Clinical trial NCT06323564: Exploring Emotional Intelligence and Cognitive Flexibility in Anorexia Nervosa and Parkinson's Disease.
Official title: Exploring How Emotional Intelligence and Cognitive Flexibility Affect the Measurement of Emotional Valence and Arousal in Two Populations: Patients With Anorexia Nervosa and Parkinson's Disease.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anorexia Nervosa
Parkinson Disease
Keywords: Emotional intelligence
Cognition
Emotional valence
Anorexia nervosa
Parkinson's disease
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by Parkinson's Disease and Anorexia Nervosa

Brief summary: The main aim of this study is to demonstrate how disorders characterized by different types of "inflexibility", cognitive-affective type for Anorexia nervosa and motor one for Parkinson's disease, have an impact on how emotional stimuli are processed and on the transition within emotional states.

Detailed description: Although many psychometric models have been developed on emotions, affect measurements, which represent the measurement of behavioural, subjective and neuropsychophysiological changes associated with an emotional episode, still remains one of the most debated topics. Emotions are entities with blurred boundaries and with substantial idiosyncrasies that characterize their measurable manifestations. One of the most consolidated theoretical reference models for measuring affect is that of James Russel called the "Affective Core Model". According to this model, emotion arises when the undifferentiated and pre-reflective magma of affect (core affect) is attracted by an external (or internal) object that can be defined as emotigenic, i.e. capable of defining the nature of emotional experience by orienting it along two dimensions principal factors. The most used theoretical model for affect measurement is the one that describes an emotional episode in the light of two distinguishable continuous dimensions: that of hedonic value (identifies the degree of pleasantness of the emotional event), of a subjective nature, and that of arousal or psychophysiological activation. Although this model has been widely corroborated in various disciplines, there is still a lack of a clear description of the process that allows an individual to transition from one emotionally object-oriented state to another.

This project proposes and intends to validate a new modality of three-dimensional psychometric modeling of emotions, based on the intersection between the consolidated two-dimensional model of arousal-valence and a third purely cognitive component definable as mental flexibility, capable of including high-level cognitive processes, intrinsically connected with the emotional sphere, such as emotional intelligence (Emotional Intelligence, EI) and emotional regulation.

Eligibility criteria: Inclusion Criteria:

* Parkinson's Disease
* Anorexia nervosa
* Written informed consent

Exclusion Criteria:

* Other psychiatric disorders
* Acute infectious diseases
* Chronic inflammatory diseases
* Other Disorders of central nervous system
* Pregnancy or breastfeeding
* tachy or bradyarrhythmias, other cardiac rhythm alterations that compromise the study of heart rate variability

Primary outcomes:
measure: Change in International Affective Picture System (IAPS)
timeFrame: At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
Secondary outcomes:
measure: Change in self-report questionnaires - STAI
timeFrame: At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
measure: Change in self-report questionnaires - BDI
timeFrame: At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
measure: Change in Heart rate variability
timeFrame: At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
measure: Change in analysis of bio-humoral parameters
timeFrame: At baseline T0 (hospital admission), after 2 weeks and T1 (4 weeks after T0 for AN)
Other outcomes:
Locations:
city: Oggebbio
country: Italy
facility: Istituto Auxologico Italiano
Study officials:
References: