Exploring Emotional Intelligence and Cognitive Flexibility in Anorexia Nervosa and Parkinson's Disease.

Recruiting

• Conditions: Anorexia Nervosa; Parkinson Disease
• Interventions: Diagnostic Test: Neuropsychological tests in PD; Diagnostic Test: Neuropsychological tests in AN; Diagnostic Test: Self-report questionnaires in PD; Device: International Affective Picture System (IAPS); Diagnostic Test: Self-report questionnaires in AN; Diagnostic Test: Analysis of bio-humoral parameters

• Registration Number: NCT06323564
• Lead Sponsor: Istituto Auxologico Italiano

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.

Study Timeline

• Study Start: 2023-01-13
• Status Verified: 2024-03
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-14
• Last Update Submitted: 2024-03-14
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21
• Primary Completion: 2024-08-13
• Study Completion: 2025-01-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anorexia Nervosa (AN)	Neuropsychological tests in AN	The trial will be divided into two periods T0 (first evaluation at the time of admission to hospital) and T1 (4 weeks after T0, during rehabilitation period in hospital. First, as soon as patients are admitted to acute care, neuropsychological tests and self-report questionnaires will be administered. Subsequently, at both T0 and T1, standardized emotional images from the International Affective Picture System (IAPS) will be administered. For the entire duration of the test, peripheral physiological parameters such as ECG, BVP, GSR, EOG, RSP and facial EMG (corrugator and zygomaticus) will also be detected, as objective measures of emotional arousal (T0-T1). Furthermore, the analysis of bio-humoral parameters (interleukin 6, cortisol, serotonin, catecholamines and endorphins) will be also performed through morning venous blood sampling at T0, at half of the rehabilitation process and at T1.
Parkinson Disease (PD)	International Affective Picture System (IAPS)	The trial will be divided into two periods T0 (first evaluation at the time of admission to hospital) and T1 (15 days after T0, during rehabilitation period in hospital for patients with Parkinson's disease). First, as soon as patients are admitted to acute care,neuropsychological tests and self-report questionnaires will be administered. Subsequently, at both T0 and T1, standardized emotional images from the International Affective Picture System (IAPS) will be administered. For the entire duration of the test, peripheral physiological parameters such as ECG, BVP, GSR, EOG, RSP and facial EMG (corrugator and zygomaticus) will also be detected, as objective measures of emotional arousal (T0-T1).
Anorexia Nervosa (AN)	International Affective Picture System (IAPS)	The trial will be divided into two periods T0 (first evaluation at the time of admission to hospital) and T1 (4 weeks after T0, during rehabilitation period in hospital. First, as soon as patients are admitted to acute care, neuropsychological tests and self-report questionnaires will be administered. Subsequently, at both T0 and T1, standardized emotional images from the International Affective Picture System (IAPS) will be administered. For the entire duration of the test, peripheral physiological parameters such as ECG, BVP, GSR, EOG, RSP and facial EMG (corrugator and zygomaticus) will also be detected, as objective measures of emotional arousal (T0-T1). Furthermore, the analysis of bio-humoral parameters (interleukin 6, cortisol, serotonin, catecholamines and endorphins) will be also performed through morning venous blood sampling at T0, at half of the rehabilitation process and at T1.
Parkinson Disease (PD)	Neuropsychological tests in PD	The trial will be divided into two periods T0 (first evaluation at the time of admission to hospital) and T1 (15 days after T0, during rehabilitation period in hospital for patients with Parkinson's disease). First, as soon as patients are admitted to acute care,neuropsychological tests and self-report questionnaires will be administered. Subsequently, at both T0 and T1, standardized emotional images from the International Affective Picture System (IAPS) will be administered. For the entire duration of the test, peripheral physiological parameters such as ECG, BVP, GSR, EOG, RSP and facial EMG (corrugator and zygomaticus) will also be detected, as objective measures of emotional arousal (T0-T1).
Parkinson Disease (PD)	Self-report questionnaires in PD	The trial will be divided into two periods T0 (first evaluation at the time of admission to hospital) and T1 (15 days after T0, during rehabilitation period in hospital for patients with Parkinson's disease). First, as soon as patients are admitted to acute care,neuropsychological tests and self-report questionnaires will be administered. Subsequently, at both T0 and T1, standardized emotional images from the International Affective Picture System (IAPS) will be administered. For the entire duration of the test, peripheral physiological parameters such as ECG, BVP, GSR, EOG, RSP and facial EMG (corrugator and zygomaticus) will also be detected, as objective measures of emotional arousal (T0-T1).
Anorexia Nervosa (AN)	Self-report questionnaires in AN	The trial will be divided into two periods T0 (first evaluation at the time of admission to hospital) and T1 (4 weeks after T0, during rehabilitation period in hospital. First, as soon as patients are admitted to acute care, neuropsychological tests and self-report questionnaires will be administered. Subsequently, at both T0 and T1, standardized emotional images from the International Affective Picture System (IAPS) will be administered. For the entire duration of the test, peripheral physiological parameters such as ECG, BVP, GSR, EOG, RSP and facial EMG (corrugator and zygomaticus) will also be detected, as objective measures of emotional arousal (T0-T1). Furthermore, the analysis of bio-humoral parameters (interleukin 6, cortisol, serotonin, catecholamines and endorphins) will be also performed through morning venous blood sampling at T0, at half of the rehabilitation process and at T1.
Anorexia Nervosa (AN)	Analysis of bio-humoral parameters	The trial will be divided into two periods T0 (first evaluation at the time of admission to hospital) and T1 (4 weeks after T0, during rehabilitation period in hospital. First, as soon as patients are admitted to acute care, neuropsychological tests and self-report questionnaires will be administered. Subsequently, at both T0 and T1, standardized emotional images from the International Affective Picture System (IAPS) will be administered. For the entire duration of the test, peripheral physiological parameters such as ECG, BVP, GSR, EOG, RSP and facial EMG (corrugator and zygomaticus) will also be detected, as objective measures of emotional arousal (T0-T1). Furthermore, the analysis of bio-humoral parameters (interleukin 6, cortisol, serotonin, catecholamines and endorphins) will be also performed through morning venous blood sampling at T0, at half of the rehabilitation process and at T1.

Primary Outcome Measures

Name	Time	Method
Change in International Affective Picture System (IAPS)	At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)	Self-Assessment Manikin (SAM) scale. Range score for each image: 1-5 (IAPS test: 24 blocks of 2 minutes and for each block there will be 12 images of 10 seconds each).

Secondary Outcome Measures

Name	Time	Method
Change in Heart rate variability	At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)	High frequency (range 0.15-0.40 hz); * Low frequency (range 00.4-0.15 hz); * Ratio Low frequency/High frequency
Change in self-report questionnaires - STAI	At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)	State-Trait Anxiety Inventory (STAI); score range 20-80
Change in analysis of bio-humoral parameters	At baseline T0 (hospital admission), after 2 weeks and T1 (4 weeks after T0 for AN)	Serotonin in serum (range 30 - 200 ng/ml)
Change in self-report questionnaires - BDI	At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)	Beck's Depression Inventory (BDI); score range 0-63

Trial Locations

Locations (1)

Istituto Auxologico Italiano; 🇮🇹 Oggebbio, Italy