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

Bulimia Nervosa Clinical Trial

— MetaBou  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05879679
• Other study ID #: 2024-4019, 22336
• Status: Recruiting
• Start date: January 8, 2024
• Est. completion date: October 2025

Study information

• Verified date: June 2024
• Source: Laval University
• Contact: Gabrielle Hudon, Msc
• Phone: +14186568711
• Email: equipe.iceta[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Feeding and Eating Disorders

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre d'expertise Poids, Image et Alimentation (CEPIA)	Québec
Canada	IUCPQ	Québec
France	Université de Nantes	Nantes

Sponsors (4)

Lead Sponsor	Collaborator
Laval University	Centre d'expertise Poids, Image et Alimentation (CEPIA), Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Université de Nantes

Countries where clinical trial is conducted

Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age		Baseline
Other	Gender		Baseline
Other	Biological sex		Baseline
Other	Weight		Baseline
Other	Height		Baseline
Other	Body Mass Index (BMI)	Weight / Height2	Baseline
Other	Waist and hips circumferences	in cm	Baseline
Other	Menopausal status or contraception		Baseline
Other	Socio-professional category	Number of participants per socioprofessional category as defined by statistic canada	Baseline
Other	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
Other	Ethnic origin		Baseline
Primary	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)
Primary	Dot Probe Task	To test and measure selective attention	1 hour (after food craving induction)
Primary	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)
Primary	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)
Primary	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	Beck Depression Inventory II (BDI-II)	Minimum score : 0; Maximun score : 63; Higher scores mean a worse outcome.	Baseline
Secondary	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
Secondary	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
Secondary	Food Craving Questionnaire State (FCQ-S)	Minimum : 15; Maximun : 75; Higher scores mean a worse outcome.	Baseline
Secondary	Food Craving Questionnaire Trait (FCQ-T)	Minimum : 39; Maximun : 234; Higher scores mean a worse outcome.	Baseline
Secondary	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_
Secondary	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
Secondary	Difficulties in Emotional Regulation Scale (DERS- 18)	Minimum score : 18, maximun score : 90; Higher scores mean a worse outcome.	Baseline
Secondary	Attentional Control Scale (ACS)	Minimum score : 20, maximun score : 80; Higher scores mean a better outcome.	Baseline
Secondary	Body Awareness Questionnaire (BAQ)	Minimum score: 18; Maximun score: 126; Higher scores mean a better outcome.	Baseline