Digital mental health interventions (DMHIs) may reduce the symptoms and impairments of mental health conditions. Furthermore, they may aid clinical and cost-effectiveness, providing that safety and acceptability are addressed. We outline why depressed and anxious adolescents need such a tool, and the principles for building and testing a DMHI.
The impact of sitting on a waiting list
Increasing waiting lists for specialist children and young people’s mental health services (CYPMHS) are a major barrier to mental healthcare. From 2019 to 2023, CYPMHS received almost 1 million referrals, of which more than a third (36%) were rejected unseen. Another third (32%) were assessed within an average of 9 weeks while a further 32% waited beyond 28 weeks, with 6% waiting for 1 year or more. Waiting for more than 8 weeks may prolong mental illness, moderate time to remission and decrease service satisfaction. 1 Surprisingly, 30% of children and young people assessed by CYPMHS receive only one or two sessions before discharge. The required human resource is neither available nor affordable to address the increased numbers of referrals, which may rise further given the higher prevalence of anxiety and depression among teenagers shown in official government statistics. Harnessing technology to deliver a DMHI to adolescents on CYPMHS waiting lists seems worth exploring. Might a brief DMHI while waiting reduce symptoms and distress and preserve function? This is a testable hypothesis, providing there is a valid DMHI for moderate to severely depressed and anxious young people. Such a DMHI might also support subsequent engagement in therapy.
The digital mental health landscape
There are an estimated 10 000 mental health apps across the life course, but the precise numbers focused on adolescents are not known. There are good examples of products, mostly for mild to moderate anxiety and depression (e.g. SilverCloud, LumiNova, Sleepio). The DMHI MOST is well researched and implemented as a transdiagnostic DMHI for youth with moderate to severe disorders, and is now integrated into routine services. Reference Cross, Mangelsdorf, Valentine, O’Sullivan, McEnery and Scott2 The ‘app landscape’ is, however, largely unregulated and National Health Service (NHS) Trusts cannot be certain of the evidence for these products’ real-world effectiveness, nor their safety and acceptability. Reference Hopkin, Branson, Campbell, Coole, Cooper and Edelmann3 Furthermore, the purpose of apps is variable, with some designed to prevent mental health difficulties, some focused on supporting users through mild distress and others aimed at the severely mentally ill. NHS managers need to determine whether the app suggested to them is in fact designed for their patients and is safe, as well as clinically and cost-effective. NHS Trusts may need to set up a co-professional DMHI oversight and governance group to consider evidence of effects, safety and user acceptability.
The method of intervention delivery also needs consideration: apps may be self-administered, and content can be viewed and reviewed as the user wishes; some are menu-driven and used in order according to the programme, while others are goal-directed and/or gamified. Finally, there are guided therapies blended with an available live practitioner. The National Institute for Health and Care Excellence (NICE) currently has no full recommendations for digital intervention in clinical episodes of mild, moderate or severe depression in adolescents, meaning that CYPMHS lack guidance on the selection and deployment of DMHIs within their CYPMHS.
Prospects for anxious and depressed adolescents attending NHS clinics
There is now sufficient evidence to support the clinical efficacy of a range of designs and digitised methods for youth with mild, moderate and severe depression and anxious disorders. Reference Cross, Mangelsdorf, Valentine, O’Sullivan, McEnery and Scott2 However, we still lack understanding about clinical effectiveness, acceptability, safety and what activates implementation in real-world settings. Reference Hopkin, Branson, Campbell, Coole, Cooper and Edelmann3 For example, one small randomised controlled trial (RCT) of an online digital intervention for adolescents with mild to moderate social anxiety disorders in the community has provisional NICE approval for adolescents. Reference Leigh and Clark4 There is also a DMHI for moderate to severe depressed adolescents in the early stages of testing. Reference Jones, Thapar, Rice, Mars, Agha and Smith5 However, a suitably powered pragmatic effectiveness RCT has yet to be reported for either of these DMHIs. Interestingly, a single-session, pragmatic, real-world design study of an online intervention for mildly anxious and/or depressed adolescents has demonstrated that psychoeducation or behavioural activation are equally clinically effective, and superior to a digital storytelling control condition. Reference Schleider, Mullarkey, Fox, Dobias, Shroff and Hart6
Building a DMHI
Co-production among digital designers, practitioners, experts by experience and key stakeholders/organisations is essential. This ensures that the nature of mental illness and its impairments is considered and that DMHIs are evaluated in real-world conditions to optimise acceptability and implementation.
Content
Most DMHIs report that their content is based on cognitive–behavioural therapy principles, yet few describe these in sufficient detail. Developers should also describe what media methods and styles were used (text, images, audio, video, cartoon, TikTok, etc.) to deliver content and why they were chosen. Current evidence suggests that a DMHI based on (a) psychoeducation, (b) problem-solving techniques for specific difficulties such as sleep or emotional dysregulation and (c) activities and skills building to reduce social isolation and feelings of loneliness is most successful in encouraging engagement and retention among depressed adolescents. Reference Jones, Thapar, Rice, Mars, Agha and Smith5,Reference Schleider, Mullarkey, Fox, Dobias, Shroff and Hart6
Process
The digital production process needs to include extensive quality assurance to ensure correct content, design and build for successful implementation. Quality assurance is a systematic process that focuses on preventing defects, ensuring safety and supporting product versions and services. It aims to align the DMHI to regulatory standards and user expectations. NICE has produced an evidence standards framework to support DMHI development. 7
Co-production processes are best achieved through recruiting focus groups of key stakeholders from the outset, who meet regularly with research team members. Their advice and recommendations regarding product development, deployment and use should be adopted wherever possible. Engagement with youth advisory boards and parent stakeholder groups, and also service providers to contribute to the design and implementation of pragmatic trials, also essential.
Following quality assurance, a DMHI must undergo user acceptability testing (UAT), where the software is evaluated by its intended end-user population. This ensures that the software is ready for deployment by addressing usability issues, functionality gaps or other problems that might have been missed during quality assurance. Together, quality assurance and UAT are referred to as the ‘alpha phase’ of product development, which aims to (a) gain a full understanding of translating a best-evidence, face-to-face intervention into a digital environment; (b) improve the production team’s understanding of the end-users’ needs and expectations of a DMHI; and (c) help implementation by understanding tensions that may become barriers of how end-users and organisations align and achieve their goals (e.g. improve mental health and reduce waiting lists). The alpha phase also contributes to cost reduction by addressing product software and digital interface issues early to avoid later costly reworking.
In the subsequent ‘beta phase’ of development, the DMHI prototype is released to a limited group of real users to identify bugs, usability issues and areas for improvement. Beta testing aims to identify and address issues with the DMHI in a real-world clinical setting that might not be apparent during alpha testing. Crucially, this beta phase of DMHI production must also be code-signed with individuals with lived experience of mental health difficulties and their support networks, together with the professionals and organisations who deliver care.
The ‘live testing’ phase follows the beta phase, including RCTs of sufficient sample size and longitudinal outcome studies of end-users. These give practitioners, NHS Trusts, NICE, the Medicines and Health Regulatory Authority (MHRA) and policy-makers the information required to deliver and, where appropriate for software as medical devices, regulate these evidence-based treatments. These data include patient, carer and staff experiences, clinical and cost effectiveness, safety, benefits and risks.
The new NHS 10 Year Health Plan for England is part premised on a new emerging digitally enabled age. Unfortunately, a recent RCT evaluating routine clinical practice in CYPMHS reported low or poor use of face-to-face therapies based on best evidence, with poor outcomes a year later. Reference Sayal, Wyatt, Partlett, Ewart, Bhardwaj and Dubicka8 Healthcare organisations need guidance and support to ensure that therapeutic development is evidence-based, that patient progress is evaluated and that a treatment-learning environment is created for practitioners. Establishing these organisational conditions would help bring to life a ‘digital first’ aspiration and integrate DMHIs to advance treatment success.
Finally, DMHIs need to be trusted and trustworthy. The MHRA classifies a minority of DMHIs as ‘software as a medical device’, and provides associated international standards and regulation for them. The MHRA currently differentiates on the basis of having a core medical purpose, being of sufficient complexity as an interface, and the degree of vulnerability and risks associated with the intended target population. MHRA evaluation is non-trivial but helps to assure the quality, safety and standards of those DMHIs that meet its criteria. DMHI developers should be alert to these complexities early in production, and also NHS providers in their subsequent deployment. Such devices will have a UK Conformity Assessed mark with or without a European Union Conformité Européenne mark.
With due care and attention, DMHIs do have promise to be clinically innovative, effective and efficient, and can indeed help the NHS and others achieve the worthy aspirations set out in the 10-year plan for health in the UK.
Author contributions
T.F. (principal investigator), R.K., I.G., A.-M.B., R.N., P.A. and J.G. (co-applicants) and C.C. (employed researcher) collaborated on the NIHR Wait Less study, from which this Guest Editorial arose. All authors contributed substantially to the conceptualisation of the editorial, and contributed to shaping and revising the manuscript. I.G. led the drafting for both the initial submission and revision.
Funding
This Guest Editorial arose from our experience on the Wait Less study (no. NIHR 158583), which is funded by the NIHR Health and Social Care Delivery Research Programme. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
Declaration of interest
I.G. and R.K. co-direct CambridgeBPI Ltd, which developed Brief Psychosocial Intervention and its digital corollary. R.K. is employed, part-time, by NHS England as National Clinical Educator Lead for MindEd; nothing in this article should be understood as R.K. representing the views or opinions of NHS England, nor the Department of Health and Social Care, England. T.F.’s research group receives funding for research methods consultation from Place2Be, a third-sector organisation providing mental health training and intervention to schools. T.F. is an editorial adviser to BJPsych’s editorial board, and did not take part in the review or decision-making process of this paper. The other authors have no interests to declare.
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