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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05879679
Acronym
MetaBou
Enrollment
60
Registered
2023-05-30
Start date
2024-01-08
Completion date
2025-10-31
Last updated
2024-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge-Eating Disorder, Bulimia Nervosa

Keywords

craving, addiction, metacognition, neurocognition

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. 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.

Interventions

BEHAVIORALFood 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.

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Attention Network Test (ANT)1 hour (after food craving induction)The ANT is a task designed to test three attentional networks in children and adults: alerting, orienting, and executive control
Avoidance/Approach task adapted for food craving1 hour (after food craving induction)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.
Live metacognition1 hour (after food craving induction)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.
Water load task1 hour (after food craving induction)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.
Dot Probe Task1 hour (after food craving induction)To test and measure selective attention

Secondary

MeasureTime frameDescription
Eating Disorder Examination Questionnaire (EDE-Q)BaselineThe 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.
Beck Depression Inventory II (BDI-II)BaselineMinimum score : 0; Maximun score : 63; Higher scores mean a worse outcome.
State-Trait Anxiety Inventory (STAI)BaselineThe 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.
Food Craving Questionnaire State (FCQ-S)BaselineMinimum : 15; Maximun : 75; Higher scores mean a worse outcome.
Food Craving Questionnaire Trait (FCQ-T)BaselineMinimum : 39; Maximun : 234; Higher scores mean a worse outcome.
Visual Analogic Scale of cravingBaseline, at 1 hour (after craving induction), at 3 hours (end of the session_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.
Schedule for the Assessment of Insight in Eating Disorders (SAI-ED)BaselineInterview-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.
Difficulties in Emotional Regulation Scale (DERS- 18)BaselineMinimum score : 18, maximun score : 90; Higher scores mean a worse outcome.
Attentional Control Scale (ACS)BaselineMinimum score : 20, maximun score : 80; Higher scores mean a better outcome.
Body Awareness Questionnaire (BAQ)BaselineMinimum score: 18; Maximun score: 126; Higher scores mean a better outcome.

Other

MeasureTime frameDescription
GenderBaseline
Body Mass Index (BMI)BaselineWeight / Height2
Waist and hips circumferencesBaselinein cm
Menopausal status or contraceptionBaseline
Socio-professional categoryBaselineNumber of participants per socioprofessional category as defined by statistic canada
Medical history and concomitant treatmentBaselineRates of various associated diseases (e.g., cardiovascular, digestive disorders). Type of medications (antidepressants, antipsychotics, hypotensive drugs) and their rates.
Ethnic originBaseline
HeightBaseline
WeightBaseline
AgeBaseline
Biological sexBaseline

Countries

Canada, France

Contacts

Primary ContactGabrielle Hudon, Msc
equipe.iceta@criucpq.ulaval.ca+14186568711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026