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

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

Study Overview

• Status: Recruiting
• Conditions: Binge-Eating Disorder; Bulimia Nervosa
• Intervention / Treatment: Behavioral: Food craving induction

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Gabrielle Hudon, Msc; Phone Number: 8015 +14186568711; Email: equipe.iceta@criucpq.ulaval.ca

Study Locations

• Canada
  • Québec, Canada
    • Not yet recruiting
    • Centre d'expertise Poids, Image et Alimentation (CEPIA)
    • Contact: Catherine Bégin, PhD
  • Québec, Canada
    • Recruiting
    • IUCPQ
    • Contact: sylvain Iceta
• France
  • Nantes, France
    • Not yet recruiting
    • Université de Nantes
    • Contact: Valentin Flaudias, Psy, PhD
    • Principal Investigator: Valentin Flaudias, Pdy, PhD
    • Sub-Investigator: Aurelien Cornil, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Binge Eating Disorder; Participants with a binge eating disorder (DSM-5 criteria)	Behavioral: Food craving induction; 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.
Bulimia Nervosa; Participants with a bulimia nervosa (DSM-5 criteria)	Behavioral: Food craving induction; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory II (BDI-II)	Minimum score : 0; Maximun score : 63; Higher scores mean a worse outcome.	Baseline
State-Trait Anxiety Inventory (STAI)	The questionnaire includes two scales (20 items) consisting of a total of 40 questions. For each scale the minimum score is 0 and the maximun score is 80. Higher scores mean a worse outcome.	Baseline
Eating Disorder Examination Questionnaire (EDE-Q)	The measure provides four attitudinal subscale scores: Restraint (5 items), Eating Concern (5 items), Shape Concern (8 items), and Weight Concern (5 items). An overall Global score is the mean of the four subscale scores. Responses are on a 7-point ordinal response; minimum score : 0, maximun score: 6; higher scores mean a worse outcome.	Baseline
Food Craving Questionnaire State (FCQ-S)	Minimum : 15; Maximun : 75; Higher scores mean a worse outcome.	Baseline
Food Craving Questionnaire Trait (FCQ-T)	Minimum : 39; Maximun : 234; Higher scores mean a worse outcome.	Baseline
Visual Analogic Scale of craving	It represents a continuous visual progression of craving from one extreme to another, from "no craving at all" to "extreme and uncontrollable craving," with patients stating the intensity of their current craving between these two extremes.	Baseline, at 1 hour (after craving induction), at 3 hours (end of the session_
Schedule for the Assessment of Insight in Eating Disorders (SAI-ED)	Interview-based scale for the multidimensional assessment of insight in eating disorders. It includes three categories: illness awareness, symptom awareness, and treatment engagement. Minimum score : 0, maximun score: 29; Higher scores mean a better outcome.	Baseline
Difficulties in Emotional Regulation Scale (DERS- 18)	Minimum score : 18, maximun score : 90; Higher scores mean a worse outcome.	Baseline
Attentional Control Scale (ACS)	Minimum score : 20, maximun score : 80; Higher scores mean a better outcome.	Baseline
Body Awareness Questionnaire (BAQ)	Minimum score: 18; Maximun score: 126; Higher scores mean a better outcome.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height		Baseline
Weight		Baseline
Gender		Baseline
Age		Baseline
Biological sex		Baseline
Body Mass Index (BMI)	Weight / Height2	Baseline
Waist and hips circumferences	in cm	Baseline
Menopausal status or contraception		Baseline
Socio-professional category	Number of participants per socioprofessional category as defined by statistic canada	Baseline
Medical history and concomitant treatment	Rates of various associated diseases (e.g., cardiovascular, digestive disorders). Type of medications (antidepressants, antipsychotics, hypotensive drugs) and their rates.	Baseline
Ethnic origin		Baseline

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Université de Nantes; Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec; Centre d'expertise Poids, Image et Alimentation (CEPIA)
• Investigators: Principal Investigator: Sylvain Iceta, MD, PhD, Fondation IUCPQ; Study Chair: Valentin Flaudias, Psy, PhD, Université de Nantes

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: craving; addiction; metacognition; neurocognition
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa
• Other Study ID Numbers: 2024-4019, 22336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No