Anorexia NervosaINTELLEGONCT06323564
Exploring Emotional Intelligence and Cognitive Flexibility in Anorexia Nervosa and Parkinson's Disease.
An observational study of Anorexia Nervosa and Parkinson Disease, run by Istituto Auxologico Italiano at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anorexia Nervosa, Parkinson Disease
- What is being tested?
- Neuropsychological tests in PD, Self-report questionnaires in PD and International Affective Picture System (IAPS)
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jan 2023to 13 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by Parkinson's Disease and Anorexia Nervosa
Who may be able to join
- Parkinson's Disease
- Anorexia nervosa
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano
Oggebbio, 28824
Riccardo Cremascoli, MD, PhD
About this study
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.
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.
Read the 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.
- Conditions
- Anorexia Nervosa, Parkinson Disease
- Being tested
- Neuropsychological tests in PD, Self-report questionnaires in PD, International Affective Picture System (IAPS), Neuropsychological tests in AN, Self-report questionnaires in AN
- Keywords
- Emotional intelligence, Cognition, Emotional valence, Anorexia nervosa, Parkinson's disease
- Medical subject headings
- Anorexia Nervosa, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological tests in PDDiagnostic test
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 PDDiagnostic test
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).
International Affective Picture System (IAPS)Device
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).
Neuropsychological tests in ANDiagnostic test
Verbal Fluencies, Tower of London, TMT-A \& B
Self-report questionnaires in ANDiagnostic test
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 parametersDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Neuropsychological tests in PD; Diagnostic Test: Self-report questionnaires in PD; Device: International Affective Picture System (IAPS) | |
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
Secondary outcomes (4)
Change in self-report questionnaires - STAI
State-Trait Anxiety Inventory (STAI); score range 20-80
Measured: At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
Change in self-report questionnaires - BDI
Beck's Depression Inventory (BDI); score range 0-63
Measured: At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
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
Measured: At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
Change in analysis of bio-humoral parameters
Serotonin in serum (range 30 - 200 ng/ml)
Measured: At baseline T0 (hospital admission), after 2 weeks and T1 (4 weeks after T0 for AN)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start13 Jan 2023
- Primary completion13 Aug 2024 (estimated)
- Study completion13 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323564
- Sponsor's protocol ID
- 21C223
- Acronym
- INTELLEGO
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06323564
- Acronym / sponsor ID
- INTELLEGO / 21C223
- Conditions
- Anorexia Nervosa, Parkinson Disease
- Keywords
- Emotional intelligence, Cognition, Emotional valence, Anorexia nervosa, Parkinson's disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 13 Aug 2024 (estimated)
- Study completion
- 13 Jan 2025 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson Disease (PD) | – | Diagnostic Test: Neuropsychological tests in PD, Diagnostic Test: Self-report questionnaires in PD, Device: 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) | – | 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 parametersThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by Parkinson's Disease and Anorexia Nervosa
Key inclusion criteria (3 listed)
- Parkinson's Disease
- Anorexia nervosa
- Written informed consent
Key exclusion criteria (6 listed)
- Other psychiatric disorders
- Acute infectious diseases
- Chronic inflammatory diseases
- Other Disorders of central nervous system
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological tests in PDColored 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). | Diagnostic test | Parkinson Disease (PD) |
| Self-report questionnaires in PDSTAI 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). | Diagnostic test | Parkinson Disease (PD) |
| 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). | Device | Anorexia Nervosa (AN), Parkinson Disease (PD) |
| Neuropsychological tests in ANVerbal Fluencies, Tower of London, TMT-A \& B | Diagnostic test | Anorexia Nervosa (AN) |
| Self-report questionnaires in ANSTAI 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). | Diagnostic test | Anorexia Nervosa (AN) |
| Analysis of bio-humoral parametersthe 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 | Diagnostic test | Anorexia Nervosa (AN) |
Primary outcome
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)
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).
4 secondary outcomes
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Parkinson Disease, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Riccaro Cremascoli, MD, PhD (+393497292068, r.cremascoli@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.