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

Parkinson Disease Clinical Trial

— INTELLEGO  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06323564
• Other study ID #: 21C223
• Status: Recruiting
• Start date: January 13, 2023
• Est. completion date: January 13, 2025

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Riccaro Cremascoli, MD, PhD
• Phone: +393497292068
• Email: r.cremascoli[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 13, 2025
• Est. primary completion date: August 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Parkinson Disease

Intervention

Diagnostic Test:
• Neuropsychological tests in PD
Colored Progressive Matrices (BDM), Stroop Test (Caffarra et al., 2000), Stroop Test (Caffarra et al., 2000), Attentional Matrices (part I - Della Sala et al., 1992), Attentional Matrices (part The - Della Sala et al., 1992), Trail Making Test (Giovagnoli et al., 1996 - part A), Trail Making Test (Giovagnoli et al., 1996 - part B), Trail Making Test (Giovagnoli et al., 1996 - B-A), MMSE (Grigoletto et al., 1999), Clock Drawing - PD (Caffarra et al., 2011), Digit Span Forward (Orsini et al., 1987), Digit Span Backward (Monaco et al. , 2012), 15 Rey Words - Immediate Recall (BDM), 15 Rey Words - Deferred Recall (BDM), Phonemic Fluency (Costa et al., 2014), Semantic Fluency (Costa et al., 2014), Frontal Assessment Battery ( FAB - Apollonio et al.,2005).
• Self-report questionnaires in PD
STAI Y2 (trait anxiety), TEIque (153 items), STAI Y1 (state anxiety), ERQ (10 items), EISR (33 items), BDI (21 items), WLEIS (16 ITEMS), CFI (20 ITEMS ), CCFQ (18 ITEM).

Device:
• International Affective Picture System (IAPS)
Subsequently, at both T0 and T1, standardized emotional images from the International Affective Picture System (IAPS) will be administered. The images will be chosen based on the arousal-valence parameters, eliminating those with stimuli that are too salient with respect to the disorders examined. The order of administration will be organized and randomized between subjects as follows: 24 blocks of 2 minutes and for each block there will be 12 images of 10 seconds each. 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).

Diagnostic Test:
• Neuropsychological tests in AN
Verbal Fluencies, Tower of London, TMT-A & B
• Self-report questionnaires in AN
STAI Y2 (20 items trait anxiety), TEIque (153 items), STAI Y1 (20 items state anxiety), DFlex (24 items), ERQ (10 items), EISR (33 items), BDI (21 items), TAS-20 (20 items), WLEIS (16 ITEMS), CFI (20 ITEMS), CCFQ (18 items).
• Analysis of bio-humoral parameters
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

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano	Oggebbio

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in International Affective Picture System (IAPS)	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).	At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
Secondary	Change in self-report questionnaires - STAI	State-Trait Anxiety Inventory (STAI); score range 20-80	At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
Secondary	Change in self-report questionnaires - BDI	Beck's Depression Inventory (BDI); score range 0-63	At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
Secondary	Change in Heart rate variability	High frequency (range 0.15-0.40 hz); Low frequency (range 00.4-0.15 hz); Ratio Low frequency/High frequency	At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
Secondary	Change in analysis of bio-humoral parameters	Serotonin in serum (range 30 - 200 ng/ml)	At baseline T0 (hospital admission), after 2 weeks and T1 (4 weeks after T0 for AN)