Pilot Study on the Validity of the Metacognitive Hub Model of Craving in Bulimia Nervosa (BN) and Binge Eating Disorders (BED)

NCT05879679 | Recruiting

• 1 other identifier: 2024-4019, 22336
• Study Type: observational
• Target: 60
• Locations: 2 countries
• Sites: 3

Brief Summary

Craving is defined as an irrepressible urge to consume certain products and represents one of the key factors in severe substance use disorders, as illustrated by its recent inclusion as a diagnostic criterion in the most recent fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM 5). However, the pathophysiological models of craving remain debated. The "metacognitive hub model", a conceptual, experimental and clinical approach to craving, proposes that craving should be considered as the embedded consequence of the interaction between three components (the reflexive, automatic and interoceptive systems), each of which has an implicit and explicit element. This model links the three components by suggesting that metacognitive abilities, the ability to understand one's own cognitive functioning, may be a skill of individuals that allows them to make the three sub-components explicit or not. To date, the conception of eating disorders is increasingly similar to that of addictive disorders. Indeed, there is growing evidence that the symptomatology of bulimia nervosa and binge eating disorder can be considered in part as an "food addiction" and would fit the diagnostic criteria of an addictive disorder. Bulimia nervosa is an eating disorder (DSM 5) characterized by a cycle of binge eating and compensatory behaviors such as self-induced vomiting that tend to negate or compensate for the effects of the binge eating. Binge eating disorder (DSM 5) is characterized by a cycle of binge eating, but without the compensatory behaviors seen in bulimia nervosa. In addition, there are common neurological aspects as well as similar cognitions between these eating disorders and addictive disorders. Given the importance of craving in addictive pathology, it seems essential to address this issue in bulimia nervosa and binge eating disorder. The cognitive difficulties of patients with bulimia nervosa and binge eating disorder, which are close to the difficulties observed in patients with addictive behaviors, suggest that the "metacognitive hub model" could provide a clear and measurable theoretical framework of the different dimensions of craving. The overall objective of this project is to explore the relationship between the level of craving induced by food picture exposure and the level of impairment of the reflexive, automatic, interoceptive, and metacognitive systems in women with bulimia nervosa and binge eating disorder and to compare these impairments according to the nature of the eating disorder (i.e., binge eating versus bulimia nervosa). Our hypotheses are:

1. 1.the induction of food craving will affect the reflexive, automatic, and interoceptive systems of patients with bulimia nervosa and binge eating disorder.
2. 2.the magnitude of the effect of food craving induction on implicit craving and explicit craving will be modulated by the participants' metacognitive abilities.

Conditions

Bulimia Nervosa; Binge-Eating Disorder

Keywords

craving; addiction; metacognition; neurocognition

Outcome Measures

Primary Outcomes (5)

• Attention Network Test (ANT)

  The ANT is a task designed to test three attentional networks in children and adults: alerting, orienting, and executive control

  1 hour (after food craving induction)

• Dot Probe Task

  To test and measure selective attention

  1 hour (after food craving induction)

• Water load task

  This task was originally developed to induce gastric distension and assess gastrointestinal symptoms in patients with functional digestive disorders. This task stimulates the stomach using a natural distension stimulus (i.e., water ingestion) and without the complex hormonal response of a caloric meal.

  1 hour (after food craving induction)

• Live metacognition

  "live" metacognitive assessment will be done by asking the participants to rate their level of confidence on a visual analog scale ranging from 0% (I just guessed) to 100% (completely confident) for each items.

  1 hour (after food craving induction)

• Avoidance/Approach task adapted for food craving

  In this task, participants are asked to move a joystick that simulates the movement of the food represented in the image. The joystick movements are accompanied by a zoom effect that increases the illusion of movement.

  1 hour (after food craving induction)

Secondary Outcomes (10)

• Beck Depression Inventory II (BDI-II)

  Baseline

• State-Trait Anxiety Inventory (STAI)

  Baseline

• Eating Disorder Examination Questionnaire (EDE-Q)

  Baseline

• Food Craving Questionnaire State (FCQ-S)

  Baseline

• Food Craving Questionnaire Trait (FCQ-T)

  Baseline

Other Outcomes (11)

• Age

  Baseline

• Gender

  Baseline

• Biological sex

  Baseline

Study Arms (2)

Binge Eating Disorder

Participants with a binge eating disorder (DSM-5 criteria)

Behavioral: Food craving induction

Bulimia Nervosa

Participants with a bulimia nervosa (DSM-5 criteria)

Behavioral: Food craving induction

Interventions

Food craving induction BEHAVIORAL

Standardized craving induction procedure will be used, based on exposure to food-related images (https://www.lippc2s.fr/food-cal-pictures/). Craving intensity will be measured by visual analogic scale before and after the induction sequence.

Binge Eating Disorder; Bulimia Nervosa

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants consulted by specialized psychiatrist at IUCPQ Participants who have already participated in a research project and have agreed to be contacted for other projects Participants recruited via the ANEB and Maison l'Éclaircie mailing lists and via an ad on social networks. Participants receiving care at the CEPIA or on the CEPIA waiting list.

You may qualify if:

• have been medically diagnosed with binge eating disorder or bulimia nervosa
• fluent in french
• able to consent

You may not qualify if:

• co-morbid substance use disorder,
• pregnancy or breastfeeding

Sponsors & Collaborators

• Laval University: lead
• Université de Nantes: collaborator
• Centre d'expertise Poids, Image et Alimentation (CEPIA): collaborator
• Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec: collaborator

Study Sites (3)

Centre d'expertise Poids, Image et Alimentation (CEPIA)

Québec, Canada

NOT YET RECRUITING

IUCPQ

Québec, Canada

RECRUITING

Université de Nantes

Nantes, France

NOT YET RECRUITING

MeSH Terms

Conditions

Bulimia Nervosa; Binge-Eating Disorder; Behavior, Addictive

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Sylvain Iceta, MD, PhD

  Fondation IUCPQ

  PRINCIPAL INVESTIGATOR

• Valentin Flaudias, Psy, PhD

  Université de Nantes

  STUDY CHAIR

Central Study Contacts

Gabrielle Hudon, Msc

CONTACT

+14186568711; equipe.iceta@criucpq.ulaval.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 30, 2023
• Study Start: January 8, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

CA (2); FR (1)