Periodic Reporting for period 2 - IMMERSE (The implementation of Digital Mobile Mental Health in clinical care pathways: Towards person-centered care in psychiatry)
Okres sprawozdawczy: 2022-10-01 do 2024-03-31
Mental health problems constitute a major individual, family, and public health concern. They affect up to 30% of the population and often have a detrimental impact on functioning and quality of life. The overarching aim of IMMERSE (Implementing Mobile MEntal health Recording Strategy for Europe) is to improve mental health care in Europe and transform it into true person-centered care. We want to give people an active role in their treatment process and involve service users in the decisions regarding their treatment. In order to achieve this, we have identified the Experience Sampling Methodology (ESM), a structured diary technique, as the methodology that puts the service user at the heart of their treatment. IMMERSE integrates 20 years of research evidence on ESM into an innovative, clinical digital health tool - the DMMH (Digital Mobile Mental Health), in close collaboration with stakeholders (service users, their support network, clinicians and hospital management). The DMMH consists of an ESM app (the MoMent app) that individuals use to assess their mood, symptoms and treatment targets in their daily lives and the MoMent dashboard, where the data are visualised. Mobile sensing data is gathered to develop sophisticated machine learning models, aiming to improve personalised visualisations and feedback. IMMERSE aims to thoroughly evaluate how the DMMH can be implemented in routine mental health care as well as whether it is effective, by running a clustered randomised clinical implementation trial at 8 sites in 4 countries in Europe. Similarly, IMMERSE aims to identify key barriers and facilitators for implementation, by closely collaborating with relevant stakeholders, and aligning the innovative intervention to their needs. The diverse ethical, legal and policy challenges and requirements are being identified and DMMH has been developed and implemented accordingly. Finally, IMMERSE sets out to do a cost-benefit analysis of the implementation and present a framework for future implementation of DMMH.
WP2 developed the DMMH (MoMent App and MoMent Dashboard), integrating the visualisations of the basic statistics (WP4). The DMMH was developed under Quality Management Systems, in order to comply with the Medical Device regulatory framework, as being outlined by WP6. A usage tracking system was implemented to monitor compliance and usage of the MoMent Dashboard for clinicians. WP3 created the data management plan, the data integration structure as well as the eCRF. A secure storage space has been created behind the firewall of UKER to store the weekly backups of the exported data. WP4 has developed and validated a novel recurrent neural network-based model for integrating multimodal time series, to reconstruct underlying dynamical systems. WP4 also developed and benchmarked a hierarchization framework to integrate data across different users. WP5 together with WP7 conducted surveys and semi-structured interviews with different stakeholders to 1) identify barriers, facilitators and catalysts for implementation, 2) determine actionable requirements to ensure good user experience, and 3) investigate planned implementation strategies. WP6 has developed a data governance framework and analysed the regulatory landscape for digital health. WP7 developed implementation strategies aimed at clinicians, service users and hospital management. WP7 also started the clustered randomised trial. By the end of this reporting period, 315 inclusions were reached (73% of the total sample). The implementation process evaluation is currently being conducted. Finally, WP7 developed the overall study protocol for the economic evaluation and a time recording template for clinicians. WP8 has set up the Exploitation Steering Group, which is working on developing a business model and on preliminary IP due diligence. In addition, a dissemination and exploitation plan has been developed, which included a market analysis and strategy report for DMMH-like applications.
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.
• 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.