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.

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.

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.

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
.

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.
.

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.

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.

Potential Applications of Digital Technology in Assessment, Treatment, and Self-help for Hallucinations.

The field of digital mental health is rapidly expanding with digital tools being used in assessment, intervention, and supporting self-help. The application of digital mental health to hallucinations is, however, at a very early stage. This report from a working group of the International Consortium on Hallucinations Research considers particular synergies between the phenomenon of hallucinations and digital tools that are being developed. Highlighted uses include monitoring and managing intermittently occurring hallucinations in daily life; therapeutic applications of audio and video media including virtual and augmented reality; targeting verbal aspects of hallucinations; and using avatars to represent hallucinatory voices. Although there is a well-established Internet-based peer support network, digital resources for hallucinations have yet to be implemented in routine practice. Implementation may benefit from identifying how to market resources to the broad range of populations who experience hallucinations and identifying sustainable funding models. It is envisaged that digital tools will contribute to improved self-management and service provision for people experiencing hallucinations.

Smartphone-based ecological momentary assessment and intervention in a blended coping-focused therapy for distressing voices: Development and case illustration.

Common approaches to the psychological treatment of distressing voice hearing experiences, such as cognitive behavioural therapy, aim to promote more adaptive cognitive, emotional and behavioural responses to these experiences. Digital technologies such as smartphones show promise for supporting and enhancing these treatments by linking immediate therapeutic settings to the context of daily life. Two promising technologies include ecological momentary assessment and intervention (EMA/I), which may offer a means of advanced assessment and support in daily life, and inform the tailoring of interventions to suit individual needs. In this study, a highly novel intervention approach was developed involving four face-to-face sessions with a psychologist blended with EMA/I between sessions in order to improve coping with distressing voice hearing experiences. The authors describe the background and development of this approach along-side a single case illustration, which supported feasibility and acceptability. This study details how digital technologies such as EMA/I may be used in future as clinical tools to enhance standard psychological treatments and clinical care of people with persisting and distressing experiences.

A systematic review of task-based functional neuroimaging studies investigating language, semantic and executive processes in thought disorder.

The aim of the current systematic review was to synthesise the research that has investigated thought disorder (TD) using task-based functional neuroimaging techniques to target executive, language, or semantic functions. Thirty-five pertinent studies were identified from January 1990 to August 2016. Functional correlates of TD included the superior and middle temporal, fusiform, and inferior frontal gyri bilaterally, as well as the left and right cingulate cortex, the right caudate nucleus, and the cerebellum. TD-related increases and decreases in activation were both evident in most of these regions. However, the specificity of these correlates from general clinical and cognitive influences is unknown. The cortical regions implicated overlap with those thought to contribute to language and semantic systems. Cortico-striatal circuitry may also play a role in some aspects of TD through aberrant salience representation and inappropriate attentional prioritisation. To advance the field further, greater integration across structural, functional, and behavioural measures is required, in addition to non-unitary considerations of TD.

Smartphone-based ecological momentary assessment and intervention in a coping-focused intervention for hearing voices (SAVVy): study protocol for a pilot randomised controlled trial.

BACKGROUND: Smartphone-based ecological momentary assessment and intervention (EMA/I) show promise for enhancing psychological treatments for psychosis. EMA has the potential to improve assessment and formulation of experiences which fluctuate day-to-day, and EMI may be used to prompt use of therapeutic strategies in daily life. The current study is an examination of these capabilities in the context of a brief, coping-focused intervention for distressing voice hearing experiences. METHODS/DESIGN: This is a rater-blinded, pilot randomised controlled trial comparing a four-session intervention in conjunction with use of smartphone EMA/I between sessions, versus treatment-as-usual. The recruitment target is 34 participants with persisting and distressing voice hearing experiences, recruited through a Voices Clinic based in Melbourne, Australia, and via wider advertising. Allocation will be made using minimisation procedure, balancing of the frequency of voices between groups. Assessments are completed at baseline and 8 weeks post-baseline. The primary outcomes of this trial will focus on feasibility and acceptability of the intervention and trial methodology, with secondary outcomes examining preliminary clinical effects related to overall voice severity, the emotional and functional impact of the voices, and emotional distress. DISCUSSION: This study offers a highly novel examination of specific smartphone capabilities and their integration with traditional psychological treatment for distressing voices. Such technology has potential to enhance psychological interventions and promote adaptation to distressing experiences. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry, ACTRN12617000348358 . Registered on 7 March 2017.

A systematic review of the structural neuroimaging correlates of thought disorder.

One clinical dimension often cited as a hallmark of schizophrenia is thought disorder (TD). The aim of the current systematic review was to summarise our current understanding of the neurobiology of TD that has been investigated with structural neuroimaging techniques. Ninety-seven relevant studies were identified from January 1990 to August 2016, 26 of which had TD-motivated research questions or hypotheses. The remaining 71 studies conducted exploratory clinical analyses that included TD amongst a number of psychotic symptoms. These studies implicate the left superior temporal gyrus in TD. There was also evidence to suggest associations between TD and structural measures within the orbitofrontal cortex, cerebellum, nucleus accumbens, and amygdala-hippocampal region. However, there is a dearth of structural neuroimaging research driven by TD-motivated hypotheses. Furthermore, few studies have explored specific TD symptoms or subgroups, or surface-based morphometric measures of cortical structure, despite theoretical and practical reasons for doing so. It is hoped that the current review will assist in the augmentation of diverse hypothesis-driven research into the aetiology of TD.

Ecological Momentary Assessment and Intervention in the Treatment of Psychotic Disorders: A Systematic Review.

OBJECTIVE: Ecological momentary assessment (EMA) and ecological momentary intervention (EMI) are technologies used to track fluctuations in experiences and prompt behavioral responses within the context of a person's daily life. Most commonly delivered via smartphone, EMA and EMI have potential to provide simple, cost-effective, and user-led treatment for psychotic disorders. This systematic review aimed to synthesize current research exploring the feasibility, acceptability, and clinical outcomes of EMA and EMI in the treatment of psychotic disorders. METHODS: A systematic search was conducted identifying studies published between 1980 and July 7, 2016, by searching PubMed, PsycINFO, PsycARTICLES, and the Cochrane Central Register of Controlled Trials with combinations of search terms related to mobile devices, EMA and EMI, and psychotic disorders. RESULTS: Of 1,623 studies identified, nine met inclusion criteria for the review. These studies found satisfactory feasibility and acceptability and preliminary evidence of improved clinical outcomes. The interventions, which had a broad array of features, targeted remote monitoring of illness and symptoms, and they also targeted illness self-management by using momentary reminders or instructions for behaviors, including medication adherence, management of symptoms and psychosocial impairments, daily living skills, and goal achievement. CONCLUSIONS: The findings of this review provide preliminary support for the clinical utility of EMA and EMI in the treatment of psychotic disorders. Future research should explore further applications of these technologies with larger sample sizes and controlled designs.