The PSYCHE (Personalised monitoring SYstems for Care in mental HEalth) project develops a personal, cost-effective, multi-parametric monitoring system based on textile platforms and portable sensing devices for the long-term and short-term acquisition of data from selected class of patients affected by mood disorders.

The patient diagnosed with bipolar disorder will be placed at the centre of its management, for treatment and prevention of depressive and manic episodes. The system will use wearable and portable devices for acquiring, monitoring and communicating physiological parameters, behavioural and mood correlated indexes (i.e. vital body signs, biochemical markers and voice analysis).

The data acquired will be processed and analysed in the established platform that takes into consideration the Electronic Health Records (EHR) of the patient, the parameters set up in the first stage between bipolar and non-bipolar individuals, as well as medical analysis in order to verify the diagnosis and help in prognosis of the illness.

Communication and feedback to the patient will be performed through a direct contact with the patient and device, or by communication between doctor and patient. Constant feedback and monitoring will be used to manage the illness, to give patients support, to facilitate interaction between patient and doctor as well as to alert professionals in case of a patient’s relapse and of depressive or manic episodes.

PSYCHE will focus on the following objectives:

• Implementation of a sensing platform for physiological and behavioural monitoring for patients with bipolar disorders;
• Development of novel portable devices for the monitoring of biochemical markers, voice analysis and a behavioural index correlated to mental illness;
• Brain functionality: in order to correlate central measures with clinical assessment and the parameters measured by the PSYCHE platform;
• Data mining and managing: The ultimate goal is to identify signal trends indicating detection and prediction of critical events;
• The system will contain a patient and professional closed loop.

Policy Context

The project is funded under 7th FWP (Seventh Framework Programme), Research area: ICT-2009.5.1 Personal Health Systems.

Description of target users and groups

The project includes two studies with different patient recruitment. Study 1 aims at the prediction of response to treatment in 10 bipolar patients. Study 2 aims at the prediction of mood fluctuations in 6 patients with rapid-cycling bipolar disorders, 4 patients with cyclothymic disorders, and 6 patients with cyclothymic temperaments.

The protocol is supposed to last 14 weeks with two levels of monitoring. Level 1 is based on daily routine monitoring including Mood/sleep agenda and voice recording through the smartphone. Level 2 is a based on twice a week at home monitoring including mood self assessment with Bauer ISS (smartphone), voice recording while commenting a picture (smartphone), night recording through the textile platform, sleep diary (in the morning), clinical evaluation (through hospital visit and phone interview), clinician mood assessment (YMRS, QIDS-C16).

Description of the way to implement the initiative

The project’s activities are organised into the following eight work packages:

WP1: Users and system requirements

The work package has the following objectives:

• Definition of the protocols for signal acquisition;
• Identification and development of computerised cognitive mood and emotional tests;
• Definition of user needs and system requirements;
• Definition of testing protocols for clinical validation.

WP2: Hardware platform for multi-parametric monitoring

The work package is responsible for the implementation of the remote sensing platform and instrumented patches, the sensor modules, real-time algorithms and the portable devices to gather parameters correlated to psycho-emotional patient status. Different systems will be delivered for laboratory and naturalistic monitoring, for day and night use. Each system includes textile and non-textile sensors, and wearable electronics with the aim to increase the number of acquired physiological and mood correlated measurements without interfering with the patients in terms of comfort as well as motivation. This WP will provide state-of-the-art technology to be used during the Acquisition Phase in laboratory and natural environment to build the database for the implementation of the software for the PSYCHE platform.

WP3: Signal processing and parameter extraction

One of the main objectives of this project is to relate physiological and behavioural signals to bipolar state in order to derive a quantitative and measurable indicator of this state. The first step for the derivation of such an indicator is to extract relevant features from measured signals. The analysis for the feature extraction will be based on models which describe how the nervous system regulates the values of the measured signals in different environment conditions and how bipolar disorder may affect this regulation process. This WP is required to define, to implement and to verify several methods of signal and data processing of peripheral and central physiological signals, including activity and gesture, biochemical data, ECG EMG, EOG, respiration activity, internal temperature and clinical evaluations. The objective is to identify a set of parameters related to the bipolar state. Among the identified parameters a subset will be chosen that will be the candidate for the implementation on the naturalistic environment monitoring system. The final aim is to provide tools that are a decision-making support for the early identification of the state changes in the daily life environment of the patient.

WP4: Data mining and data managing

The goal of this work package is to design and develop a proper DSS that will make it possible to interpret the patient bioinformation, to assist the doctor in their decision and to interact with the patient behaviour. This work package is also responsible for the development and implementation of algorithm for acquiring structural data, knowledge discovery and knowledge interpretation by using methods from artificial intelligence, machine learning, statistics, and research on databases. The work package will define and implement intelligent techniques to predict patient evolutions and define possible solution before irreparable events. The work package will provide visual information interpretation and interpretation to support medical professionals, healthy interested persons and relatives as well as patients suffering in bipolar disorders.

WP5: User and professional Interface

WP5 aims at designing and developing the user-interaction workflows and the user interfaces for both patients and professionals. User-interaction design is based on the creation of user models that drive the development of the interaction solutions. These models are based on the definition of a comprehensive set of parameters that describe the status of the patient in a specific moment in time, which set of parameters and the environmental conditions are defined in the frame of WP1 activity. The accuracy of these parameters is especially important when designing for bipolar patients, as the interaction depends on whether the patients is in a depressive mood or entering a maniac phase, which can be controlled via the index of bipolar state. Moreover, when designing user interaction for chronic patients, it is important not to focus only on the patient, but to perform a holistic approach that takes into account the patient’s social, medical and professional environments.

WP6: Validation through clinical application

The first goal of this work package is to document the ability of the PSYCHE system to predict significant clinical events in patients with bipolar mood disorders, such as:

• response to treatment;
• recurrence of a new episode or of a period at risk of recurrence or of mood changes.

The second goal of this work package is to document the acceptability and the usability of the PSYCHE system by the patients suffering from bipolar disorders.

WP7: Dissemination and business assessment

The objective of this work package is to protect project results, to manage communication of the results to the user community, and to ensure market awareness of PSYCHE. It will be organised into the following streams of activity:

• intellectual properties management;
• dissemination of scientific results;
• dissemination and financial exploitation through the community-web2.0;
• preparation for commercialisation of PSYCHE results.

WP8: Project management

The objective of this WP is twofold:

• to plan, monitor and apply corrective actions in response to deviations concerning project work and resources;
• to manage all communication between project consortium and the Commission.

Main results, benefits and impacts

Objectives

The goal of PSYCHE is to provide a system that aims at empowering bipolar patients to take control of their own health status, providing educational content and providing a continuous assessment of the patient’s mood both for patients and health professionals, and promoting the communication between patients, their peers and health professionals.

PSYCHE project will focus on the following objectives:

• Integration of sensors for physiological and behavioural data into a monitoring system for patients affected by bipolar disorders.
• Development of novel portable devices for the monitoring of biochemical markers, voice analysis and a behavioural index correlated to mental illness. Special emphasis will be placed on the reliability of these systems and user acceptability.
• Implementation of an integrated system to collect data from bipolar patients. Bipolar patients in different states of the illness (mania or depression episodes, remission) will be considered.
  Controlled environments enable the concurrent assessment of patient status by the medical professionals who are used to annotate the recorded signals. The collected data along with the subjective annotations are recorded in a reference database, where information from the EHR such as medication, patient history and exams, will be integrated. Semantic technologies will be exploited to enable content-based searches.
• Data managing: the large amount of data will be analysed using state-of-the-art signal processing and data mining methods to correlate patient status assessment (from health professional annotations and other clinical findings) with the measured parameters. The ultimate goal is to identify signal trends indicating detection and prediction of critical events.
• User interface: once the group of patients has been selected, the most adequate input and feedback methods will be defined. Adequate devices will be chosen depending on user needs and expectations, and therefore different dialogue strategies will be defined depending on the selected devices and interaction techniques. Different techniques will be studied in order to adapt the information and presentation to the use scenarios.
• Professional interface: mental health professionals involved in PSYCHE will perform patient monitoring tasks. A user-friendly environment will be developed where, through easily formulated queries, medical professionals will be able to view current patient data as well as information extracted from electronically stored medical files. Embedded system intelligence will allow for the modelling and prediction of patient status and will be used for the development of an alert mechanism to identify situations requiring special attention.

 

Impact

PSYCHE impacts on many areas:

• Quality of life
  The goal of PSYCHE Project is to propose a model for a daily and night monitoring of the bipolar patients with a naturalistic approach, by designing an integrated platform provided with software tools and technologies for tele-care. This support will be provided by connecting in-hospital care of the acute syndrome with out-of-hospital follow-up by patient/family caregiver monitoring, associated with supervised care, and with a direct linkage with specialist advising.
• Disease management
  PSYCHE contributes to the following aspects:
• Improve the links and interaction between patients and doctors facilitating more active participation of patients as well as their relatives in care processes;
• Provide higher quality of interaction between doctor and patient, and the information exchange between the two, are therefore essential for the effective care of this chronic disease.
• Social impact
  The social impact of personalised monitoring systems based on wearable technology starts from a better possible diagnosis, due to the fact that patients live their daily life and are not perturbed psychologically by the hospital environment, up to saving economic resources by the efficient monitoring of risk subjects, the continuous control of therapy effectiveness in the daily life environment of the patient, the reduction in hospitalisation costs.
• Technology
  Innovation in the personal health systems sector. One of the main objectives of the project is to foster the new market of the personalised healthcare systems based on the combination of smart textiles and innovative ICT solutions.
• Standardisation
  To assure usability and potential exploitation of results in different national contexts, the project requires, on the one hand, a European approach, on the other the use of international health care standards.
  In addition to the existing standards, the PSYCHE application will be based also on new standards for the most innovative solution proposed in the frame of the project such as the textile interfaces, the
  interconnection textile compatible solutions (bus and connectors), the new packaging of the electronics to be embedded in the textile interface.
• Scientific research through an interdisciplinary approach
  PSYCHE will contribute to the scientific development of ICT as applied to health domains and as mentioned above this project is one of the first focussed on the field of mood disorders with the perspective of further development for other mental disorders.

Return on investment

Return on investment: Not applicable / Not available

Track record of sharing

The project is intended to be a pilot study on voluntary patients, but if results are promising the final PSYCHE platform could be included in the current clinical practice to provide the clinicians with more objective cues in support of their prognosis and diagnosis. We are going to build a database of data collected from patients using the PSYCHE platform and, in principle, it could be shared with other professionals or researchers.

Lessons learnt

Many lessons can be learnt from the PSYCHE project. The three main ones are:

1. Confirmation of the hypothesis of a correlation between parameters related to the autonomic nervous systems and mental disorders. Indeed, the current literature is quite controversial on this point, and although several works support this conjecture, none applied a multiparamteric approach within a structured study like the PSYCHE project.
2. Comfortable wearable long-term monitoring systems used in a naturalistic environment dramatically increase patient compliance and effectiveness of the decision support system. Nevertheless, high intra- and inter- subject variability have to be carefully considered.

Advanced signal processing techniques allowed us to characterise pathological mental states with high accuracy. However, a good compromise between high level of mathematical abstraction and real knowledge of psychophysiology has to be carefully considered. The decision support system, indeed, can be effective regardless of the neuro-biological bases underlying the mental illness.

Scope: International