting negative affect, negative affect predicting each PI-related factor, as well as each factor predicting maintenance of PI over time. All four factors were associated with increases in subsequent day self-reported severity of PI, suggesting all four increased the likelihood of maintaining or worsening next-day PI. Results of this study confirm that the proposed factors are key in maintaining a cycle by which PI and negative affect are maintained over time. These factors may represent targets for momentary interventions.

Cost of Implementing mHealth in Community Mental Health Settings: External Versus Internal Facilitation.

OBJECTIVE: This study aimed to compare the costs of two implementation models for the mobile health (mHealth) intervention FOCUS in community mental health settings. The external facilitation (EF) approach uses a hub-and-spoke model, in which a central specialist provides support to clinicians and clients at multiple agencies. With the internal facilitation (IF) approach, frontline clinical staff at each center are trained to serve as their organization's local specialists. METHODS: Financial and economic cost data were collected in the context of a hybrid type 3 effectiveness-implementation trial by using a mixed-methods, top-down expenditure analysis with microcosting approaches. The analysis compared the incremental costs of both models and the costs of successfully engaging clients (N=210) at 20 centers. Costs were characterized as start-up or recurrent (personnel, supplies, contracted services, and indirect costs). RESULTS: The average annual financial cost per site was $23,517 for EF and $19,118 for IF. EF yielded more FOCUS users at each center, such that the average monthly financial costs were lower for EF ($167 per client [N=129]) than for IF ($177 per client [N=81]). When using a real-world scenario based on economic costs and a lower organizational indirect rate, the average monthly cost per client was $73 for EF and $59 for IF. Both models reflected substantial cost reductions (about 50%) relative to a previous deployment of FOCUS in a clinical trial. CONCLUSIONS: Compared with IF, EF yielded more clients who received mHealth at community mental health centers and had comparable or lower costs.

User-Centered Development of Bolster, an mHealth Intervention for Early Psychosis Caregivers: Needs Assessment, Prototyping, and Field Trial.

BACKGROUND: Caregivers play a critical role in the treatment and recovery of youth and young adults at risk for psychosis. Caregivers often report feeling isolated, overwhelmed, and lacking in resources. Mobile health (mHealth) has the potential to provide scalable, accessible, and in-the-moment support to caregivers. To date, few if any mHealth resources have been developed specifically for this population. OBJECTIVE: The aim of this study was to conduct user-centered design and testing of an mHealth intervention to support early psychosis caregivers. METHODS: We conducted a multiphase user-centered development process to develop the Bolster mobile app. In phase 1, a total of 21 caregivers were recruited to participate in a qualitative needs assessment and respond to an initial prototype of the Bolster platform. Content analysis was used to identify key needs and design objectives, which guided the development of the Bolster mobile app. In phase 2, a total of 11 caregivers were recruited to participate in a 1-week field trial wherein they provided qualitative and quantitative feedback regarding the usability and acceptability of Bolster; in addition, they provided baseline and posttest assessments of the measures of distress, illness appraisals, and family communication. RESULTS: In phase 1, participants identified psychoeducation, communication coaching, a guide to seeking services, and support for coping as areas to address. Live prototype interaction sessions led to multiple design objectives, including ensuring that messages from the platform were actionable and tailored to the caregiver experience, delivering messages in multiple modalities (eg, video and text), and eliminating a messaging-style interface. These conclusions were used to develop the final version of Bolster tested in the field trial. In phase 2, of the 11 caregivers, 10 (91%) reported that they would use Bolster if they had access to it and would recommend it to another caregiver. They also reported marked changes in their appraisals of illness (Cohen d=0.55-0.68), distress (Cohen d=1.77), and expressed emotion (Cohen d=0.52). CONCLUSIONS: To our knowledge, this study is the first to design an mHealth intervention specifically for early psychosis caregivers. Preliminary data suggest that Bolster is usable, acceptable, and promising to improve key targets and outcomes. A future fully powered clinical trial will help determine whether mHealth can reduce caregiver burdens and increase engagement in services among individuals affected by psychosis.

Using Smartphones to Identify Momentary Characteristics of Persecutory Ideation Associated With Functional Disability.

Objectives: Though often a feature of schizophrenia-spectrum disorders, persecutory ideation (PI) is also common in other psychiatric disorders as well as among individuals who are otherwise healthy. Emerging technologies allow for a more thorough understanding of the momentary phenomenological characteristics that determine whether PI leads to significant distress and dysfunction. This study aims to identify the momentary phenomenological features of PI associated with distress, dysfunction, and need for clinical care. Methods: A total of 231 individuals with at least moderate PI from 43 US states participated in a study involving 30 days of data collection using a smartphone data collection system combining ecological momentary assessment and passive sensors, wherein they reported on occurrence of PI as well as related appraisals, responses, and cooccurring states. Most (N = 120, 51.9%) participants reported never having received treatment for their PI, while 50 participants had received inpatient treatment (21.6%), and 60 (26.4%) had received outpatient care only. Results: Individuals with greater functional disability did not differ in PI frequency but were more likely at the moment to describe threats as important to them, to ruminate about those threats, to experience distress related to them, and to change their behavior in response. Groups based on treatment-seeking patterns largely did not differ in baseline measures or momentary phenomenology of PI as assessed by self-report or passive sensors. Conclusions: Smartphone data collection allows for granular assessment of PI-related phenomena. Functional disability is associated with differences in appraisals of and responses to PI at the moment.

Alcohol septal ablation in patients aged 75 years or older with hypertrophic obstructive cardiomyopathy.

OBJECTIVE: Outcome data for patients ≥75 years with hypertrophic obstructive cardiomyopathy (HOCM) undergoing alcohol septal ablation (ASA) are lacking. Therefore, a retrospective single-centre analysis was conducted. METHODS: The data of all consecutive ASAs, that were performed at our institution between 1 September 1997 and 31 July 2021 in patients with HOCM with left ventricular outflow tract gradients (LVOTG) ≥50 mm Hg, were collected from patient reports. ASA was performed per institutional standards with 95% ethanol infused into a feasible septal branch. Differences regarding echocardiographic, procedural and clinical parameters at baseline and after 6 months between patients ≥75 years and <75 years were assessed. RESULTS: We found 208 ASAs in patients ≥75 years (85.1% female; age 78.0 years (IQR 76.0-80.0)) and 1430 ASAs in patients <75 years (42.0% female; age 56.0 years (IQR 46.0-65.0)). Patients ≥75 years had lower distances in 6 min walk test (baseline: 317.0 m (IQR 242.0-389.0) vs 438.0 m (IQR 353.3-504.0); p<0.0001). Exercise-induced LVOTG calculated at follow-up was lower in patients ≥75 years (29.5 mm Hg (IQR 18.0-54.0) vs 39.5 mm Hg (IQR 23.0-73.8); p=0.0007). There were more high-degree AV blocks after ASA in patients ≥75 years (25.5% vs 13.6%; p<0.0001). The in-hospital mortality did not differ between the groups (age ≥75 years: 1.0%; age <75 years: 0.6%; p=0.6580). CONCLUSION: ASA had similar efficacy and intrahospital mortality in patients ≥75 years compared with younger patients. Higher rates of AV block with need for permanent pacemaker implantation were observed in patients ≥75 years of age.

A preliminary study examining terminology used by individuals with lived experience describing beliefs about being targeted or harmed by others.

While recent studies have prompted re-evaluation of the term "schizophrenia," few have examined the use of terms to describe persecutory ideation (PI) or paranoia. This study examines the preferences and terms used by a cross-diagnostic population of individuals (N = 184) with lived experience using an online survey. Participants most commonly described their PI in terms of the perceived source of threat, followed by clinical language, most commonly variants of "paranoia" and "anxiety." Of five selected terms assessed quantitatively - "anxiety," "paranoia," "persecutory thoughts," "suspiciousness," and "threat thoughts" - participants were more likely to report that "anxiety" aligned with their experience of PI, followed by "suspiciousness." Endorsement of terms more specific to PI was associated with self-report PI severity, while a preference for "anxiety" over other terms was both associated with less severe PI and lower scores on a measure of stigma. These results suggest that the heterogeneity of terms used by individuals with lived experience support a person-centered approach to language describing such experiences.

Cardiovascular Magnetic Resonance Imaging in Patients With Ibrutinib-Associated Cardiotoxicity.

Importance: Ibrutinib has been associated with serious cardiotoxic arrhythmias. In preclinical models, these events are paralleled or proceeded by diffuse myocardial injury (inflammation and fibrosis). Yet whether this is seen in patients or has implications for future cardiotoxic risk is unknown. Objective: To assess the incidence and outcomes of myocardial injury among patients with ibrutinib-related cardiotoxicity. Design, Setting, and Participants: This cohort study included consecutive patients treated with ibrutinib from 2012 to 2019, phenotyped using cardiovascular magnetic resonance (CMR) from a large US Comprehensive Cancer Center registry. Exposures: Ibrutinib treatment for cancer control. Main Outcomes and Measures: The primary outcome was the presence of late gadolinium enhancement (LGE) fibrosis. The secondary outcome was the occurrence of major adverse cardiac events (MACE), defined as atrial fibrillation, heart failure, symptomatic ventricular arrhythmias, and sudden death of probable or definite ibrutinib association after CMR. We also assessed parametric-mapping subclinical fibrosis (native-T1, extracellular volume fraction) and inflammation/edema (max-T2) measures. Cardiovascular magnetic resonance measures were compared with those obtained in similar consecutive patients with cancer without ibrutinib treatment (pretreatment controls). Observed measures were also compared with similar-aged broad population rates (general-population controls) and a broader pool of cardiovascular disease (CVD) risk-matched cancer controls. Multivariable regression was used to assess the association between CMR measures and MACE. Results: Overall, 49 patients treated with ibrutinib were identified, including 33 imaged after treatment initiation (mean [SD] age, 65 [10] years, 9 [27%] with hypertension, and 23 [69.7%] with index-arrhythmias); median duration of ibrutinib-use was 14 months. The mean (SD) pretreatment native T1 was 977.0 (73.0) ms, max-T2 56.5 (4.0) ms, and 4 (13.3%) had LGE. Posttreatment initiation, mean (SD) native T1 was 1033.7 (48.2) ms, max-T2 61.5 (4.8) ms, and 17 (54.8%) had LGE (P < .001, P = .01, and P < .001, respectively, pre- vs post-ibrutinib treatment). Native T12SDs was elevated in 9 (28.6%), and max-T22SDs in 21 (63.0%), respectively. Cardiovascular magnetic resonance measures were highest in those with suspected toxic effects (P = .01 and P = .01, respectively). There was no association between traditional CVD-risk or cancer-treatment status and abnormal CMR measures. Among those without traditional CVD, 16 (58.6%) had LGE vs 38 (13.3%) in matched-controls (relative-risk, 4.8; P < .001). Over a median follow-up of 19 months, 13 (39.4%) experienced MACE. In multivariable models inclusive of traditional CVD risk factors, LGE (hazard ratio [HR], 4.9; P = .04), and native-T12SDs (HR, 3.3; P = .05) associated with higher risks of MACE. Conclusions and Relevance: In this cohort study, myocardial injury was common in ibrutinib users, and its presence was associated with higher cardiotoxic risk.

Hostile attribution bias in schizophrenia-spectrum disorders: narrative review of the literature and persisting questions.

BACKGROUND: Social cognition is often aberrant or impaired in psychotic disorders and related to functional outcomes. In particular, one core social cognitive bias - hostile attribution bias - is proposed to be implicated in paranoia, anxiety, mood disturbances and interpersonal conflict outcomes. However, questions remain about this domain's specificity to psychosis and its relationship to general functional outcomes. AIMS: The present paper offers a descriptive and critical review of the literature on hostile attribution bias in psychotic disorders, in order to examine (1) its impact on persecutory symptoms in schizophrenia-spectrum disorders, (2) impact on other related psychopathology among those experiencing psychosis and (3) relationship to functioning. METHODS: Twenty-eight studies included in this review after parallel literature searches of PsycINFO and PubMed. RESULTS: Evidence from these studies highlighted that hostile attribution bias is elevated in schizophrenia, and that it is related to anxiety, depression and interpersonal conflict outcomes. CONCLUSION: While results suggest that hostile attributions are elevated in schizophrenia and associated with symptoms and functioning, there exist numerous persisting questions in the study of this area, including identifying which measures are most effective and determining how it presents: as a state or trait-like characteristic, via dual processes, and its situational variation.

The relationship between appraisals of auditory verbal hallucinations and real-time affect and social functioning.

In addition to being a hallmark symptom of schizophrenia-spectrum disorders, auditory verbal hallucinations (AVH) are present in a range of psychiatric disorders as well as among individuals who are otherwise healthy. People who experience AVH are heterogeneous, and research has aimed to better understand what characteristics distinguish, among those who experience AVH, those who experience significant disruption and distress from those who do not. The cognitive model of AVH suggests that appraisals of voices determine the extent to which voices cause distress and social dysfunction. Previous work has relied largely on comparisons of "clinical" and "non-clinical" voice hearers, and few studies have been able to provide insight into the moment-to-moment relationships between appraisals and outcomes. The current study examines longitudinal data provided through ecological momentary assessment and passive sensors of 465 individuals who experience cross-diagnostic AVH. Results demonstrated associations of AVH appraisals to negative affect and social functioning. Above and beyond within-individual averages, when a participant reported increased appraisals of their voices as powerful and difficult to control, they were more likely to feel increased negative affect and reduced feelings of safety. AVH power appraisals were also associated with next-day number and duration of phone calls placed, and AVH controllability appraisals were associated with increased time near speech and reduced next-day time away from primary location. These results suggest that appraisals are state-like characteristics linked with day-to-day and moment-to-moment changes in impactful affective and behavioral outcomes; intervention approaches should aim to address these domains in real-time.

Carfilzomib-induced Cardiotoxicity: An Analysis of the FDA Adverse Event Reporting System (FAERS).

Background: Carfilzomib and other proteasome inhibitors (PIs) have revolutionized treatment of multiple myeloma (MM). PIs have proven to be highly effective, but are associated with significant cardiovascular adverse events (AEs). No prior study has compared the cardiotoxicity of carfilzomib against other PI's and all other classes of medications. Objectives: The purpose of this study is to characterize the cardiotoxicity of carfilzomib with respect to other PIs and all classes of medications using the US Food and Drug Administration Adverse Events Reporting System (FAERS) database and to define the observed cardiotoxicity profile. Methods: The FAERS database was queried between years 2017 and 2020 to identify AEs associated with PIs. Data extracted included concomitant medications used, type and severity of AEs and patient characteristics including age, sex, and time from medication initiation to adverse event. Cardiotoxicities assessed included acute myocardial infarction, heart failure, and supraventricular tachycardia. The reporting odds ratio (ROR) and information component assessed the strength of association between PIs and cardiotoxicity. Results: Over the study period, 21,026 adverse events were reported in patients taking carfilzomib among 55,195 total adverse events in patients taking PI's were identified from 6,548,048 total events reported in the FAERS database. The most common AE associated with carfilzomib was development of heart failure (1116 adverse events); disproportionality analysis revealed a stronger association with hypertension and QT prolongation with carfilzomib than other PI's. Conclusions: While they have demonstrated efficacy and revolutionized treatment of MM, carfilzomib and other PI's are associated with cardiotoxicities.

Developing the Workforce of the Digital Future: Leveraging Technology to Train Community-Based Mobile Mental Health Specialists.

Challenges in training, dissemination, and implementation have impeded the ability of providers to integrate promising digital health tools in real-world services. There is a need for generalizable strategies to rapidly train real-world providers at scale to support the adoption of digital health. This study describes the development of principles guiding rapid training of community-based clinicians in the support of digital health. This training approach was developed in the context of an ongoing trial examining implementation strategies for FOCUS, a mobile mental health intervention designed for people with serious mental illness. The SAIL (Simple, Accessible, Inverted, Live) model introduces how digital tools can be leveraged to facilitate rapid training of community agency-based personnel to serve as digital mental health champions, promoters, and providers. This model emphasizes simple and flexible principles of intervention delivery, accessible materials in a virtual learning environment, inverted or "flipped" live training structure, and live consultation calls for ongoing support. These initial insights lay the groundwork for future work to test and replicate generalizable training strategies focused on real-world delivery of digital mental health services. These strategies have the potential to remove key obstacles to the implementation and dissemination of digital health interventions for mental health.

Examining Potential Barriers to mHealth Implementation and Engagement in Schizophrenia: Phone Ownership and Symptom Severity.

Objective: Implementation of mobile health (mhealth) interventions remains limited among those with schizophrenia. This study examined several logistical barriers to the implementation of mHealth interventions, particularly text message interventions, for people with schizophrenia. Methods: This study examined the feasibility of leveraging personal mobile phones to deliver mHealth interventions by using data from a pilot randomized controlled trial (RCT) of a text message intervention delivered on personal mobile phones to 56 people with schizophrenia with motivation reductions. Results: Among those screened for the RCT (n =100), 91% had a mobile phone. For randomized participants (n = 56), 82.1% had a smartphone, with almost all (93.5%) having an Android processing system. Most randomized participants had unlimited text messages (96.4%) or voice calls (76.8%) with their mobile service plan, with 32.1% having unlimited data each month. At baseline, most used text messages (85.2%) and the internet (59.3%), while fewer participants used mobile applications (35.2%) at least once a week. Finally, there were no significant associations between engagement in the text message intervention and participant demographics, symptoms (positive, mood, negative), neurocognition, or mobile phone or plan characteristics or changes made during the 8 week intervention. Conclusions: Even those with schizophrenia with perceived symptom barriers to mHealth engagement (i.e., motivation reductions) may have access to mobile phones and plans and familiarity with mobile features to engage meaningfully with a text message intervention. These results help to support future implementations of text message interventions, which may enhance the provision of care for those with schizophrenia.

A systematic search and critical review of studies evaluating psychometric properties of patient-reported outcome measures for schizophrenia.

Measurement-based care (MBC) involves the regular administration of outcome assessments to track and evaluate treatment progress and requires psychometrically sound instruments. While there are widely used patient-reported outcome measures (PROMs) for several psychiatric disorders and symptom categories (e.g., depression, anxiety), there is less consensus about self-report assessments for measurement-based care of schizophrenia. The present review provides an initial guide to this area by reporting on psychometric studies that introduce or evaluate PROMs designed for the ongoing treatment of schizophrenia. Out of an initial database of 6,153 articles, and review of 141 full-text articles, an analysis of 21 articles examining 12 measures is presented in this review. Findings suggest robust options exist for clinical and research institutions aiming to assess symptom outcomes in schizophrenia, with most measures showing strengths in internal consistency, test-retest reliability, and a number of measures with evidence of convergent or criterion validity. While there exist heterogeneous options, multiple measures demonstrated promising psychometric strengths. Future work validating consistent psychometric validity could involve measures which could be valuable in context of MBC for schizophrenia.

FOCUS mHealth Intervention for Veterans With Serious Mental Illness in an Outpatient Department of Veterans Affairs Setting: Feasibility, Acceptability, and Usability Study.

BACKGROUND: Veterans with serious mental illnesses (SMIs) face barriers to accessing in-person evidence-based interventions that improve illness management. Mobile health (mHealth) has been demonstrated to be feasible, acceptable, effective, and engaging among individuals with SMIs in community mental health settings. mHealth for SMIs has not been tested within the Department of Veterans Affairs (VA). OBJECTIVE: This study examines the feasibility, acceptability, and preliminary effectiveness of an mHealth intervention for SMI in the context of VA outpatient care. METHODS: A total of 17 veterans with SMIs were enrolled in a 1-month pilot trial of FOCUS, a smartphone-based self-management intervention for SMI. At baseline and posttest, they completed measures examining symptoms and functional recovery. The participants provided qualitative feedback related to the usability and acceptability of the intervention. RESULTS: Veterans completed on an average of 85.0 (SD 96.1) interactions with FOCUS over the 1-month intervention period. They reported high satisfaction, usability, and acceptability, with nearly all participants (16/17, 94%) reporting that they would recommend the intervention to a fellow veteran. Clinicians consistently reported finding mHealth-related updates useful for informing their care. Qualitative feedback indicated that veterans thought mHealth complemented their existing VA services well and described potential opportunities to adapt FOCUS to specific subpopulations (eg, combat veterans) as well as specific delivery modalities (eg, groups). In the 1-month period, the participants experienced small improvements in self-assessed recovery, auditory hallucinations, and quality of life. CONCLUSIONS: The FOCUS mHealth intervention is feasible, acceptable, and usable among veterans. Future work should develop and examine VA-specific implementation approaches of FOCUS for this population.

Temporal Changes and Clinical Implications of Delayed Peridevice Leak Following Left Atrial Appendage Closure.

OBJECTIVES: The aim of this study was to assess temporal changes and clinical implications of peridevice leak (PDL) after left atrial appendage closure. BACKGROUND: Endocardial left atrial appendage closure devices are alternatives to long-term oral anticoagulation (OAC) for patients with atrial fibrillation. PDL >5 mm may prohibit discontinuation of OAC. METHODS: Patients included in the study had: 1) successful Watchman device implantation without immediate PDL; 2) new PDL identified at 45 to 90 days using transesophageal echocardiography; 3) eligibility for OAC; and 4) 1 follow-up transesophageal echocardiographic study for PDL surveillance. Relevant clinical and imaging data were collected by chart review. The combined primary outcome included failure to stop OAC after 45 to 90 days, transient ischemic attack or stroke, device-related thrombi, and need for PDL closure. RESULTS: Relevant data were reviewed for 1,039 successful Watchman device implantations. One hundred eight patients (10.5%) met the inclusion criteria. The average PDL at 45 to 90 days was 3.2 ± 1.6 mm. On the basis of a median PDL of 3 mm, patients were separated into ≤3 mm (n = 73) and >3 mm (n = 35) groups. In the ≤3 mm group, PDL regressed significantly (2.2 ± 0.8 mm vs 1.6 ± 1.4 mm; P = 0.002) after 275 ± 125 days. In the >3 mm group, there was no significant change in PDL (4.9 ± 1.4 mm vs 4.0 ± 3.0 mm; P = 0.12) after 208 ± 137 days. The primary outcome occurred more frequently (69% vs 34%; P = 0.002) in the >3 mm group. The incidence of transient ischemic attack or stroke in patients with PDL was significantly higher compared with patients without PDL, irrespective of PDL size. CONCLUSIONS: New PDL detected by transesophageal echocardiography at 45 to 90 days occurred in a significant percentage of patients and was associated with worse clinical outcomes. PDL ≤3 mm tended to regress over time.

A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE.

BACKGROUND: People with serious mental illness (SMI) have significant unmet mental health needs. Development and testing of digital interventions that can alleviate the suffering of people with SMI is a public health priority. OBJECTIVE: The aim of this study is to conduct a fully remote randomized waitlist-controlled trial of CORE, a smartphone intervention that comprises daily exercises designed to promote reassessment of dysfunctional beliefs in multiple domains. METHODS: Individuals were recruited via the web using Google and Facebook advertisements. Enrolled participants were randomized into either active intervention or waitlist control groups. Participants completed the Beck Depression Inventory-Second Edition (BDI-II), Generalized Anxiety Disorder-7 (GAD-7), Hamilton Program for Schizophrenia Voices, Green Paranoid Thought Scale, Recovery Assessment Scale (RAS), Rosenberg Self-Esteem Scale (RSES), Friendship Scale, and Sheehan Disability Scale (SDS) at baseline (T1), 30-day (T2), and 60-day (T3) assessment points. Participants in the active group used CORE from T1 to T2, and participants in the waitlist group used CORE from T2 to T3. Both groups completed usability and accessibility measures after they concluded their intervention periods. RESULTS: Overall, 315 individuals from 45 states participated in this study. The sample comprised individuals with self-reported bipolar disorder (111/315, 35.2%), major depressive disorder (136/315, 43.2%), and schizophrenia or schizoaffective disorder (68/315, 21.6%) who displayed moderate to severe symptoms and disability levels at baseline. Participants rated CORE as highly usable and acceptable. Intent-to-treat analyses showed significant treatment×time interactions for the BDI-II (F1,313=13.38; P<.001), GAD-7 (F1,313=5.87; P=.01), RAS (F1,313=23.42; P<.001), RSES (F1,313=19.28; P<.001), and SDS (F1,313=10.73; P=.001). Large effects were observed for the BDI-II (d=0.58), RAS (d=0.61), and RSES (d=0.64); a moderate effect size was observed for the SDS (d=0.44), and a small effect size was observed for the GAD-7 (d=0.20). Similar changes in outcome measures were later observed in the waitlist control group participants following crossover after they received CORE (T2 to T3). Approximately 41.5% (64/154) of participants in the active group and 60.2% (97/161) of participants in the waitlist group were retained at T2, and 33.1% (51/154) of participants in the active group and 40.3% (65/161) of participants in the waitlist group were retained at T3. CONCLUSIONS: We successfully recruited, screened, randomized, treated, and assessed a geographically dispersed sample of participants with SMI entirely via the web, demonstrating that fully remote clinical trials are feasible in this population; however, study retention remains challenging. CORE showed promise as a usable, acceptable, and effective tool for reducing the severity of psychiatric symptoms and disability while improving recovery and self-esteem. Rapid adoption and real-world dissemination of evidence-based mobile health interventions such as CORE are needed if we are to shorten the science-to-service gap and address the significant unmet mental health needs of people with SMI during the COVID-19 pandemic and beyond. TRIAL REGISTRATION: ClinicalTrials.gov NCT04068467; https://clinicaltrials.gov/ct2/show/NCT04068467.