Periodic Reporting for period 1 - IMMERSE (The implementation of Digital Mobile Mental Health in clinical care pathways: Towards person-centered care in psychiatry)
Okres sprawozdawczy: 2021-04-01 do 2022-09-30
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 therefore to improve mental health care in Europe and transform it into true person-centered care which is focused on the needs of each individual. 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 the daily life and the MoMent dashboard, where the data are visualised. Furthermore, mobile sensing data is gathered to develop sophisticated machine learning models, aiming to improve the 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. At the same time, IMMERSE aims to identify key barriers, facilitators and catalysts for implementation, by closely collaborating with relevant stakeholders, aligning the innovative intervention to their needs. Similarly, the diverse ethical, legal and policy challenges and requirements are being identified and DMMH has been developed and implemented accordingly. Finally, IMMERSE is set out to do a cost-benefit analysis of the implementation and present a framework for future implementation of DMMH.
Phase 1 of IMMERSE has been conducted and finished whereas the start of phase 2 has been prepared. Phase 1 constituted the preparatory phase for the clustered randomised implementation trial in phase 2. WP1 has worked on both the internal and external communication tools for the consortium. WP2 has developed the DMMH consisting of the 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. WP3 created the data management plan, the data integration structure as well as the eCRF. WP4 has developed and validated deep time series models, to efficiently integrate data over different modalities. 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. The analysis of a subset of the data informed the further development of DMMH (WP2). WP6 has developed a data governance framework, including a Joint Controller Agreement, and a Data Processing Agreement for Phase 1 and Phase 2. In addition, WP6 helped with preparing the ethics package for Phase 1 and Phase 2. WP7 worked on a technology implementation strategy, by providing a requirement document for the DMMH intervention as well as conducting usability tests. Furthermore, WP7 developed implementation strategies aimed at clinicians, at service-users and at the level of the organization. WP7 also developed the first study participant approval package. WP7 prepared the interview guide for the implementation process evaluation, and the appropriate questionnaire for the economic evaluation has been selected. This means that phase 1 is now complete and the consortium is ready to start with phase 2. All sites are ready to enroll their first participants in the first weeks of November. Finally, WP8 has created the Exploitation Steering Group. In addition, a dissemination and exploitation plan has been developed.
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. IMMERSE has already done extensive usability testing before the start of the RCT in phase 2. Furthermore, we will conduct an RCT and test 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 will get feedback on personalized patterns of associations, thus providing a granular understanding of real-life processes, including their mental health problems and the context thereof. Furthermore, using the DMMH will restore the power-balance by empowering service users to come in the lead of their treatment process
• Technology Only a small proportion of apps uses passive sensor information and an even smaller number uses advanced statistics such as machine learning models. In the IMMERSE project, we are integrating passive sensor information with the self-report data and we are currently developing and validating deep time series models integrating multi-modal data. These models will move beyond state-of-the-art ML approaches as they will 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 (Eudemed number CIV-22-08-040547). Also, FHIR specifications for interoperability with the international research community as well as integration capability with hospital systems has been provided, in order to work on the transfer from research app to a medical device.
• Implementation and scalability Very little research has been conducted on the implementation of mobile health solutions in mental health. 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, will allow investigating implementation processes and outcomes as well as cost-effectiveness.
• 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. IMMERSE has already done extensive usability testing before the start of the RCT in phase 2. Furthermore, we will conduct an RCT and test 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 will get feedback on personalized patterns of associations, thus providing a granular understanding of real-life processes, including their mental health problems and the context thereof. Furthermore, using the DMMH will restore the power-balance by empowering service users to come in the lead of their treatment process
• Technology Only a small proportion of apps uses passive sensor information and an even smaller number uses advanced statistics such as machine learning models. In the IMMERSE project, we are integrating passive sensor information with the self-report data and we are currently developing and validating deep time series models integrating multi-modal data. These models will move beyond state-of-the-art ML approaches as they will 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 (Eudemed number CIV-22-08-040547). Also, FHIR specifications for interoperability with the international research community as well as integration capability with hospital systems has been provided, in order to work on the transfer from research app to a medical device.
• Implementation and scalability Very little research has been conducted on the implementation of mobile health solutions in mental health. 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, will allow investigating implementation processes and outcomes as well as cost-effectiveness.