- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06323564
Exploring Emotional Intelligence and Cognitive Flexibility in Anorexia Nervosa and Parkinson's Disease. (INTELLEGO)
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 Overview
Status
Conditions
Intervention / Treatment
- Diagnostic test: Neuropsychological tests in PD
- Diagnostic test: Self-report questionnaires in PD
- Device: International Affective Picture System (IAPS)
- Diagnostic test: Neuropsychological tests in AN
- Diagnostic test: Self-report questionnaires in AN
- Diagnostic test: Analysis of bio-humoral parameters
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Riccaro Cremascoli, MD, PhD
- Phone Number: +393497292068
- Email: r.cremascoli@auxologico.it
Study Locations
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Oggebbio, Italy, 28824
- Recruiting
- Istituto Auxologico Italiano
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Contact:
- Riccardo Cremascoli, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Parkinson Disease (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). |
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).
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).
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).
|
Anorexia Nervosa (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. |
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).
Verbal Fluencies, Tower of London, TMT-A & B
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).
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in International Affective Picture System (IAPS)
Time Frame: At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
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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).
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At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self-report questionnaires - STAI
Time Frame: At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
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State-Trait Anxiety Inventory (STAI); score range 20-80
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At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
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Change in self-report questionnaires - BDI
Time Frame: At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
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Beck's Depression Inventory (BDI); score range 0-63
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At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
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Change in Heart rate variability
Time Frame: At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
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High frequency (range 0.15-0.40 hz)
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At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
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Change in analysis of bio-humoral parameters
Time Frame: At baseline T0 (hospital admission), after 2 weeks and T1 (4 weeks after T0 for AN)
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Serotonin in serum (range 30 - 200 ng/ml)
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At baseline T0 (hospital admission), after 2 weeks and T1 (4 weeks after T0 for AN)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Signs and Symptoms, Digestive
- Feeding and Eating Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Anorexia
- Anorexia Nervosa
- Parkinson Disease
Other Study ID Numbers
- 21C223
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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