Intervention group

The intervention group will receive the NEVERMIND system in addition to TAU, which is described in detail in the next section. The NEVERMIND system is a multifaceted, two-component system that comprises a smart shirt and a user interface, in the form of a mobile application, to put patients at the centre of their health management. The system is a real-time decision support system, aiming to predict the severity and onset of depressive symptoms by modelling the well-being condition of patients based on physiological data, body movement, and the recurrence of social interactions.

The interface monitors the patient’s mental health daily and treats mental health issues as they arise. If a user displays symptoms of depression, they are directed to different levels of treatment in the application. Further targeted advice and care is provided if the user displays symptoms of depression, anxiety, or stress, either through targeted mindfulness or through the online cognitive behavioural therapy programme, Deprexis, provided by Gaia AG [18].

The user interface also includes an Avatar and a speech monitoring feature to synthetize the system’s messages. In addition, the interface can be personalised to suit the patient’s dietary requirements, exercise recommendations and preferences to provide lifestyle guidance to improve their physical health tailored to their primary somatic condition. This is set up by the treating physician who also enters medical details including weight, blood pressure, and type of condition into the system. Several components are readily available to the patient upon receiving the system (Fig. ​(Fig.1).1). Lifestyle factors included in the application include diet tips, including recipes, and information about physical activity, including practice exercises. Moreover, there is a section on sleep hygiene and two mindfulness practices per day, either 10 or 25 min long, which can be chosen by the patient.

Components freely available to the patients without activation

The smart shirt collects physiological data (biomedical data) including electrocardiogram (ECG), accelerometer data, and respiration data, from which biomedical features are extracted based on signal processing techniques. These features are from three categories: movement dynamics, ECG-heart rate variability, and respiration dynamics.

The patients are encouraged to use the shirt as much as they like but must use it for a minimum of twice a week. The combined data from the interface and the shirt will trigger different responses encouraging patients to perform or alter activities and lifestyle choices to reduce the occurrence and severity of depressive symptoms based on their likelihood of developing depressive symptoms. Based on the general state of the patients, they can be directed to different levels of care as outlined below.

The levels of care (LC) are:

LC0: Positive feedback for individuals who are managing their mental health and well-being well.

LC1: Behavioural advice for those showing initial symptoms of depression, anxiety, or stress.

LC2: Targeted mindfulness if mild or moderate symptoms of depression, anxiety, or stress.

LC3: Online cognitive behavioural therapy, Deprexis, for those with moderate or severe symptoms of depression, anxiety, or stress.

LC4: The treatment team will be contacted if patient displays severe symptoms of depression or insomnia for several days in a row.

LC5: Emergency information and contact of the treatment team if the patient has suicidal intent.

If patients are not responding to a specific treatment and are still reporting depressive symptoms after four weeks, they will be asked if they wish to change to another LC. All patients will receive the NEVERMIND system for 12 weeks. Furthermore, each patient in the intervention group will receive a medical consultation regarding diet, physical activity, sleep, and an introductory session to mindfulness.

To encourage the use of the system and to measure adherence, the system has a compliance monitoring system. If a patient is inactive for three days, that is, not answering the daily questions for three days, a reminder will be sent to the patient. If the user is inactive for seven days, that is not using the system for seven days, the user will receive another reminder and the treatment team will be notified, and they will contact the user to ask the reason for inactivity. If the reason for inactivity is the inability to manage their depressive symptoms, the users will be referred to further treatment.