Cognitive Evaluation of Patients With Eating Disorders

Official title

Neuro-cognitive Profiles of Patients With Nutritional and Eating Disorders

Overview

The goal of this cross - sectional observational study is to improve understanding of the psychological and cognitive characteristics of Feeding and Eating Disorders (FEDs), a group of conditions that represent a growing public health concern due to their significant impact on physical health, emotional well-being, and everyday functioning. Within this broader diagnostic category, particular attention is given to Avoidant/Restrictive Food Intake Disorder (ARFID), a diagnosis introduced in the DSM-5 and still relatively underexplored compared to other feeding and eating disorders. Despite its clinical relevance, ARFID remains less well understood in terms of its underlying cognitive and psychological mechanisms. Individuals with ARFID often experience severe food avoidance or restriction that is not driven by weight or shape concerns, but rather by sensory sensitivities, fear of negative consequences of eating, or a lack of interest in food. For this reason, investigating ARFID can offer important insights into the diversity of mechanisms involved in feeding and eating disorders as a whole. The study has two main objectives. The first objective is to examine the cognitive profile of individuals with ARFID, with a specific focus on autistic traits and cognitive flexibility, as previous research suggests potential overlaps between ARFID and neurodevelopmental conditions such as Autism Spectrum Disorders. Cognitive flexibility refers to the ability to adapt thoughts and behaviors in response to changing situations, and reduced flexibility may contribute to rigid eating patterns and food avoidance. The second objective is to explore the role of body representation (how individuals perceive and mentally represent their own body) and inhibitory control (the ability to regulate or suppress automatic responses) in shaping the cognitive and behavioral features of ARFID and other feeding and eating disorders. These processes may help distinguish ARFID from other diagnoses and clarify shared and disorder-specific mechanisms across the FED spectrum. The study involves adult participants of all genders, including individuals diagnosed with ARFID, anorexia nervosa, and bulimia nervosa, as well as healthy control participants without a history of feeding or eating disorders. This design allows meaningful comparisons between different diagnostic groups and with the general population. The main questions the study aims to answer are: Do individuals with ARFID show a distinct cognitive profile, particularly in terms of autistic traits and cognitive flexibility, compared to individuals with other feeding and eating disorders and healthy controls? How do body representation and inhibitory control contribute to differences in eating-related behaviors across feeding and eating disorders? Are there differences in brain activity associated with implicit, automatic attitudes toward food in individuals with feeding and eating disorders compared to healthy individuals? Where comparison groups are included, researchers will compare participants with ARFID, anorexia nervosa, bulimia nervosa, and healthy controls to examine differences in cognitive functioning, psychological characteristics, and neural responses related to food processing. Participants will be asked to take part in a series of non-invasive and well-established research activities, designed to be accessible and safe. These include: Completing self-report questionnaires assessing autistic traits, body image perception, and general psychological well-being; Performing computer-based tasks that assess cognitive flexibility and decision-making; Completing behavioral tasks designed to measure inhibitory control and automatic associations with food-related stimuli;

Interventions

• Behavioral Go/No-go
  The investigators designed a specific task, base in literature, to evaluate the inibithory response to food stimuli of different types (high calories, low calories, neutral stimuli). The images have been defined by a pilot selection and added to the task designed on Psychopy.
• Behavioral IAT
  The investigators designed a specific task, base in literature, to evaluate the implicit association of body images (overweight, underweight, normalweight) and word to different lables. The body images have been defined by a pilot selection and added to the task designed on Psychopy.
• Behavioral WCST
  The Wisconsin Card Sorting Test (WCST) is a neuropsychological assessment of executive function, cognitive flexibility, and abstract reasoning. Participants match stimulus cards based on color, form, or number, adapting to changing, unstated rules based on examiner feedback. It measures the ability to display flexibility in the face of changing schedules of reinforcement, specifically "set-shifting". A participant is given a deck of cards and told to match them, but not how. The examiner says "r

Primary outcome measures

• What is the cognitive profile of patients with ARFID, with particular reference to autistic traits and cognitive flexibility? [Time frame: Baseline]
• What is the cognitive profile of patients with ARFID, with particular reference to autistic traits and cognitive flexibility? [Time frame: Baseline]

Secondary outcome measures (4)

• What is the role of body representation and inhibitory control capacity in the differential diagnosis between ARFID and other eating disorders, such as Anorexia Nervosa and Bulimia Nervosa? [Time frame: Baseline]
• What is the role of body representation and inhibitory control capacity in the differential diagnosis between ARFID and other eating disorders, such as Anorexia Nervosa and Bulimia Nervosa? [Time frame: Baseline]
• What is the role of body representation and inhibitory control capacity in the differential diagnosis between ARFID and other eating disorders, such as Anorexia Nervosa and Bulimia Nervosa? [Time frame: Baseline]
• What is the role of body representation and inhibitory control capacity in the differential diagnosis between ARFID and other eating disorders, such as Anorexia Nervosa and Bulimia Nervosa? [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

• Diagnosis of a Feeding and Eating Disorder (ARFID, anorexia nervosa, or bulimia nervosa);
• Patients of both sexes;
• Age between 14 and 65 years;
• Confirmed diagnosis of a Feeding and Eating Disorder;
• Body Mass Index (BMI) < 25;
• Signed informed consent form for participation in the study.

Exclusion criteria

• Diagnosis of Bipolar Disorder according to DSM-5-TR criteria;
• Diagnosis of a Schizophrenia Spectrum Disorder according to DSM-5-TR criteria;
• Intellectual disability according to DSM-5-TR criteria;
• Presence of brain tumors;
• History of seizure events;
• Presence of other moderate to severe neurological disorders;
• Lack of the patient's consent to voluntary participation in the study;
• Lack of parental or legal guardian consent for participation of a minor in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Other

Study locations

Italy · 3 centers

• IUSS Pavia - Istituto Universitario di Studi Superiori — Pavia
• Istituto Psicologico Italiano s.r.l.s. — Milan
• ASST Fatebenefratelli Sacco — Milan

Identifiers

NCT: NCT07478510 · 0025652/24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗