Integration of learning, body, and emotions in synergy - I-ACE.

Summary description of the study

The study on the integration of learning, body, and emotions in synergy (I-ACE) aims to evaluate the effectiveness of training in non-pharmacological therapies regarding the sense of overload among professionals caring for people with dementia residing in nursing homes. At the same time, three types of activities will be compared: training based on the rigorous methodology of applying non-pharmacological therapies; training that, in addition to the rigorous methodology, is based on reading body language as a prerequisite for emotional attunement during the progression of the disease and for each individual; the usual training and care activities. A saliva sample will also be collected to measure the hormone oxytocin, known as the relationship hormone. The innovative aspect of measuring the oxytocin hormone as a parameter of activating the predisposition to relationship in this study lies in its detection within a work aimed at more consciously activating the predisposition of caregivers to relational encounters with the person affected by dementia. The research also includes a sub-study, the San Rocco sub-protocol, in which the times and the number of professionals needed to implement non-pharmacological therapies will be calculated and in which training on the rigorous methodology of applying non-pharmacological therapies will be compared with the usual training and care activities.

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Intervention under investigation

I-ACE

Experimental group: training intervention on the I-ACE methodology

The intervention aims to integrate into the daily care of the PwD the methodological knowledge that aims to offer the tools to apply to the most used non-pharmacological intervention in the structure (or in case of absence, the TBE), with a "work on the body that heals with increasing awareness" that, activated in the concreteness of the daily life of the CpA, allows the reading of the subjective relational experience of the care situation by the caregiver and a comparison of shared readings of the situation itself by the group of colleagues, and with the resident individuals. The technique used consists of theatrical exercises guided by an experienced actor, re-read and re-signified in vivo with the help of a psychologist-psychotherapist who promotes the understanding and awareness of reading oneself in relation to the other (caregiver, resident, or family member).

Each team of the experimental group participates in 22 meetings:

● 2 meetings lasting 4 hours each for theoretical introduction (also on the tools for those who do not know them). In the context of frontal and interactive lessons, the following topics will be addressed: dementia and staging of dementia, psycho-behavioral disorders and their assessment, the meaning of the non-pharmacological approach, what a TNF is and the main TNFs.

● 10 supervision meetings lasting one and a half hours on the methodology of implementing the chosen non-pharmacological therapy, carried out through discussion/rethinking and revisiting concrete cases. For the first 5 months of intervention, the supervisions will take place monthly, subsequently every 5-6 weeks for a total duration of one and a half years. In the context of the supervisions/formations, concrete situations will be presented in the team that will take on new meaning through a re-reading from the theoretical horizon previously presented in the lesson, they will be rethought and discussed in the context of a consciously relational care, to then be declined in the concreteness of everyday life through gestures, behaviors, verbal and emotional modulations, in the welcome and listening to the uniqueness of each PwD.

● 10 meetings with monthly frequency lasting 2 hours each dedicated to work on the "healing body". The first 4 meetings are based on exploring one's own body in relation through theatrical exercises. Starting from the most solid base, the body, through theatrical games, which are part of the actor's training, one will begin with the exploration of some of its inner components: breathing, the sound of the voice, muscle tensions. The aim is to stimulate and savor in oneself a quality of presence. Recognizing and developing tools that promote the well-being of the caregiver, thus accompanying participants in exploring communicative and listening skills to find new modalities and confirm already effective ones. The attentive gaze, the contact between eyes, the observation of the other's breath, the touch of the hand, the position in space, the recognition of the dimension of the other's space, and the rhythm will be some of the other elements of our "tool" with which we will enrich our research, entering the field of relationship with the other. The entire intervention also aims to promote the development of a shared perspective and a common vocabulary to describe the characteristics and moments of relationship and interaction with the resident individuals to help each other among colleagues. Below are some examples of theatrical exercises used: meeting while respecting individual spaces; the gaze of the other: supporting and meeting them; meeting in the gaze; accompanying pairs without words; accompanying blind pairs; exercise with sticks in pairs, in threes, in groups; exercises of different graduality in deepening the knowledge of breathing; breathing with the other; breathing with fear, anger, cooperation; the body in the room; how do I open the door, how do I enter.

The other 6 meetings are based on the modality of body-emotional supervision starting from the standard approach (in addition to what is described in the standard approach, the meeting in the emotional relationship with each individual affected by dementia will be refined). After the first 4 meetings on the body, the same cases discussed with the standard methodology will be re-discussed with the body-emotional approach. The body meetings of I-ACE will alternate bi-weekly with the supervisions of the cases discussed with the standard methodology.

Active control group: training intervention on the standard methodology

The intervention aims to offer the methodological tools to apply to the most used non-pharmacological intervention in the structure or, in case it is not yet in place, the TBE. Each team of the active control group participates in 12 meetings:

● 2 meetings lasting 4 hours each for theoretical introduction (and also on the tools for teams that have not yet been using them, such as observational scales and the NPI-NH). In the context of frontal and interactive lessons, the following topics will be addressed: dementia and staging of dementia, psycho-behavioral disorders and their assessment, the meaning of the non-pharmacological approach, what a TNF is and the main TNFs.

● 10 supervision meetings lasting one and a half hours on the methodology of implementing the chosen non-pharmacological therapy, carried out through discussion of concrete cases. For the first 5 months of intervention, the supervisions will take place monthly, subsequently every 5-6 weeks for a total duration of one and a half years. In the context of the supervisions/formations, concrete situations will be presented in the team that will take on new meaning through a re-reading from the theoretical horizon previously presented in the lesson, they will be rethought and discussed in the context of a consciously relational care, to then be declined in the concreteness of everyday life through gestures, behaviors, verbal and emotional modulations, in the welcome and listening to the uniqueness of each PwD.

Active control group as usual

Each team of the active control group as usual continues the training and care activities and the non-pharmacological interventions already in use in the CpA without participating in the training.

San Rocco study sub-protocol

The study is divided into two phases. A first phase of training for professionals on the circularity of caring for the PwD, consisting of:

- 1 meeting of 4 hours on multidimensional assessment;

- 2 meetings of 3 hours on defining objectives for the person and choosing the intervention: experiential accompaniment of professionals to the reading of behavioral disturbance, identifying the objective of the TNF for each resident through case discussion;

- 2 meetings of 4 hours on defining protocols for administering TNFs within the framework of personalizing interventions;

- starting the administration of the identified TNFs;

- 4 meetings of 1.5 hours dedicated to accompanying the team in implementing the TNFs through supervision;

- one meeting of 1 hour for monitoring interventions.

Second phase: starting the case-control study phase.

In the Protected Housing Unit Casa San Rocco, the controls (20 caregivers and 18 PwD) will be selected from the larger group of usual active control of I-ACE. Each case will be paired with a control subject based on sex and the existing behavioral disturbance (PwD) and based on the professional role (caregivers).

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Disease under investigation

With this project, we aim to make the modalities of emotional and relational attunement between caregivers and people affected by dementia (PwD) living in residential facilities more conscious, in order to further improve the quality of care and accompaniment encounters, that is, the quality of life in nursing homes (CpA), by actively making reproducible by professionals the behaviors that promote good quality or avoid those that generate discomfort. PwD constitute almost 2/3 of the residents of nursing homes, and the communicative-relational dynamic is the privileged channel in the most advanced stages of neurodegenerative diseases, the only one that allows truly meeting the person affected by dementia (PwD) who, due to the disease, is no longer able to communicate verbally in an understandable way. The approach we propose is based on accompanying professionals to acquire the ability to read emotional-behavioral body language as a prerequisite for emotional attunement that allows opening up to the relationship with the person in their uniqueness and during the course of the disease. In the context of caring for and accompanying PwD living in residential facilities, our previous study (Pezzati et al. 2020; Vaccaro et al., 2020) has favored the recognition of the need for applying a rigorous methodology focused on personalizing the intervention, using multidimensional assessment tools, creating possibilities and capacities for building individualized and flexible goals and projects as the disease evolves. In the interconnection of circularity between research and clinical practice, new neuroscientific knowledge opens the possibility to further know and improve the modalities of communication and relationship between caregivers and elderly people living in facilities. With this experimentation, we want to provide professionals with knowledge of the emotional-behavioral reading of body language specifically aimed at improving the perceived sense of overload and also increasing the emotional recognition of oneself and others. Indeed, human beings build on innate bases the knowledge of themselves and the world, according to procedural and declarative categories. Procedural knowledge relates to the emotions underlying our actions, while declarative knowledge is the ability to give and derive meaning through language. Procedural knowledge concerns non-verbal communication and constitutes a system of rules that encompasses strong emotional activations and provides the basis for the subsequent development of declarative knowledge about oneself and others [Interpersonal Motivational Systems - IMS; (Liotti, 2001)]. The attunement that is built through mutual knowledge with another person creates the basis for a communication and relationship of mutual respect and effectiveness in practice. Training promotes in caregivers the reading of the relationship with the patient starting from verbal and non-verbal messages through both experiential and theoretical modules (Norfolk, Birdi, & Patterson, 2009). This reading allows opening a channel of communication emotionally and relationally attuned with each of the PwD who need to be met in the specificity of their being unique and in the way they express their internal emotional world and needs. It is therefore the caregiver who activates as a direct tool of accompaniment in the individual changes during the progression of the disease. Furthermore, to better explore the communicative-relational dynamic, neurosciences offer us another very important opportunity to investigate this dynamic of relational co-construction between the caregiver and the PwD, especially in this period of continuous use of personal protective equipment such as masks that cover the face: oxytocin (OT). OT is a hormone present at the peripheral level (salivary and plasma) that predisposes the person to social interactions (Love, 2014). The scientific literature has associated OT with the ability to identify and interpret social information in terms of attention to faces (particularly the eyes), increasing emotional recognition (Lahousen, Unterrainer, & Kapfhammer, 2019), increasing altruistic and cooperative responses, and decreasing stress and physical and psychological pain (Faraji et al., 2018; Fineberg & Ross, 2017; Jones, Barrera, Brothers, Ring, & Wahlestedt, 2017). Generally measured in experiments on social cognition in animals and humans, the innovative aspect of measuring OT as a parameter of activating the predisposition to relationship in this study lies in its detection within a work aimed at activating the predisposition of caregivers to relational encounters with the PwD (Fineberg & Ross, 2017; Lahousen et al., 2019). The above-described factors are involved in the psycho-behavioral reading of reality by the caregiver who daily experiences difficult situations in caring for the PwD. Facing behavioral disturbances (e.g., agitation, aggressive behavior, wandering, depression) translates at the experiential level into a complex of visual, auditory, visceral, and motor inputs that, through the activation of cortical networks, the limbic system, and neurotransmitters, produce automatic emotional responses that lead to reading the intentions of the other based on one's own emotional response, the sense of inadequacy, the feeling of not being supported, to the detriment of building and maintaining the relationship with the PwD. Since the training we propose aims to improve emotional recognition, we expect an increase in awareness in daily operations starting from the PwD and not from one's own emotional response. We therefore aim to explore the change in indicators of awareness in the relationship: reading the emotions of the other, sense of competence, work climate, and perception of the quality of life of the PwD. This study falls among the projects of complex experimentation as there is a sub-protocol, the San Rocco case-control study, which shares the usual control arm with the I-ACE study. The Fondazione Casa San Rocco has had a Protected Housing Unit dedicated to PwD with 18 beds since 2011. Thanks to participation in the clinical trial on the effectiveness of TBE (Pezzati et al. 2020; Vaccaro et al., 2020), there was the opportunity to introduce specific skills for managing behavioral disorders through TNF into the team. Subsequently, in addition to TBE, other non-pharmacological interventions (e.g., structured lunch, therapeutic bath, and horticulture) were introduced, and others were designed and planned based on the specific needs of individual residents. Through the San Rocco case-control study, we intend to define the commitment required in terms of time and number of professionals needed for the implementation of the interventions, we expect an improvement in the quality of life of the PwD, a reduction in behavioral disturbances, and an improvement in cognition in terms of the ability to relate to the environment and initiative, finally, the improvement of the overload experiences of formal and informal caregivers.

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Sponsor

Rita Pezzati Associazione Ginco Ticino

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Name of the authorising ethics committee (for multicentre studies, only the lead committee)

Ethics Committee Ticino

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Date of authorisation

09.08.2021

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Results of the trial