IMMERSE moves beyond the state-of-the-art by providing a highly-needed innovation in the field of mental health care. This includes:
• Covered mental disorders: The DMMH is applicable for a variety of mental health care disorders and in a variety of mental health care settings, with the clinical sites included in our randomised controlled trial covering different disorders and including both in and out-patient settings.
• Effectiveness and usability: There is a lack of rigorous testing of effectiveness and usability. Phase 1 of IMMERSE is providing detailed information on the social and behavioural aspects related to the intended use of IMMERSE in routine mental health care, providing information on appropriation of digital self-monitoring tools, usage barriers for service users and clinicians, data visualisations and privacy issues. In Phase 2 of IMMERSE, we are testing effectiveness and feasibility, while closely evaluating the implementation process in 4 countries in Europe.
• Interventions: IMMERSE introduces a new model of behavioural change which deviates from traditional therapeutic approaches. Using the MoMent app and dashboard, both clinicians and service users get feedback on personalised patterns of associations, thus providing a granular understanding of real-life processes, including their mental health problems and the context thereof. In addition, we are investigating specific psychological processes that are targeted by the DMMH (e.g. mentalisation and dynamic avoidance).
• Technology: In the IMMERSE project, we are integrating passive sensor information with the self-report data and we have developed and validated deep time series models integrating multi-modal data. Furthermore, we have developed a hierarchisation framework, allowing integration across data from different users. These models move beyond state-of-the-art ML approaches as they allow the integration over individual time series and make use of group-level information for single patient predictions.
• Medical technology transfer and scale-up: IMMERSE has gone beyond the state-of-the-art by developing the building blocks of the platform under a quality management system and based on sustainable components and the scalable technology platform TherapyBuilder. We have approval from the Component Authorities. Also, FHIR specifications for interoperability with the international research community as well as integration capability with hospital systems has been provided, to work on the transfer from a research app to a medical device. Furthermore, we have outlined the problems in the regulatory framework on medical devices, which may hamper the further scale-up of digital innovations in Europe.
• Implementation and scalability: IMMERSE will simultaneously test the treatment effects and implementation models. Our implementation study using an optimum cRCT design over 8 sites in 4 different countries all in different stages of take-up of mHealth, allows investigating implementation processes and outcomes as well as cost-effectiveness. We have developed a research agenda for the implementation of innovative digital devices in mental health care. Furthermore, we have done a market analysis and are creating a business plan for the further deployment of DMMH.
