Cognitive Evaluation of Patients With Eating Disorders

NCT07478510 | Recruiting

• 1 other identifier: 0025652/24
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 3

Brief Summary

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;

Conditions

ARFID; Anorexia Nervosa; Bulimia Nervosa; Cognitive Flexibility; Executive Functions; Implicit Association Test

Outcome Measures

Primary Outcomes (2)

• What is the cognitive profile of patients with ARFID, with particular reference to autistic traits and cognitive flexibility?

  The Autism Spectrum Quotient (AQ) questionnarie has the purpose to evaluate the levels of autistic traits in each participant and permit to understand the differences between the groups. The scoring of this questionnaire stays in the range 0-50, where 0 is the minimum and associated with less autistic traits and 50 is the maximum outcome possible, explaining elevated autistic traits. Usually, the cut-off is defined as 32, over that score is possible to define the presence of autistic traits.

  Baseline

• What is the cognitive profile of patients with ARFID, with particular reference to autistic traits and cognitive flexibility?

  The higher the percentage of perseverative errors out of the total errors made on the Wisconsin Card Sorting Test (WCST), the lower the subject's cognitive flexibility. The WCST assesses executive functions, particularly cognitive flexibility, set-shifting ability, and problem-solving strategies. Scoring is typically based on several indices, including number of categories completed, total errors, and perseverative errors, with perseverative errors often expressed as a percentage of total responses. There is no universally accepted clinical cut-off for WCST performance, as interpretation is usually based on comparison with age-adjusted normative data; however, higher percentages of perseverative errors are generally interpreted as indicating greater executive dysfunction. The scale starts at 0%, which indicates full cognitive flexibility, and increases accordingly torwards 100%, indicating cognitive rigidity.

  Baseline

Secondary Outcomes (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?

  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?

  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?

  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?

  Baseline

Study Arms (3)

Healthy control

Every participant recieve all the interventions described, each one of them with the specific randomization of subministration.

Behavioral: Go/No-go; Behavioral: IAT; Behavioral: WCST

ARFID

Patients with Avoidant Restrictive Food Intake Disorder. Every participant recieve all the interventions described, each one of them with the specific randomization of subministration.

Behavioral: Go/No-go; Behavioral: IAT; Behavioral: WCST

AN/BN

Patients with a diagnosis of Anorexia Nervosa or Bulimia Nervosa. Every participant recieve all the interventions described, each one of them with the specific randomization of subministration.

Behavioral: Go/No-go; Behavioral: IAT; Behavioral: WCST

Interventions

Go/No-go BEHAVIORAL

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.

AN/BN; ARFID; Healthy control

IAT BEHAVIORAL

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.

AN/BN; ARFID; Healthy control

WCST BEHAVIORAL

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 "right" or "wrong," forcing the participant to deduce the rule (color, shape, or number). The rule changes unexpectedly after a certain number of correct matches. It provides scores for categories completed, trials, total errors, and, critically, perseverative errors (continuing to use a previous, invalid rule). The investigators used the 128 cards version.

AN/BN; ARFID; Healthy control

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adolescent and adult participants aged between 14 and 65 years, of both sexes, recruited among individuals diagnosed with Feeding and Eating Disorders and healthy control volunteers. The clinical group consists of patients with a diagnosis of Avoidant/Restrictive Food Intake Disorder, anorexia nervosa, or bulimia nervosa, with a Body Mass Index (BMI) lower than 25. Eligible participants must meet the diagnostic criteria for a Feeding and Eating Disorder according to DSM-5-TR and must provide written informed consent to participate in the study. For participants under the age of 18, written consent from parents or legal guardians is required in addition to the minor's assent. A group of healthy control participants will be recruited in order to obtain a sample balanced with the patient group in terms of sex, age, and educational level. The same inclusion and exclusion criteria applied to the patient group will be considered for the control group.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Istituto Psicologico Italiano s.r.l.s.: collaborator
• ASST Fatebenefratelli Sacco: collaborator

Study Sites (3)

IUSS Pavia - Istituto Universitario di Studi Superiori

Pavia, PV, 27100, Italy

RECRUITING

Istituto Psicologico Italiano s.r.l.s.

Milan, 20124, Italy

RECRUITING

ASST Fatebenefratelli Sacco

Milan, 20157, Italy

RECRUITING

MeSH Terms

Conditions

Avoidant Restrictive Food Intake Disorder; Anorexia Nervosa; Bulimia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Central Study Contacts

Giulia Mattavelli, Associated prof., researcher

CONTACT

+39 3397893500; giulia.mattavelli@iusspavia.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: March 17, 2026
• Study Start: November 26, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)