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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]

Introduction: Fears of relapse in people diagnosed with schizophrenia have long been recognised as an impediment to recovery and wellbeing. However, the extent of the empirical basis for the fear of relapse concept is unclear. A systematic review is required to collate available evidence and define future research directions. Methods: A pre-registered systematic search (PROSPERO CRD42020196964) of four databases (PubMED, MEDLINE-Ovid, PsycINFO-Ovid, and Cochrane Central Register of Controlled Trials) was conducted from their inception to 05/04/2021. Results: We found nine eligible studies. Five were quantitative (4 descriptive and 1 randomised controlled trial), and four were qualitative. The available quantitative evidence suggests that fear of relapse may have concurrent positive relationships with depression (r = 0.72) and suicide ideation (r = 0.48), and negative relationship with self-esteem (r = 0.67). Qualitative synthesis suggests that fear of relapse is a complex phenomenon with behavioural and emotional components which has both direct and indirect effects on wellbeing. Conclusions: Evidence in this area is limited and research with explicit service user and carer involvement is urgently needed to develop new and/or refine existing measurement tools, and to measure wellbeing rather than psychopathology. Nonetheless, clinicians should be aware that fear of relapse exists and appears to be positively associated with depression and suicide ideation, and negatively associated with self-esteem. Fear of relapse can include fears of losing personal autonomy and/or social/occupational functioning. It appears to impact carers as well as those diagnosed with schizophrenia. [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]