Adverse Events Reporting in Digital Interventions Evaluations for Psychosis: A Systematic Literature Search and Individual Level Content Analysis of Adverse Event Reports.

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.

Methodological Characteristics and Feasibility of Ecological Momentary Assessment Studies in Psychosis: a Systematic Review and Meta-Analysis.

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.

A Personalized, Transdiagnostic Smartphone Intervention (Mello) Targeting Repetitive Negative Thinking in Young People With Depression and Anxiety: Pilot Randomized Controlled Trial.

BACKGROUND: Repetitive negative thinking (RNT) is a key transdiagnostic mechanism underpinning depression and anxiety. Using "just-in-time adaptive interventions" via smartphones may disrupt RNT in real time, providing targeted and personalized intervention. OBJECTIVE: This pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary clinical outcomes and mechanisms of Mello-a fully automated, personalized, transdiagnostic, and mechanistic smartphone intervention targeting RNT in young people with depression and anxiety. METHODS: Participants with heightened depression, anxiety, and RNT were recruited via social media and randomized to receive Mello or a nonactive control over a 6-week intervention period. Assessments were completed via Zoom sessions at baseline and at 3 and 6 weeks after baseline. RESULTS: The findings supported feasibility and acceptability, with high rates of recruitment (N=55), uptake (55/64, 86% of eligible participants), and retention (52/55, 95% at 6 weeks). Engagement was high, with 90% (26/29) and 59% (17/29) of the participants in the Mello condition still using the app during the third and sixth weeks, respectively. Greater reductions in depression (Cohen d=0.50), anxiety (Cohen d=0.61), and RNT (Cohen d=0.87) were observed for Mello users versus controls. Mediation analyses suggested that changes in depression and anxiety were accounted for by changes in RNT. CONCLUSIONS: The results indicate that mechanistic, targeted, and real-time technology-based solutions may provide scalable and effective interventions that advance the treatment of youth mental ill health. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12621001701819; http://tinyurl.com/4d3jfj9f.

Using EMPOWER in daily life: a qualitative investigation of implementation experiences.

BACKGROUND: Digital self-management tools blended with clinical triage and peer support have the potential to improve access to early warning signs (EWS) based relapse prevention in schizophrenia care. However, the implementation of digital interventions in psychosis can be poor. Traditionally, research focused on understanding how people implement interventions has focused on the perspectives of mental health staff. Digital interventions are becoming more commonly used by patients within the context of daily life, which means there is a need to understand implementation from the perspectives of patients and carers. METHODS: Semi-structured one-on-one interviews with 16 patients who had access to the EMPOWER digital self-management intervention during their participation in a feasibility trial, six mental health staff members who supported the patients and were enrolled in the trial, and one carer participant. Interviews focused on understanding implementation, including barriers and facilitators. Data were coded using thematic analysis. RESULTS: The intervention was well implemented, and EMPOWER was typically perceived positively by patients, mental health staff and the carer we spoke to. However, some patients reported negative views and reported ideas for intervention improvement. Patients reported valuing that the app afforded them access to things like information or increased social contact from peer support workers that went above and beyond that offered in routine care. Patients seemed motivated to continue implementing EMPOWER in daily life when they perceived it was creating positive change to their wellbeing, but seemed less motivated if this did not occur. Mental health staff and carer views suggest they developed increased confidence patients could self-manage and valued using the fact that people they support were using the EMPOWER intervention to open up conversations about self-management and wellbeing. CONCLUSIONS: The findings from this study suggest peer worker supported digital self-management like EMPOWER has the potential to be implemented. Further evaluations of these interventions are warranted, and conducting qualitative research on the feasibility gives insight into implementation barriers and facilitators, improving the likelihood of interventions being usable. In particular, the views of patients who demonstrated low usage levels would be valuable.

Integrating digital interventions with clinical practice in youth mental health services.

OBJECTIVE: Integrating digital technologies with clinical practice promises to improve access and enhance care in the context of high service demand and constrained capacity. METHOD: We outline the emerging research in the integration of digital tools in clinical care, known as blended care, and provide case examples of mental health technology platforms currently in use, summarise findings regarding novel technologies such as virtual reality, and outline real-world implementation challenges and potential solutions. RESULTS: Recent evidence shows that blended care approaches are clinically effective and improve service efficiency. Youth-specific technologies such as moderated online social therapy (MOST) are achieving a range of positive clinical and functional outcomes, while emerging technologies like virtual reality have strong evidence in anxiety disorder, and accumulating evidence in psychotic conditions. Implementation science frameworks show promise in helping overcome the common challenges faced in real-world adoption and ongoing use. CONCLUSION: The integrated, blended use of digital mental health technologies with face-to-face clinical care has the potential to improve care quality for young people while helping overcome the growing challenges faced by youth mental health service providers.

The impact of COVID-19 on youth mental health: A mixed methods survey.

The COVID-19 pandemic has presented profound disruptions to young people at a critical period of psychosocial development. The current study aimed to explore the perceived negative and positive impacts of the COVID-19 pandemic on young people's mental health and wellbeing across a spectrum of clinical needs. A cross-sectional online survey including both quantitative and qualitative responses captured positive and negative impacts of COVID-19 across 593 young people with and without mental health care needs. Findings revealed high levels of clinical depression (48%), anxiety (51%), and loneliness in both samples. Approximately 75% of young people in primary mental health care services, and over 80% in the general population, reported a negative impact on work, non-work activities and mental health and wellbeing. Open-ended responses reflected positive impacts in the domains of greater capacity for self-care and reflection due to the decreased pressures of daily life. Negative impacts reflected worsening mental health, disruptions to key developmental milestones regarding relationships with self and others, and limited capacity for self-care. Together, these data highlight the critical need for early intervention support for the psychosocial impacts experienced by young people due to the pandemic, particularly among those with existing mental health care needs.

The effect of psychological treatment on repetitive negative thinking in youth depression and anxiety: a meta-analysis and meta-regression.

BACKGROUND: Depression and anxiety are prevalent in youth populations and typically emerge during adolescence. Repetitive negative thinking (RNT) is a putative transdiagnostic mechanism with consistent associations with depression and anxiety. Targeting transdiagnostic processes like RNT for youth depression and anxiety may offer more targeted, personalised and effective treatment. METHODS: A meta-analysis was conducted to examine the effect of psychological treatments on RNT, depression and anxiety symptoms in young people with depression or anxiety, and a meta-regression to examine relationships between outcomes. RESULTS: Twenty-eight randomised controlled trials examining 17 different psychological interventions were included. Effect sizes were small to moderate across all outcomes (Hedge's g depression = -0.47, CI -0.77 to -0.17; anxiety = -0.42, CI -0.65 to -0.20; RNT = -0.45, CI -0.67 to -0.23). RNT-focused and non-RNT focused approaches had comparable effects; however, those focusing on modifying the process of RNT had significantly larger effects on RNT than those focusing on modifying negative thought content. Meta-regression revealed a significant relationship between RNT and depression outcomes only across all intervention types and with both depression and anxiety for RNT focused interventions only. CONCLUSION: Consistent with findings in adults, this review provides evidence that reducing RNT with psychological treatment is associated with improvements in depression and anxiety in youth. Targeting RNT specifically may not lead to better outcomes compared to general approaches; however, focusing on modifying the process of RNT may be more effective than targeting content. Further research is needed to determine causal pathways.

Ownership, Use of, and Interest in Digital Mental Health Technologies Among Clinicians and Young People Across a Spectrum of Clinical Care Needs: Cross-sectional Survey.

BACKGROUND: There is currently an increased interest in and acceptance of technology-enabled mental health care. To adequately harness this opportunity, it is critical that the design and development of digital mental health technologies be informed by the needs and preferences of end users. Despite young people and clinicians being the predominant users of such technologies, few studies have examined their perspectives on different digital mental health technologies. OBJECTIVE: This study aims to understand the technologies that young people have access to and use in their everyday lives and what applications of these technologies they are interested in to support their mental health. The study also explores the technologies that youth mental health clinicians currently use within their practice and what applications of these technologies they are interested in to support their clients' mental health. METHODS: Youth mental health service users (aged 12-25 years) from both primary and specialist services, young people from the general population (aged 16-25 years), and youth mental health clinicians completed a web-based survey exploring technology ownership, use of, and interest levels in using different digital interventions to support their mental health or that of their clients. RESULTS: A total of 588 young people and 73 youth mental health clinicians completed the survey. Smartphone ownership or private access among young people within mental health services and the general population was universal (611/617, 99%), with high levels of access to computers and social media. Youth technology use was frequent, with 63.3% (387/611) using smartphones several times an hour. Clinicians reported using smartphones (61/76, 80%) and video chat (69/76, 91%) commonly in clinical practice and found them to be helpful. Approximately 50% (296/609) of the young people used mental health apps, which was significantly less than the clinicians (χ23=28.8, n=670; P<.001). Similarly, clinicians were significantly more interested in using technology for mental health support than young people (H3=55.90; P<.001), with 100% (73/73) of clinicians being at least slightly interested in technology to support mental health compared with 88% (520/591) of young people. Follow-up tests revealed no difference in interest between young people from the general population, primary mental health services, and specialist mental health services (all P>.23). Young people were most interested in web-based self-help, mobile self-help, and blended therapy. CONCLUSIONS: Technology access is pervasive among young people within and outside of youth mental health services; clinicians are already using technology to support clinical care, and there is widespread interest in digital mental health technologies among these groups of end users. These findings provide important insights into the perspectives of young people and clinicians regarding the value of digital mental health interventions in supporting youth mental health.

Digital technology for addressing cognitive impairment in recent-onset psychosis: A perspective.

Cognitive impairments in psychosis negatively impact functional recovery and quality of life. Existing interventions for improving cognitive impairment in recent-onset psychosis show inconsistent treatment efficacy, small effects, suboptimal engagement and limited generalizability to daily life functioning. In this perspective we explore how digital technology has the potential to address these limitations in order to improve cognitive and functional outcomes in recent-onset psychosis. Computer programs can be used for standardized, automated delivery of cognitive remediation training. Virtual reality provides the opportunity for learning and practicing cognitive skills in real-world scenarios within a virtual environment. Smartphone apps could be used for notification reminders for everyday tasks to compensate for cognitive difficulties. Internet-based technologies can offer psychoeducation and training materials for enhancing cognitive skills. Early findings indicate some forms of digital interventions for cognitive enhancement can be effective, with well-established evidence for human-supported computer-based cognitive remediation in recent-onset psychosis. Emerging evidence regarding virtual reality is favorable for improving social cognition. Overall, blending digital interventions with human support improves engagement and effectiveness. Despite the potential of digital interventions for enhancing cognition in recent-onset psychosis, few studies have been conducted to date. Implementation challenges affecting application of digital technologies for cognitive impairment in recent-onset psychosis are sustained engagement, clinical integration, and lack of quality in the commercial marketplace. Future opportunities lie in including motivational frameworks and behavioral change interventions, increasing service engagement in young people and lived experience involvement in digital intervention development.

The Mental Health and Social Media Use of Young Australians during the COVID-19 Pandemic.

Young people may be particularly vulnerable to the mental health impacts of the COVID-19 pandemic and may also be more likely to use social media at this time. This study aimed to explore young people's mental health and social media use during the COVID-19 pandemic and examined their use of social media to seek and provide support for suicidal thoughts and self-harm during this period. Young people aged 16-25 (n = 371, M = 21.1) from the general population in Australia completed an anonymous, cross-sectional online survey advertised on social media from June to October 2020. Participants reported high levels of psychological distress, with over 40% reporting severe levels of anxiety and depression, and those with a mental health diagnosis were more likely to perceive the pandemic to have had a negative impact on their mental health. Gender-diverse participants appeared the most negatively impacted. Social media use was high, with 96% reporting use at least once a day, and two-thirds reporting an increase in social media use since the start of the pandemic. One-third had used social media to seek support for suicidal thoughts or self-harm, and half had used it to support another person. This study adds to a growing literature suggesting social media can provide an opportunity to support young people experiencing psychological distress and suicide risk. Uniquely, this study points to the utility of using social media for this purpose during high-risk periods such as pandemics, where access to face-to-face support may be limited. To promote the quality and safety of support provided on social media, resources for help-seekers and help-givers should be developed and disseminated. Social media companies must consider the vulnerability of some users during pandemics and do what they can to promote wellbeing and safety.

The impact of persistent social anxiety on social functioning and health-related quality of life in young people with remitted first-episode psychosis.

OBJECTIVE: Comorbid social anxiety is common in psychotic disorders and is associated with multiple negative consequences. However, the long-term effects of persistent social anxiety versus fluctuating or no anxiety on social functioning and health-related quality of life (HR-QoL) have received scant attention. Therefore, we aimed to examine the prevalence of persistent social anxiety to determine its effect on social functioning and HR-QoL in first-episode psychosis (FEP). METHODS: One hundred and eight individuals with remitted FEP were classified into three groups (persistent, fluctuating or no social anxiety) according to the Social Interaction Anxiety Scale over an 18-month follow-up period. The three groups were then compared at 18 months follow-up to assess the influence of social anxiety on social functioning and HR-QoL before and after controlling for confounders. RESULTS: Of the 108 individuals with FEP, 25 (23.1%) had persistent social anxiety. This group presented lower social functioning and HR-QoL levels compared to the groups with fluctuating or no anxiety symptoms. The effect on HR-QoL remained significant after controlling for positive psychotic and depressive symptoms. CONCLUSIONS: In this study, nearly one-quarter of young people with remitted FEP experienced persistent social anxiety symptoms, which had a negative impact on HR-QoL. Thus, individuals with persistent social anxiety constitute a highly vulnerable group and may require targeted interventions to improve their social functioning and HR-QoL.

Psychometric properties of the Mindful Attention Awareness Scale (MAAS) in a first-episode psychosis sample.

Despite the considerable growth in mindfulness-based research in the field of psychosis, few attempts have been made to validate mindfulness instruments in this population. This study aimed to evaluate the factorial structure, internal consistency, construct validity, and longitudinal measurement invariance of the Mindful Attention Awareness Scale (MAAS) in a sample of individuals with first-episode psychosis (FEP). In a sample of 150 individuals with remitted FEP, the present study explored the factor structure, measurement invariance, reliability, convergent and discriminant validity of the MAAS. Confirmatory factor analysis supported a single-factor solution, which showed temporal stability, excellent internal consistency reliability (Cronbach's α = .92; McDonald's ω = .93), and theoretically coherent convergent and discriminant validity with measures of well-being, satisfaction with life, savoring, self-compassion, depression, anxiety, stress, and positive symptoms. Overall, the psychometric properties of the MAAS were similar to those described in previous validation studies, thus supporting the value of this instrument to assess the dimension of attention and awareness to the present moment in individuals with FEP. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

The growing field of digital psychiatry: current evidence and the future of apps, social media, chatbots, and virtual reality.

As the COVID-19 pandemic has largely increased the utilization of telehealth, mobile mental health technologies - such as smartphone apps, vir-tual reality, chatbots, and social media - have also gained attention. These digital health technologies offer the potential of accessible and scalable interventions that can augment traditional care. In this paper, we provide a comprehensive update on the overall field of digital psychiatry, covering three areas. First, we outline the relevance of recent technological advances to mental health research and care, by detailing how smartphones, social media, artificial intelligence and virtual reality present new opportunities for "digital phenotyping" and remote intervention. Second, we review the current evidence for the use of these new technological approaches across different mental health contexts, covering their emerging efficacy in self-management of psychological well-being and early intervention, along with more nascent research supporting their use in clinical management of long-term psychiatric conditions - including major depression; anxiety, bipolar and psychotic disorders; and eating and substance use disorders - as well as in child and adolescent mental health care. Third, we discuss the most pressing challenges and opportunities towards real-world implementation, using the Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework to explain how the innovations themselves, the recipients of these innovations, and the context surrounding innovations all must be considered to facilitate their adoption and use in mental health care systems. We conclude that the new technological capabilities of smartphones, artificial intelligence, social media and virtual reality are already changing mental health care in unforeseen and exciting ways, each accompanied by an early but promising evidence base. We point out that further efforts towards strengthening implementation are needed, and detail the key issues at the patient, provider and policy levels which must now be addressed for digital health technologies to truly improve mental health research and treatment in the future.

Perspectives of Trial Staff on the Barriers to Recruitment in a Digital Intervention for Psychosis and How to Work Around Them: Qualitative Study Within a Trial.

BACKGROUND: Recruitment processes for clinical trials of digital interventions for psychosis are seldom described in detail in the literature. Although trial staff have expertise in describing barriers to and facilitators of recruitment, a specific focus on understanding recruitment from the point of view of trial staff is rare, and because trial staff are responsible for meeting recruitment targets, a lack of research on their point of view is a key limitation. OBJECTIVE: The primary aim of this study was to understand recruitment from the point of view of trial staff and discover what they consider important. METHODS: We applied pluralistic ethnographic methods, including analysis of trial documents, observation, and focus groups, and explored the recruitment processes of the EMPOWER (Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-being, Engagement, and Recovery) feasibility trial, which is a digital app-based intervention for people diagnosed with schizophrenia. RESULTS: Recruitment barriers were categorized into 2 main themes: service characteristics (lack of time available for mental health staff to support recruitment, staff turnover, patient turnover [within Australia only], management styles of community mental health teams, and physical environment) and clinician expectations (filtering effects and resistance to research participation). Trial staff negotiated these barriers through strategies such as emotional labor (trial staff managing feelings and expressions to successfully recruit participants) and trying to build relationships with clinical staff working within community mental health teams. CONCLUSIONS: Researchers in clinical trials for digital psychosis interventions face numerous recruitment barriers and do their best to work flexibly and to negotiate these barriers and meet recruitment targets. The recruitment process appeared to be enhanced by trial staff supporting each other throughout the recruitment stage of the trial.

Implementation lessons from the transition to telehealth during COVID-19: a survey of clinicians and young people from youth mental health services.

Whilst telehealth may overcome some traditional barriers to care, successful implementation into service settings is scarce, particularly within youth mental health care. This study aimed to leverage the rapid implementation of telehealth due to COVID-19 to understand the perspectives of young people and clinicians on how telehealth impacts service delivery, service quality, and to develop pathways for future uses. Youth mental health service users (aged 12-25) and clinicians took part in an online survey exploring service provision, use, and quality following the adoption of telehealth. Service use data from the period were also examined. Ninety-two clinicians and 308 young people responded to the survey. Service use was reduced compared to the same period in 2019, however, attendance rates were higher. Across eight domains of service quality, the majority of young people reported that telehealth positively impacted service quality, and were significantly more likely to rate telehealth as having a positive impact on service quality than clinicians. There was high interest in continuing to use telehealth as part of care beyond the pandemic, supporting its permanent role in youth mental health care for a segment of service users. Future work should explore how best to support its long-term implementation.

Virtual reality as a clinical tool in mental health research and practice
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Virtual reality (VR) is a potentially powerful technology for enhancing assessment in mental health. At any time or place, individuals can be transported into immersive and interactive virtual worlds that are fully controlled by the researcher or clinician. This capability is central to recent interest in how VR might be harnessed in both treatment and assessment of mental health conditions. The current review provides a summary of the advantages of using VR for assessment in mental health, focusing on increasing ecological validity of highly controlled environments, enhancing personalization and engagement, and capturing real-time, automated data in real-world contexts. Considerations for the implementation of VR in research and clinical settings are discussed, including current issues with cost and access, developing evidence base, technical challenges, and ethical implications. The opportunities and challenges of VR are important to understand as researchers and clinicians look to harness this technology to improve mental health outcomes.
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La realidad virtual (RV) es una tecnología potencialmente poderosa para mejorar la evaluación en salud mental. En cualquier momento o lugar, las personas pueden ser transportadas y quedar inmersos en mundos virtuales interactivos que están totalmente controlados por el investigador o el clínico. Esta capacidad es parte fundamental del interés reciente por la manera en cómo se podría aprovechar la RV tanto en el tratamiento como en la evaluación de las condiciones de salud mental. Esta revisión proporciona un resumen de las ventajas del empleo de la RV para la evaluación en salud mental, enfocándose en el aumento de la validez ecológica de entornos altamente controlados, en mejorar la personalización y el compromiso, y capturar datos automatizados en tiempo real en contextos del mundo real. Se discuten las consideraciones para la implementación de la realidad virtual en investigación y en situaciones clínicas, incluidos los problemas actuales de costo y acceso, el desarrollo en base a la evidencia, los desafíos técnicos y las implicancias éticas. Es importante comprender las oportunidades y los desafíos de la realidad virtual, ya que los investigadores y los médicos buscan aprovechar esta tecnología para mejorar los resultados de salud mental.

L'évaluation de la santé mentale pourrait bénéficier de la puissance de la technologie de la réalité virtuelle (RV). Les sujets peuvent être transportés en immersion à tout moment ou en tout lieu dans des mondes virtuels interactifs totalement contrôlés par le chercheur ou le médecin. C'est ce qui motive l'intérêt récent sur la façon d'exploiter la RV à la fois dans le traitement et l'évaluation des maladies mentales. Notre présentation résume les avantages de la RV dans ce cadre ; elle est centrée sur la validité écologique renforcée des environnements très contrôlés, sur une meilleure personnalisation et participation du sujet, et sur la saisie de données automatisées en temps et contextes réels. Nous analysons les conditions de l'introduction de la RV en recherche et en clinique, y compris les enjeux actuels de coût et d'accès, le développement d'une base de données, les défis techniques et les questions éthiques. Chercheurs et médecins souhaitent expérimenter la réalité virtuelle pour améliorer les résultats dans le contexte de la santé mentale, il est donc important d'en comprendre les opportunités et les difficultés.

Blended Digital and Face-to-Face Care for First-Episode Psychosis Treatment in Young People: Qualitative Study.

BACKGROUND: A small number of studies have found that digital mental health interventions can be feasible and acceptable for young people experiencing first-episode psychosis; however, little research has examined how they might be blended with face-to-face approaches in order to enhance care. Blended treatment refers to the integration of digital and face-to-face mental health care. It has the potential to capitalize on the evidence-based features of both individual modalities, while also exceeding the sum of its parts. This integration could bridge the online-offline treatment divide and better reflect the interconnected, and often complementary, ways young people navigate their everyday digital and physical lives. OBJECTIVE: This study aimed to gain young people's perspectives on the design and implementation of a blended model of care in first-episode psychosis treatment. METHODS: This qualitative study was underpinned by an end-user development framework and was based on semistructured interviews with 10 participants aged 19 to 28 (mean 23.4, SD 2.62). A thematic analysis was used to analyze the data. RESULTS: Three superordinate themes emerged relating to young people's perspectives on the design and implementation of a blended model of care in first-episode psychosis treatment: (1) blended features, (2) cautions, and (3) therapeutic alliance. CONCLUSIONS: We found that young people were very enthusiastic about the prospect of blended models of mental health care, in so far as it was used to enhance their experience of traditional face-to-face treatment but not to replace it overall. Aspects of blended treatment that could enhance clinical care were readily identified by young people as increasing accessibility, continuity, and consolidation; accessing posttherapy support; strengthening the relationship between young person and clinician; and tracking personal data that could be used to better inform clinical decision making. Future research is needed to investigate the efficacy of blended models of care by evaluating its impact on the therapeutic alliance, clinical and social outcomes, cost-effectiveness, and engagement.

Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-Being, Engagement, and Recovery: Protocol for a Feasibility Cluster Randomized Controlled Trial Harnessing Mobile Phone Technology Blended With Peer Support.

BACKGROUND: Relapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. OBJECTIVE: This study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. METHODS: We will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants' own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. RESULTS: Recruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. CONCLUSIONS: The knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, sample size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15058.

Client experiences of blending a coping-focused therapy for auditory verbal hallucinations with smartphone-based ecological momentary assessment and intervention.

This study explored participants' experiences of a novel intervention blending ecological momentary assessment and intervention (EMA/I) digital technologies with four face-to-face therapy sessions to improve coping in people who experience persisting auditory verbal hallucinations (hear voices). A smartphone app was used to deliver prompts to facilitate both self-monitoring and self-management of voices. Analysis of data recorded by the app was also used in-session to develop an idiographic formulation of antecedents of and responses to voice-hearing episodes. Semi-structured interviews were conducted with 12 participants who completed the blended therapy. A thematic approach was used to analyse the data, generating four main themes, with associated subthemes: (1) Therapy experience changed by digital technology; (2) Valuing face-to-face component; (3) Preference for different phases of the digital technology; (4) Not as bothered by voices. Key findings revealed that participants perceived EMA/I technology as helping capture their experience more accurately and communicate this more effectively to the therapist, which, in combination with coping prompts developed in-session, deepened the therapeutic relationship. These findings add to the emerging literature that shows blended therapy can play an important role in the treatment of people with psychosis, and suggest potential of EMA/I as a technology for other clinical populations.

Pilot randomised controlled trial of a brief coping-focused intervention for hearing voices blended with smartphone-based ecological momentary assessment and intervention (SAVVy): Feasibility, acceptability and preliminary clinical outcomes.

BACKGROUND: Voice-hearing experiences can be distressing and impairing, and existing psychological treatments show modest effectiveness. Ecological momentary assessment and intervention (EMA/I) are two promising approaches which may be used as digital tools to support and enhance existing psychological therapies. The aim of this study was to investigate the potential clinical utility of smartphone-based EMA/I in a blended, coping focused therapy for voice-hearing experiences. METHOD: This pilot RCT focused on feasibility, acceptability and preliminary estimations of efficacy. Thirty-four participants with persisting and distressing voices were randomised to receive the four-session intervention along-side treatment-as-usual (TAU) or TAU-only. RESULTS: Findings supported the feasibility and acceptability of the approach, with good engagement and satisfaction rates, and clinical outcomes showed the intervention holds promise for improving coping, overall severity of voices and to some degree their negative impact. CONCLUSION: This is the first examination of the use of EMA/I in a blended therapy for psychotic experiences, with findings suggesting these technologies show promise as clinical tools.