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BackgroundSchizophrenia relapses are common, have profound, adverse consequences for patients and are costly to health services. Early signs interventions aim to use warning signs of deterioration to prevent full relapse. Such interventions show promise but could be further developed. This study addresses 2 developments: adding basic symptoms to checklists of conventional early signs and using a mobile phone app ExPRESS to aid early signs monitoring. ObjectiveThis study aimed to (1) design a pool of self-report items assessing basic symptoms (Basic Symptoms Checklist, BSC); (2) develop and beta test a mobile phone app (ExPRESS) for monitoring early signs, basic symptoms, and psychotic symptoms; and (3) evaluate the long-term acceptability of ExPRESS via qualitative feedback from participants in a 6-month feasibility study. MethodsThe BSC items and ExPRESS were developed and then adjusted following feedback from beta testers (n=5) with a schizophrenia diagnosis. Individuals (n=18) experiencing a relapse of schizophrenia within the past year were asked to use ExPRESS for 6 months to answer weekly questions about experiences of early signs, basic symptoms, and psychotic symptoms. At the end of follow-up, face-to-face qualitative interviews (n=16; 2 were uncontactable) explored experiences of using ExPRESS. The topic guide sought participants’ views on the following a priori themes regarding app acceptability: item content, layout, and wording; app appearance; length and frequency of assessments; worries about app use; how app use fitted with participants’ routines; and the app’s extra features. Interview transcripts were analyzed using the framework method, which allows examination of both a priori and a posteriori themes, enabling unanticipated aspects of app use experiences to be explored. ResultsParticipants’ mean age was 38 years (range 22-57 years). Responses to a priori topics indicated that long-term use of ExPRESS was acceptable; small changes for future versions of ExPRESS were suggested. A posteriori themes gave further insight into individuals’ experiences of using ExPRESS. Some reported finding it more accessible than visits from a clinician, as assessments were more frequent, more anonymous, and did not require the individual to explain their feelings in their own words. Nevertheless, barriers to app use (eg, unfamiliarity with smartphones) were also reported. Despite ExPRESS containing no overtly therapeutic components, some participants found that answering the weekly questions prompted self-reflection, which had therapeutic value for them. ConclusionsThis study suggests that apps are acceptable for long-term symptom monitoring by individuals with a schizophrenia diagnosis across a wide age range. If the potential benefits are understood, patients are generally willing and motivated to use a weekly symptom-monitoring app; most participants in this study were prepared to do so for more than 6 months. Trial RegistrationClinicalTrials.gov NCT03558529; https://clinicaltrials.gov/ct2/show/NCT03558529 (Archived by WebCite at http://www.webcitation.org/70qvtRmZY).

Background Given the rapid expansion of research into digital health interventions (DHIs) for severe mental illness (SMI; eg, schizophrenia and other psychosis diagnoses), there is an emergent need for clear safety measures. Currently, measurement and reporting of adverse events (AEs) are inconsistent across studies. Therefore, an international network, iCharts, was assembled to systematically identify and refine a set of standard operating procedures (SOPs) for AE reporting in DHI studies for SMI. Design The iCharts network comprised experts on DHIs for SMI from seven countries (United Kingdom, Belgium, Germany, Pakistan, Australia, United States, and China) and various professional backgrounds. Following a literature search, SOPs of AEs were obtained from authors of relevant studies, and from grey literature. Results A thorough framework analysis of SOPs (n = 32) identified commonalities for best practice for certain domains, along with significant gaps in others; particularly around the classification of AEs during trials, and the provision of training/supervision for research staff in measuring and reporting AEs. Several areas which could lead to the observed inconsistencies in AE reporting and handling were also identified. Conclusions The iCharts network developed best-practice guidelines and a practical resource for AE monitoring in DHI studies for psychosis, based on a systematic process which identified common features and evidence gaps. This work contributes to international efforts to standardize AE measurement and reporting in this emerging field, ensuring that safety aspects of DHIs for SMI are well-studied across the translational pathway, with monitoring systems set-up from the outset to support safe implementation in healthcare systems. [ABSTRACT FROM AUTHOR]

Background Digital health interventions (DHIs) have significant potential to upscale treatment access to people experiencing psychosis but raise questions around patient safety. Adverse event (AE) monitoring is used to identify, record, and manage safety issues in clinical trials, but little is known about the specific content and context contained within extant AE reports. This study aimed to assess current AE reporting in DHIs. Study Design A systematic literature search was conducted by the iCharts network (representing academic, clinical, and experts by experience) to identify trials of DHIs in psychosis. Authors were invited to share AE reports recorded in their trials. A content analysis was conducted on the shared reports. Study Results We identified 593 AE reports from 18 DHI evaluations, yielding 19 codes. Only 29 AEs (4.9% of total) were preidentified by those who shared AEs as being related to the intervention or trial procedures. While overall results support the safety of DHIs, DHIs were linked to mood problems and psychosis exacerbation in a few cases. Additionally, 27% of studies did not report information on relatedness for all or at least some AEs; 9.6% of AE reports were coded as unclear because it could not be determined what had happened to participants. Conclusions The results support the safety of DHIs, but AEs must be routinely monitored and evaluated according to best practice. Individual-level analyses of AEs have merit to understand safety in this emerging field. Recommendations for best practice reporting in future studies are provided. [ABSTRACT FROM AUTHOR]

Background Ecological momentary assessment (EMA) involves completing multiple surveys over time in daily life, capturing in-the-moment experiences in real-world contexts. EMA use in psychosis studies has surged over several decades. To critically examine EMA use in psychosis research and assist future researchers in designing new EMA studies, this systematic review aimed to summarize the methodological approaches used for positive symptoms in psychosis populations and evaluate feasibility with a focus on completion rates. Methods A systematic review of PubMed, PsycINFO, MEDLINE, Web of Science, EBSCOhost, and Embase databases using search terms related to EMA and psychosis was conducted. Excluding duplicate samples, a meta-analysis was conducted of EMA survey completion rates and meta-regression to examine predictors of completion. Results Sixty-eight studies were included in the review. Characteristics and reporting of EMA methodologies were variable across studies. The meta-mean EMA survey completion computed from the 39 unique studies that reported a mean completion rate was 67.15% (95% CI = 62.3, 71.9), with an average of 86.25% of the sample meeting a one-third EMA completion criterion. No significant predictors of completion were found in the meta-regression. A variety of EMA items were used to measure psychotic experiences, of which few were validated. Conclusions EMA methods have been widely applied in psychosis studies using a range of protocols. Completion rates are high, providing clear evidence of feasibility in psychosis populations. Recommendations for reporting in future studies are provided. [ABSTRACT FROM AUTHOR]

Individuals with psychosis report favourable attitudes towards psychological interventions delivered via smartphone apps. Evidence for acceptability, safety, feasibility and efficacy is promising but in-depth reporting of app engagement in trials is sparse. To examine how people with psychosis engaged with the cognitive behaviour therapy (CBT)-informed Actissist app over a 12-week intervention period, and to examine factors associated with app engagement. Secondary data from participants in the intervention arm (n = 24) of a proof-of-concept randomised controlled trial of the Actissist app were analysed. The app prompted participants to engage with app-based CBT-informed material in five domains (voices, socialization, cannabis use, paranoia, perceived criticism) at pseudo-random intervals (three notifications per day, six days per week). Participants could self-initiate use any time. App use was financially incentivised. Participants responded to 47% of app notifications. Most app engagements (87%) were app-initiated rather than self-initiated. Participants engaged most with the voices domain, then paranoia. Age and employment status were significantly associated with overall app engagement. Individuals with psychosis engaged well with Actissist, particularly with areas focussing on voice-hearing and paranoia. App-generated reminders successfully prompted app engagement. As financial incentives may have increased app engagement, future studies of non-incentivized engagement in larger samples are needed. [ABSTRACT FROM AUTHOR]

Video consultations are increasingly used to communicate with patients, particularly during the current COVID-19 pandemic. However, training in video consultation skills receives scant attention in the literature. We sought to introduce this important topic to our undergraduate medical school curriculum. To increase final year medical students' video consultation skills and knowledge. We used Plan, Do, Study, Act (PDSA) quality improvement methodology with a pre-post study design to develop a teaching session for 5th year medical students, informed by a literature review and online clinician survey. The 2 hour session comprised an introduction and three practical stations: patient selection and ethics, technology and example videos, and simulation. Subjective pre- and post-session confidence was reported by students across seven domains using 5-point scales (1: not at all confident; 5: extremely confident). Students and facilitators completed post-session feedback forms. The 40 students and 3 facilitators who attended, over two separate teaching sessions, provided unanimously positive feedback. All students considered the session relevant. Subjective confidence ratings (n = 34) significantly increased from pre- to post-session (mean increase 1.78, p < 0.001). The inaugural teaching session was well-received and subjective assessment measures showed improvement in taught skills. This pilot has informed a UK-wide multi-centre study with subjective and objective data collection. [ABSTRACT FROM AUTHOR]

Background: The National Institute for Clinical Excellence (NICE) guidelines recommend that individual cognitive-behaviour therapy (CBT) is offered to all people with a diagnosis of schizophrenia. In addition, the guidelines recommend that family intervention (FI) should be offered to all families of people with schizophrenia who are in close contact with the service user. However, implementation into routine services is poor. Aims: To survey mental health services to investigate how many people with a diagnosis of schizophrenia and their families are offered and receive CBT or FI. Methods: A comprehensive audit of a random sample of 187 service users receiving care from one, large mental health care trust in North West England was conducted over a 12-month period. Results: The audit recorded that only 13 (6.9%) of services users were offered and 10 (5.3%) received individual CBT, while 3 (1.6%) services users were offered and 2 (1.1%) received FIs within the 12-month audit period. Conclusions: Implementation of CBT and FI is poor, particularly for FI. Reasons for poor implementation and service implications are discussed. [ABSTRACT FROM AUTHOR]

Background: Early signs based relapse prevention interventions for psychosis show promise. In order to examine how they might be improved we sought to better understand the early relapse process, service users’ abilities to identify early signs, and any potential facilitators and barriers to early signs interventions. Methods: Data from in-depth interviews with a convenience sample of service users with psychosis varying in gender, age, duration of mental health problems, and time since last relapse were analysed using a thematic approach. Interview transcripts were coded inductively and relationships between emerging themes were examined by the research team to provide a thorough synthesis of the data. Results: Three central themes emerged from the analysis: 1) recognising risk factors (how risk factors were identified and linked to relapse, and reactions to such risk factors); 2) identifying early signs (issues related to both recognising and recalling signs of relapse); 3) reacting to deterioration (participants’ thoughts and feelings in response to early signs, including help seeking and its challenges). Conclusions: There was considerable variation in the attention participants had paid to pre-relapse signs, the ease with which they were able to recall them, and their reactions to them. For many, there were substantial barriers to help seeking from services. A family or friend confidant was an important means of assistance, although the supportive presence of significant others was not always available. Based on these results, a number of recommendations about facilitating service users’ recognition of early signs and targeting potential accelerants of relapse are made. [ABSTRACT FROM AUTHOR]

Background Psychosis relapses are common, have profound adverse consequences for patients, and are costly to health services. 'Early signs' have been used to predict relapse, in the hope of prevention or mitigation, with moderate sensitivity and specificity. To improve predictive power, we investigated adding 'basic symptoms' to conventional early signs and using a smartphone app to facilitate prompt identification of these. Methods Individuals who had experienced a relapse of psychosis within the past year (n=22) took part in a screening interview. Those with at least one basic symptom emerging prior to a previous relapse (n=19; 86%) were eligible for the longitudinal feasibility study. Consenting participants (n=18) were asked to use a smartphone app ('ExPRESS') weekly for six months to report early signs, basic symptoms and psychotic symptoms. When app responses indicated an increase in psychotic symptoms above a pre-defined threshold, the researcher conducted the PANSS positive symptoms interview over the telephone to assess whether the symptom increase was indicative of relapse (in combination with a management change, evidenced by casenote review). On completion of, or dropout from, the app-use phase, participants were invited to give their views on the acceptability of the app and study procedures in a qualitative interview. Results Participants completed 65% of app assessments and 58% of telephone interviews over the 6-month follow-up period. Completion of app assessments declined as the study progressed (OR=0.89 per week follow-up; p<0.001). Percentage app completion was significantly and inversely correlated with baseline depression (ρ=-0.56, p=0.015) and fear of relapse (ρ=-0.58, p=0.014). App items showed high concurrent validity with researcher-rated psychotic symptoms (ρ range 0.80 to 0.87, p<0.001) and basic symptoms (ICC=0.76, p<0.001) over six months. There was excellent agreement between telephone call and face-to-face assessed psychotic symptoms (ICC range 0.94 to 0.96, p<0.001). The primary relapse definition, based on telephone assessment and casenotes, compared well with a casenote-only definition but had better specificity (κ=0.76, p=0.003). Mixed-effects models (>200 observations) provided preliminary evidence of predictive validity: early signs and basic symptoms were associated with most app-assessed psychotic symptom variables the same week and three weeks later and adding basic symptoms to early signs improved model fit in most cases. Qualitative interviews indicated that both the app and study procedures were acceptable to patients with psychosis. Discussion This study demonstrates that weekly app-based monitoring is feasible, valid and acceptable over a six-month period. It also provides a novel approach to operationally defining relapse by using a combination of telephone interviews and casenotes. We suggest that remote relapse assessment is more easily integrated into participants' everyday lives, decreasing both participant and researcher burden; this is likely to increase engagement and allow more frequent and long-term monitoring. [ABSTRACT FROM AUTHOR]

Surface sampling for SARS-CoV-2 RNA detection has shown considerable promise to detect exposure of built environments to infected individuals shedding virus who would not otherwise be detected. Here, we compare two popular sampling media (VTM and SDS) and two popular workflows (Thermo and PerkinElmer) for implementation of a surface sampling program suitable for environmental monitoring in public schools. We find that the SDS/Thermo pipeline shows superior sensitivity and specificity, but that the VTM/PerkinElmer pipeline is still sufficient to support surface surveillance in any indoor setting with stable cohorts of occupants (e.g., schools, prisons, group homes, etc.) and may be used to leverage existing investments in infrastructure. IMPORTANCE The ongoing COVID-19 pandemic has claimed the lives of over 5 million people worldwide. Due to high density occupancy of indoor spaces for prolonged periods of time, schools are often of concern for transmission, leading to widespread school closings to combat pandemic spread when cases rise. Since pediatric clinical testing is expensive and difficult from a consent perspective, we have deployed surface sampling in SASEA (Safer at School Early Alert), which allows for detection of SARS-CoV-2 from surfaces within a classroom. In this previous work, we developed a high-throughput method which requires robotic automation and specific reagents that are often not available for public health laboratories such as the San Diego County Public Health Laboratory (SDPHL). Therefore, we benchmarked our method (Thermo pipeline) against SDPHL's (PerkinElmer) more widely used method for the detection and prediction of SARS-CoV-2 exposure. While our method shows superior sensitivity (false-negative rate of 9% versus 27% for SDPHL), the SDPHL pipeline is sufficient to support surface surveillance in indoor settings. These findings are important since they show that existing investments in infrastructure can be leveraged to slow the spread of SARS-CoV-2 not in just the classroom but also in prisons, nursing homes, and other high-risk, indoor settings.

A promising approach to help students safely return to in person learning is through the application of sentinel cards for accurate high resolution environmental monitoring of SARS-CoV-2 traces indoors. Because SARS-CoV-2 RNA can persist for up to a week on several indoor surface materials, there is a need for increased temporal resolution to determine whether consecutive surface positives arise from new infection events or continue to report past events. Cleaning sentinel cards after sampling would provide the needed resolution but might interfere with assay performance. We tested the effect of three cleaning solutions (BZK wipes, Wet Wipes, RNase Away) at three different viral loads: "high" (4 × 10 4 GE/mL), "medium" (1 × 10 4 GE/mL), and "low" (2.5 × 10 3 GE/mL). RNase Away, chosen as a positive control, was the most effective cleaning solution on all three viral loads. Wet Wipes were found to be more effective than BZK wipes in the medium viral load condition. The low viral load condition was easily reset with all three cleaning solutions. These findings will enable temporal SARS-CoV-2 monitoring in indoor environments where transmission risk of the virus is high and the need to avoid individual-level sampling for privacy or compliance reasons exists. IMPORTANCE Because SARS-CoV-2, the virus that causes COVID-19, persists on surfaces, testing swabs taken from surfaces is useful as a monitoring tool. This approach is especially valuable in school settings, where there are cost and privacy concerns that are eliminated by taking a single sample from a classroom. However, the virus persists for days to weeks on surface samples, so it is impossible to tell whether positive detection events on consecutive days are a persistent signal or new infectious cases and therefore whether the positive individuals have been successfully removed from the classroom. We compare several methods for cleaning "sentinel cards" to show that this approach can be used to identify new SARS-CoV-2 signals day to day. The results are important for determining how to monitor classrooms and other indoor environments for SARS-CoV-2 virus.

Monitoring severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on surfaces is emerging as an important tool for identifying past exposure to individuals shedding viral RNA. Our past work demonstrated that SARS-CoV-2 reverse transcription-quantitative PCR (RT-qPCR) signals from surfaces can identify when infected individuals have touched surfaces and when they have been present in hospital rooms or schools. However, the sensitivity and specificity of surface sampling as a method for detecting the presence of a SARS-CoV-2 positive individual, as well as guidance about where to sample, has not been established. To address these questions and to test whether our past observations linking SARS-CoV-2 abundance to Rothia sp. in hospitals also hold in a residential setting, we performed a detailed spatial sampling of three isolation housing units, assessing each sample for SARS-CoV-2 abundance by RT-qPCR, linking the results to 16S rRNA gene amplicon sequences (to assess the bacterial community at each location), and to the Cq value of the contemporaneous clinical test. Our results showed that the highest SARS-CoV-2 load in this setting is on touched surfaces, such as light switches and faucets, but a detectable signal was present in many untouched surfaces (e.g., floors) that may be more relevant in settings, such as schools where mask-wearing is enforced. As in past studies, the bacterial community predicts which samples are positive for SARS-CoV-2, with Rothia sp. showing a positive association. IMPORTANCE Surface sampling for detecting SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), is increasingly being used to locate infected individuals. We tested which indoor surfaces had high versus low viral loads by collecting 381 samples from three residential units where infected individuals resided, and interpreted the results in terms of whether SARS-CoV-2 was likely transmitted directly (e.g., touching a light switch) or indirectly (e.g., by droplets or aerosols settling). We found the highest loads where the subject touched the surface directly, although enough virus was detected on indirectly contacted surfaces to make such locations useful for sampling (e.g., in schools, where students did not touch the light switches and also wore masks such that they had no opportunity to touch their face and then the object). We also documented links between the bacteria present in a sample and the SARS-CoV-2 virus, consistent with earlier studies.

Objectives: To evaluate the effectiveness of integrated motivational interviewing and cognitive behavioural therapy in addition to standard care for patients with psychosis and a comorbid substance use problem., Design: Two centre, open, rater blind randomised controlled trial., Setting: Secondary care in the United Kingdom., Participants: 327 patients with a clinical diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder and a diagnosis of dependence on or misuse of drugs, alcohol, or both according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition., Intervention: The intervention was integrated motivational interviewing and cognitive behavioural therapy plus standard care, which was compared with standard care alone. Phase one of therapy-"motivation building"-concerns engaging the patient, then exploring and resolving ambivalence for change in substance use. Phase two-"action"-supports and facilitates change using cognitive behavioural approaches. Up to 26 therapy sessions were delivered over one year., Main Outcome Measures: The primary outcome was death from any cause or admission to hospital in the 12 months after completion of therapy. Secondary outcomes were frequency and amount of substance use (assessed using the timeline followback method), readiness to change, perceived negative consequences of use, psychotic symptom ratings, number and duration of relapses, and global assessment of functioning and deliberate self harm at 12 and 24 months, with additional timeline followback assessments at 6 and 18 months. Analysis was by intention to treat and robust treatment effect estimates were produced., Results: 327 participants were randomly allocated to either the intervention (n=164) or treatment as usual (n=163). At 24 months, 326 (99.7%) were assessed on the primary outcome and 246 (75.2%) on the main secondary outcomes. Treatment had no beneficial effect on hospital admissions or death during follow-up, with 23.3% (38/163) of the therapy group and 20.2% (33/163) of controls deceased or admitted (adjusted odds ratio 1.16, 95% confidence interval 0.68 to 1.99; P=0.579). Therapy had no effect on the frequency of substance use or the perceived negative consequences of misuse, but did have a statistically significant effect on amount used per substance using day (adjusted ORs for main substance 1.50, 95% CI 1.08 to 2.09; P=0.016; and all substances 1.48, 95% CI 1.07 to 2.05; P=0.017). Treatment had a statistically significant effect on readiness to change use at 12 months (adjusted OR 2.05, 95% CI 1.26 to 3.31; P=0.004) that was not maintained at 24 months (0.78, 95% CI 0.48 to 1.28; P=0.320). There were no effects of treatment on clinical outcomes such as relapses, psychotic symptoms, functioning, and self harm., Conclusions: Integrated motivational interviewing and cognitive behavioural therapy for people with psychosis and substance misuse do not improve outcome in terms of hospitalisation, symptom outcomes, or functioning. This approach does reduce the amount of substance used for at least one year after completion of therapy., Trial Registration: Current Controlled Trials: ISRCTN14404480.