Digital Mental Health in the Wild: An Adapted Grounded Theory Study

This study explores Digital Mental Health (DMH), referring to the use of digital technologies in mental health, from the perspective of users and system builders – individuals ‘in the wild’. Using an adapted constructive Grounded Theory Methodology (Charmaz, 2014), it qualitatively explores DMH and how it is applied to everyday life. Interviews with users, developers and academics were supported by data collected from extant documents and observations. Findings addressed the complexity of development and use, where differences in priority between the technical and clinical paradigms in development challenged the usability and usefulness for consumers of DMH. Changes implemented within, and the transience of, DMH resources were constructed by users as potentially distressing and difficult for system builders to mitigate. DMH is a new and emerging way to self-manage mental health. However, whilst it provides options, it does not inform as to how to choose and, whilst it supports change, it is not in itself motivating. In understanding the role of DMH it is essential to consider it alongside existing mental health prevention and management. DMH is constructed not as use of a single resource, but rather a toolkit for self-management where resources are used in different ways and at different times. Some will be integral whilst others may be used more occasionally. Many of the participants identified the difficulties and challenges of managing their mental health with only traditional tools and interventions available, and how DMH offered additional ways of doing so. DMH offers users autonomy and a way to explore their experiences in a simulated environment, contributing to its purpose as a supplement to existing mental health provision. Understanding how DMH can supplement the existing treatment and management of mental health is essential. One key area is addressing the opportunities provided by the simulative functions of new technologies and how mobile technologies have enabled these to become part of the everyday lives of so many people. Finally, the concept of Technology-asAdvocate was constructed to identify the ways that technology can help individuals to help themselves. This study recommends that DMH stakeholders invest and conduct further research that bring together clinical, technical and user paradigms to better understand how changes to devices and resources impact users. It positions DMH within the initial stages of help-seeking and addresses its role as one of many tools in the individual’s self-care. It proposes that technology be viewed as supporting self-advocacy and theorises that future technologies, such as personal assistants, be designed to advocate rather than to dictate. It is vital that policymakers recognise the impact of changes for users who find resources that support them in their mental health and apply them within their everyday life

Commentary: Let’s get digital: a commentary on Halldorsson et al.'s call for more rigorous development and evaluation of immersive digital interventions for children and young people's mental health

In the JCPP Annual Research Review for 2021, Halldorsson and colleagues (2021) present a systematic review of applied games and virtual reality interventions for treating mental health problems in children and young people, looking at the effectiveness of interventions upon mental health outcomes but also on the experience of using such interventions. In this commentary, we highlight a number of considerations in understanding what research has been achieved so far, and ideas for what needs to be looked at next in further advancing this field

Virtual, augmented, mixed, and extended reality interventions in healthcare: a systematic review of health economic evaluations and cost-effectiveness

IntroductionHealth economic evaluations are required to best understand the value of interventions to the health economy. As extended reality technologies (an umbrella term including virtual, augmented, and mixed reality) become cheaper and more accessible it is likely that they will be used more within healthcare.ObjectiveThe aim of this study was to systematically review common practices within health economic evaluations of extended reality interventions in healthcare and to discuss the methods, outcomes, and methodological quality to inform future HEEs.MethodsMEDLINE, Embase, NHSEED, PubMed, and the ACM Digital Library were searched, and studies retrieved and screened. We extracted descriptions of the population, intervention, comparator, outcomes, context, costs, and economic evaluation data from studies that fit our criteria. We included studies that involved healthcare patients who were provided extended reality interventions versus standard care, other types of care, or another extended reality application within the same setting where the outcome included both health outcomes and health economic evaluations.ResultsThe search identified 1,693 records in total, of which 1,271 were excluded after title and abstract screening. A total of 422 articles were retrieved and screened and the majority (n = 233) were excluded as they did not contain a health economic analysis or cost data. Fourteen articles were included in this review, all of which found that extended reality health interventions could provide cost savings. Our findings showed considerable heterogeneity between studies and a lack of clear descriptions of XR interventions, limiting their use within procurement.ConclusionExtended reality in healthcare has the potential to offer significant clinical benefits and research has shown it to be promising at delivering cost-savings. We make recommendations based on the findings of our review for future health economic analyses to help ensure that health economic analyses can support decision-makers in procuring these technologies.Trial registrationPROSPERO 2022 CRD42022342110

Research into digital health intervention for mental health: a 25-year retrospective on the ethical and legal challenges

Digital mental health interventions are routinely integrated into mental health services internationally, and can contribute to the reduction of the global mental health treatment gap that has been identified by the World Health Organisation. Research teams designing and delivering evaluations frequently invest substantial effort in deliberating on ethical and legal challenges around digital mental health interventions. In this article, we reflect on our own research experience of digital mental health intervention design and evaluation to identify eight of the most critical challenges that we or others have faced, and that have ethical or legal consequences. These are: 1) Harm caused by online recruitment work; 2) Monitoring of intervention safety; 3) Exclusion of specific demographic or clinical groups; 4) Inadequate robustness of effectiveness and cost-effectiveness findings; 5) Adequately conceptualising and supporting engagement and adherence; 6) Structural barriers to implementation; 7) Data protection and intellectual property; and 8) Regulatory ambiguity relating to digital mental health interventions that are medical devices. As we describe these challenges, we have highlighted serious consequences that can or have occurred, such as substantial delays to studies if regulations around Software as a Medical Device are not fully understood, or if regulations change substantially during the study lifecycle. Collectively, the challenges that we have identified highlight a substantial body of knowledge and expertise that is required, either within the team, or through access to external experts. Ensuring access to expertise requires careful planning, and adequate financial resources, for example to pay public contributors to engage debate on critical ethical issues, or to pay for legal opinions on regulatory issues. Access to such resources can be planned for on a per-study basis, and enabled through funding proposals. However, organisations regularly engaged in the development and evaluation of digital mental health interventions should consider creating or supporting structures such as advisory groups who can retain necessary competences, such as in medical devices regulation

Accessing online data for youth mental health research: meeting the ethical challenges

This article addresses the general ethical issues of accessing online personal data for research purposes. The authors discuss the practical aspects of online research with a specific case study that illustrates the ethical challenges encountered when accessing data from Kooth, an online youth web-counselling service. This paper firstly highlights the relevance of a process-based approach to ethics (Markham and Buchanan, 2012) when accessing highly sensitive data and then discusses the ethical considerations and potential challenges regarding the accessing of public data from Digital Mental Health (DMH) services. It presents solutions that aim to protect young DMH service users as well as the DMH providers and researchers mining such data. Special consideration is given to service users’ expectations of what their data might be used for, as well as their perceptions of whether the data they post is public, private or open. We provide recommendations for planning and designing online research in an ethical manner that includes vulnerable young people as research participants. We emphasise the distinction between public, private and open data, which is crucial to comprehend the ethical challenges in accessing DMH data. Among our key recommendations, we foreground the need to consider a collaborative approach with the DMH providers while respecting service users’ control over personal data, and we propose the implementation of digital solutions embedded within the platform for explicit opt-out/opt-in recruitment strategies and ‘read more’ options (Bergin and Harding, 2016)

Automated virtual reality cognitive therapy for people with psychosis: Protocol for a qualitative investigation using peer research methods

BACKGROUND: Many people with psychosis experience difficulties in everyday social situations. Anxiety can make life challenging, leading to withdrawal. Cognitive therapy, using active in vivo learning, enables people to overcome fears. These treatments are not readily available to people with psychosis. Automated virtual reality (VR) therapy is a potential route to increase accessibility. The gameChange automated VR cognitive therapy is designed to help people overcome anxious avoidance and build confidence in everyday social situations. A virtual coach guides the person through the treatment. Understanding user experience is key to facilitating future implementation. Peer research methods, in which people with lived experience of the issues being studied are involved in collecting and analyzing data, may be useful in developing this understanding. This encourages researchers to draw on their lived experience to explore participant perspectives and co-create knowledge. OBJECTIVE: The primary objective is to use a peer research approach to explore the participant experience of a novel automated VR therapy for anxious social avoidance. This includes understanding (1) the experience of anxious social avoidance in people with psychosis, (2) the experience of the gameChange automated VR cognitive therapy, and (3) any potential impact of the therapy in people’s lives. This will inform future implementation strategies. The secondary objective is to explore how peer research can be used to co-create knowledge. METHODS: Semistructured interviews will be conducted with approximately 25 people with psychosis participating in the gameChange trial (ISRCTN17308399). Participants will be recruited from the five trial centers based in National Health Service mental health trusts across England. Interviews will be conducted by two researchers. One is a peer researcher with similar lived experience to the trial participants. The other has lived experiences of mental health issues that do not directly overlap with those of the trial participants. Interview questions will focus on an individual’s experience of anxious social avoidance, experiences of participating in the gameChange VR therapy, and any changes or impact following therapy. The interview schedule was developed in collaboration with the gameChange Lived Experience Advisory Panel (LEAP), comprising 10 project advisors with lived experience of psychosis. Interpretative phenomenological analysis and template analysis will be used to explore individual accounts. The LEAP will contribute to the analysis. RESULTS: Data collection will be conducted from April to September 2021, and analysis will be conducted from June to October 2021. As of September 28, 2021, 20 participants had been interviewed, and coding is underway. CONCLUSIONS: The study, employing a peer research approach, may provide a unique insight into the experiences of anxious social avoidance in people with psychosis and its treatment using automated VR therapy. This will inform potential future implementation of VR automated therapies in mental health services

Developing a process for assessing the safety of a digital mental health intervention and gaining regulatory approval: a case study and academic's guide.

The field of digital mental health has followed an exponential growth trajectory in recent years. While the evidence base has increased significantly, its adoption within health and care services has been slowed by several challenges, including a lack of knowledge from researchers regarding how to navigate the pathway for mandatory regulatory approval. This paper details the steps that a team must take to achieve the required approvals to carry out a research study using a novel digital mental health intervention. We used a randomised controlled trial of a digital mental health intervention called STOP (Successful Treatment of Paranoia) as a worked example. The methods section explains the two main objectives that are required to achieve regulatory approval (MHRA Notification of No Objection) and the detailed steps involved within each, as carried out for the STOP trial. First, the existing safety of digital mental health interventions must be demonstrated. This can refer to literature reviews, any feasibility/pilot safety data, and requires a risk management plan. Second, a detailed plan to further evaluate the safety of the digital mental health intervention is needed. As part of this we describe the STOP study's development of a framework for categorising adverse events and based on this framework, a tool to collect adverse event data. We present literature review results, safety-related feasibility study findings and the full risk management plan for STOP, which addressed 26 possible hazards, and included the 6-point scales developed to quantify the probability and severity of typical risks involved when a psychiatric population receives a digital intervention without the direct support of a therapist. We also present an Adverse Event Category Framework for Digital Therapeutic Devices and the Adverse Events Checklist-which assesses 15 different categories of adverse events-that was constructed from this and used in the STOP trial. The example shared in this paper serves as a guide for academics and professionals working in the field of digital mental health. It provides insights into the safety assessment requirements of regulatory bodies when a clinical investigation of a digital mental health intervention is proposed. Methods, scales and tools that could easily be adapted for use in other similar research are presented, with the expectation that these will assist other researchers in the field seeking regulatory approval for digital mental health products. [Abstract copyright: © 2024. The Author(s).

Estimating the Economic Value of Automated Virtual Reality Cognitive Therapy for Treating Agoraphobic Avoidance in Patients With Psychosis: Findings From the gameChange Randomized Controlled Clinical Trial

Background:An automated virtual reality cognitive therapy (gameChange) has demonstrated its effectiveness to treat agoraphobia in patients with psychosis, especially for high or severe anxious avoidance. Its economic value to the health care system is not yet established.Objective:In this study, we aimed to estimate the potential economic value of gameChange for the UK National Health Service (NHS) and establish the maximum cost-effective price per patient.Methods:Using data from a randomized controlled trial with 346 patients with psychosis (ISRCTN17308399), we estimated differences in health-related quality of life, health and social care costs, and wider societal costs for patients receiving virtual reality therapy in addition to treatment as usual compared with treatment as usual alone. The maximum cost-effective prices of gameChange were calculated based on UK cost-effectiveness thresholds. The sensitivity of the results to analytical assumptions was tested.Results:Patients allocated to gameChange reported higher quality-adjusted life years (0.008 QALYs, 95% CI –0.010 to 0.026) and lower NHS and social care costs (–£105, 95% CI –£1135 to £924) compared with treatment as usual (£1=US $1.28); however, these differences were not statistically significant. gameChange was estimated to be worth up to £341 per patient from an NHS and social care (NHS and personal social services) perspective or £1967 per patient from a wider societal perspective. In patients with high or severe anxious avoidance, maximum cost-effective prices rose to £877 and £3073 per patient from an NHS and personal social services perspective and societal perspective, respectively.Conclusions:gameChange is a promising, cost-effective intervention for the UK NHS and is particularly valuable for patients with high or severe anxious avoidance. This presents an opportunity to expand cost-effective psychological treatment coverage for a population with significant health needs.Trial Registration:ISRCTN Registry ISRCTN17308399; https://www.isrctn.com/ISRCTN1730839