Matteo Cella

Background: Digital health interventions for psychosis, like SloMo, leverage smartphone technology to help transfer learning from therapy to real-life situations. Usage relies on motivation, recall, and awareness. Wearable devices that track physiological signs of stress can boost engagement by encouraging the use of coping strategies when most needed. Objective: This study aims to co-design an integrated user interface for wearable technology and the SloMo mobile app, and explore its usability, acceptability, engagement, and preliminary clinical outcomes for individuals with psychosis through a feasibility study. Methods: A co-design team developed the wearable augmented SloMo app using the Double Diamond framework. The team included 10 experts by experience based across three UK National Health Service (NHS) mental health trusts, who had completed SloMo as part of a randomized controlled trial, and were purposively recruited to ensure a range of demographic backgrounds. Users tested the app for 8 consecutive weeks during a 5-month data collection period in 2018, providing feedback that guided iterative improvements. Self-reported engagement, usability, and acceptability were collected through quantitative ratings and interviews, evaluated through qualitative content analysis. Assessments of paranoia and well-being were completed pre- and post use, summarized descriptively, with change scores calculated and evaluated for reliable change. Results: The Spire Stone clothing-adhered biosensor, which monitors respiratory rate and stress physiology, was chosen to augment SloMo. A minimum viable product of an integrated interface was developed. Feedback identified that users needed the technology to be easy to use, secure, and tailored to them through user control. Eight (8/10, 80%) users reported that the wearable prompted increased use of the SloMo app’s features and other coping strategies. Self-reported engagement varied according to EBE user experience of the technology: higher use of the technology (n=3) was associated with higher usefulness (25% reduction in paranoia, SD 6%) and acceptability (84% satisfaction, SD 13%). Conversely, individuals that engaged with the device less (n=7) did not find it as useful (11% increase in paranoia, SD 17%) and were only modestly satisfied (63%, SD 20%). Conclusions: Wearable technology is acceptable and can be integrated with a digitally supported therapy for psychosis to promote engagement and potentially support management of difficulties. However, further development work is needed to ensure acceptability and usefulness across a broader range of user needs.

Background and Hypotheses: The brain continuously generates predictions about future experiences. When outcomes deviate from expectations, positive (+RPE) and negative (-RPE) reward prediction errors recalibrate predictions. Neuroimaging evidence indicates that amotivation in schizophrenia-spectrum disorders (SSD) is linked to blunted processing of +RPEs. Yet the nature of RPEs and their processing in the everyday lives of people with SSD remains unknown. Study Design: This preregistered analysis pooled data from two studies (N = 147; SSD = 68, healthy controls [HC] = 79) to quantify daily-life +RPEs and -RPEs and test their association with subsequent updating of anticipatory pleasure. Participants completed six days of ecological momentary assessment capturing current and anticipated pleasure. +RPEs were defined as EMA assessments in which current pleasure exceeded anticipated pleasure at the previous prompt, –RPEs were defined as occasions in which current pleasure fell short of prior anticipation. Linear mixed-effects models tested group differences in RPE frequency and magnitude; time-lagged models assessed updating of anticipatory pleasure. Study Results: Individuals with SSD reported fewer +RPEs (β = –0.05, p = .025), with no group difference in -RPEs or RPE magnitude. Within SSD, higher baseline amotivation was associated with smaller +RPEs (β = –0.08, p = .019). Time-lagged analyses revealed that in SSD, larger +RPEs predicted reduced subsequent anticipatory pleasure (β = –.171, p < .001), unlike in HCs (β = –.038, p = .26). Conclusions: Findings indicate that in everyday life, individuals with SSD experience fewer positive surprises and show maladaptive updating of reward expectations, potentially driving negative symptoms.

Digital remote monitoring technologies, including smartphones and wearables, offer promising avenues for early detection of psychosis relapse. However, selecting devices that are acceptable to participants and produce high-quality data remains challenging. The aim of this nested pilot study was to assess the acceptability and data quality of 3 commercially available wearable devices in people with psychosis recruited to the CONNECT cohort study. Participants recruited to the CONNECT study before July 31, 2024, were included in the pilot study and selected 1 of 3 wearable devices: a Fitbit Charge 5, Samsung Galaxy Watch 5, or Apple Watch SE. Baseline demographics were compared between device groups. Acceptability of devices to participants was assessed through a Wearable Device Satisfaction Questionnaire after 3 months of use, with the proportion of positive responses to each question calculated and compared. Data completeness was also assessed by calculating the number (and percentage) of valid days of step count, heart rate, and sleep data, and comparing between groups. Data quality was assessed through summarizing the amount of troubleshooting required, additional metrics available from the wearables, and continuity of data completeness by calculating the proportion of participants with at least 3 days of heart rate data per week for the first 20 weeks of follow-up. Predefined criteria were used to determine the next steps for the wider CONNECT study: if one device was superior, this would be selected; if none were found to be superior and the Fitbit was found to be noninferior, then Fitbit would be retained. Of the first 107 participants recruited to CONNECT, 105 were included in the pilot study evaluation. The Samsung Galaxy Watch was selected most frequently by participants (46/105, 43.8%), followed by the Apple Watch (27/105, 25.7%), and Fitbit Charge (23/105, 21.9%). Differences in participant demographics were observed across device groups. Self-reported acceptability after use did not differ substantially between devices. However, in terms of data completeness, the median proportion of valid heart rate data days was significantly lower for Samsung Galaxy (median 31.2%, IQR 8.5%-46.0%) compared to Fitbit (median 80.1%, IQR 26.7%-95.0%; P=.003) and Apple Watch (median 49.3%, IQR 21.5%-86.0%; P=.02). There was no significant difference between Fitbit and Apple Watch. Similar patterns were observed for step count and sleep data. The Samsung Galaxy Watch required more frequent troubleshooting for data flow issues and lacked additional physiological metrics, available from the other devices. Due to comparatively lower data quality and technical performance, the Samsung Galaxy Watch was discontinued for use in the subsequent phase of the CONNECT study. The study highlights the importance of incorporating nested evaluations of devices in long-term research.

Purpose: Cognitive difficulties are commonly present in people with psychosis and are associated with poor functional outcomes. Evidence from high-income countries (HICs) indicates that cognitive remediation (CR) is an effective treatment for cognitive difficulties. Evidence from low and middle-income countries (LAMICs) is emerging. This study reviews the evidence for CR for people with psychosis in LAMICs. Methods: Seven databases (GIM, SCOPUS, WoS, APA PsycINFO, Global Health, Medline(R), and Embase) were searched. Two reviewers screened the studies retrieved independently against the eligibility criteria. Risk of bias was assessed using ROB 2.0 and ROBINS-I. The results on CR efficacy, alongside application and delivery, were synthesised narratively. Results: Fourteen studies from countries in Africa, Asia and South America were included. CR delivery modality and settings varied, including those delivered at home and by caregivers and health care workers. Thirteen studies showed that CR was beneficial for cognition, with small to large effect sizes. Nine studies showed that CR can improve functioning, with small to moderate effect sizes. The studies showed that CR was safe and well-tolerated. The effect of CR did not differ by setting, dosage, delivery agent or mode of delivery. Conclusions: CR could be a useful approach to reduce the burden of cognitive difficulties in people with psychosis in LAMIC. The adaptations to CR evaluated by the included studies could be used and further evaluated globally to provide novel, culturally acceptable and scalable implementation approaches for CR.

Background: Anhedonia (loss of pleasure) is a core feature of both depression and psychosis and yet the experience is not well understood. This limits our ability to effectively target it with psychological or pharmacological interventions. Aims: The aim of this study was to explore the experience of anhedonia, for the first time from a transdiagnostic perspective. Method: Semi-structured interviews, co-facilitated by lived-experience experts, were conducted among 17 adults with a diagnosis of depression or psychosis and who were experiencing anhedonia. Reflexive thematic analysis was employed to generate themes. Results: Six themes were identified: (a) no longer experiencing pleasure or joy in previously enjoyable activities; (b) grieving for the joyful times that have been missed; (c) the dilemma before trying an activity again; (d) the significant social impact of anhedonia, and the power of lived-experience connections; (e) uncertainty around what causes anhedonia; and (f) the lack of acknowledgement or support from services around this experience. The words disconnection and frustration were those most used to describe what people felt when experiencing anhedonia. Conclusions: The results highlight the negative impact of expectation and social pressure on joy, and the importance of the anticipatory period prior to trying an activity again. The clinical implications highlight the importance of discussing anhedonia with patients: by not doing so is contributing to stigma. This is the first study to directly explore anhedonia in adults, with lived-experience input throughout, and the findings support further work adopting a wider transdiagnostic approach.

Background and Hypothesis: Trials rarely include outcomes co-developed with stakeholders, which creates uncertainty about whether trial endpoints reflect the benefits valued by patients and clinicians. There is therefore a need to explore how stakeholder perspectives might influence the interpretation of trial results. Study Design: In a 2-phase study, we first engaged service users and staff to rank outcomes from a recently completed randomized controlled trial of cognitive remediation therapy (CRT). We then used multi-criteria decision modelling to generate value-weighted composite scores and reanalyzed the trial data from three arms: individual CRT, group CRT, and treatment as usual (TAU). This approach allowed us to examine how weighting outcomes differently, according to stakeholder perspectives, might affect the conclusions drawn from the trial. Study Results: Both stakeholder groups prioritized the Global Assessment Scale (primary outcome) and quality of life, but disagreed on the importance of cognition. Reanalyses using weighted composite scores produced the same robust finding as the original trial: CRT delivered in group or one-to-one formats provides significant benefit compared with TAU. Sensitivity analyses applying different stakeholder weights showed the same pattern. However, exploratory analyses revealed that group treatment for the service user weighted composite was not significant. Conclusions: This study shows how stakeholder values can identify nuances in outcomes depending on the value placed on treatment benefits. Embedding this approach into trial design can strengthen the alignment of outcomes with patient and service priorities and help close the gap between randomized trials and service implementation.

Background: Preventing relapses of psychosis is difficult and important. Digital remote monitoring (DRM) systems are being developed and tested to support this. Increasingly, these systems use algorithm-based relapse prediction. Hence, understanding stakeholder views about algorithmic prediction is crucial. Existing qualitative work has explored health professionals’ views, but very few studies have examined the perspectives of people with psychosis on this topic. Objective: This paper aimed to provide an in-depth examination of the views of people with psychosis regarding algorithmic relapse prediction within a DRM system that incorporates active symptom monitoring and passive sensing data. Methods: People with psychosis (n=58) were recruited from 6 geographically distinct areas of the United Kingdom. They participated in semistructured qualitative interviews exploring their views about using a DRM system that predicts psychosis relapse based on a machine learning algorithm. Transcripts were analyzed using reflexive thematic analysis. People with lived experience of psychosis were involved extensively in study design, analysis, and reporting. Results: Findings were described across 4 themes. First, accuracy was a prominent theme. Participants emphasized that transparency about algorithm sensitivity and specificity is crucial and discussed the risks of the relapse prediction algorithm producing false positives (flagging that someone was relapsing when they were not) and false negatives (missing actual relapses). In both cases, participants said that errors may be partially mitigated through a human-in-the-loop approach (theme 2), with DRM blended with human oversight, from clinicians or a dedicated digital monitoring team, and calibrated based on service user, carer, and clinician feedback. The third theme, trust, fears, and choice, noted the interplay between users’ trust in the DRM system and their relationship with the clinical team. This theme described participants’ fears about potential overreactions (hospitalization or excessive medication) or underreactions (no additional support) from the clinical team in response to algorithm-generated relapse predictions. It emphasized the importance of retaining choice around the use of relapse detection algorithms and the sharing of personal data. The final theme described participants’ views about the benefits of using a relapse prediction algorithm , including facilitating early intervention, triaging care according to need, minimizing human bias in assessment, and efficiency in saving staff time. Conclusions: People with psychosis acknowledged potential benefits of algorithm-assisted relapse prediction for receiving timely or efficient care, but with several caveats. Algorithm-generated relapse alerts need to be sufficiently accurate and must be interpreted, with understanding of their limitations, by a trustworthy human who is aware of the relevant context. Algorithm-based relapse predictions should only be used with valid consent, in a way that promotes and respects the autonomy and voice of service users and avoids increasing the use of excessive restriction.

BACKGROUND Digital health interventions for psychosis, like SloMo, leverage smartphone technology to help transfer learning from therapy to real-life situations. Usage relies on motivation, recall, and awareness. Wearable devices that track physiological signs of stress can boost engagement by encouraging the use of coping strategies when most needed. OBJECTIVE To co-design an integrated user interface for wearable technology and the SloMo mobile app, and to validate its usefulness, usability, and acceptability to individuals with psychosis. METHODS A co-design team, including 10 experts by experience, developed the wearable augmented SloMo app using the Double Diamond framework. Users tested the app for 8 consecutive weeks, providing feedback that guided iterative improvements. User experience ratings and assessments of the technology's potential to reduce paranoia and improve wellbeing were collected pre- and post-use. RESULTS The Spire Stone clothing-adhered biosensor, which monitors respiratory rate and stress physiology, was chosen to augment SloMo. A minimum viable product of an integrated interface was developed. Feedback identified that users needed the technology to be easy to use, secure and tailored to them through user control. Eighty percent of users reported that the wearable prompted increased use of the SloMo app’s features and other coping strategies. Engagement levels and experience varied: those who used the technology most reported improvements to paranoia and high satisfaction. Conversely, individuals that engaged with the device less experienced slight increases in paranoia and were only modestly satisfied. CONCLUSIONS Wearable technology is generally acceptable and can augment a digitally-supported therapy for psychosis and promote engagement. However, further development work is needed for the technology to be acceptable and useful to a broader range of people. CLINICALTRIAL SloMo Trial Registration: ISRCTN 32448671

Background: Relapses result in negative consequences for individuals with psychosis and considerable health service costs. Digital remote monitoring (DRM) systems incorporating “passive sensing” (sensor data gathered via smartphones/wearables) may be a low-burden method for identifying relapses early, enabling prompt intervention and potentially averting the consequences of full relapse. Objective: This study examined detailed views from people with psychosis about using passive sensing in this context. Study Design: Qualitative interviews, analyzed using reflexive thematic analysis. Setting: Secondary care mental health services across the United Kingdom. An advisory group with relevant lived experience was involved throughout, from developing the topic guide to analysis. Participants: Clinician confirmed diagnosis of schizophrenia-spectrum psychosis (n = 58). Study Results: Four overarching themes were developed. Theme 1 outlined participants’ polarized feelings about passive sensing, highlighting specific challenges relating to privacy, especially regarding location data. Theme 2 examined participants’ fears that clinicians might judge their movements or routines, creating a sense of pressure to modify their actions and undermining their autonomy. Theme 3 described potential solutions: offering users choice about what data are shared, when, and with whom. Theme 4 outlined specific benefits that participants valued, including intended functions of passive sensing within DRM (ease of use, early identification of relapse, and relevance of sleep monitoring) and novel uses. Conclusions: Our findings underline the importance of fully informed consent, choice, and autonomy. Given the potential privacy impacts, individuals are unlikely to engage with passive sensing unless they perceive clear personal benefits. Prospective DRM users need clear, accessible information about passive data collection and its relevant costs and benefits.

UNSTRUCTURED The influence of a positive therapeutic alliance on treatment success is well-established in psychotherapy. The emergence of digital therapeutics raises new questions about how therapeutic relationships function without human therapists. This commentary examines recent research demonstrating that individuals with schizophrenia can form and maintain a meaningful therapeutic alliance with digital interventions. It discusses the methodological approach, clinical implications, and future directions, while also situating digital alliance within the evolving landscape of human-technology interactions.