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

Sponsor
Laval University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05879679
Collaborator
Université de Nantes (Other), Centre d'expertise Poids, Image et Alimentation (CEPIA) (Other), Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Other)
60
2
25
30
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Food craving induction

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Pilot Study on the Validity of the Metacognitive Hub Model of Craving in Bulimia Nervosa (BN) and Binge Eating Disorders (BED)
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Dot Probe Task [1 hour (after food craving induction)]

    To test and measure selective attention

  3. Water load task [1 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.

  4. Live metacognition [1 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.

  5. Avoidance/Approach task adapted for food craving [1 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.

Secondary Outcome Measures

  1. Beck Depression Inventory II (BDI-II) [Baseline]

    Minimum score : 0; Maximun score : 63; Higher scores mean a worse outcome.

  2. State-Trait Anxiety Inventory (STAI) [Baseline]

    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.

  3. Eating Disorder Examination Questionnaire (EDE-Q) [Baseline]

    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.

  4. Food Craving Questionnaire State (FCQ-S) [Baseline]

    Minimum : 15; Maximun : 75; Higher scores mean a worse outcome.

  5. Food Craving Questionnaire Trait (FCQ-T) [Baseline]

    Minimum : 39; Maximun : 234; Higher scores mean a worse outcome.

  6. Visual Analogic Scale of craving [Baseline, 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.

  7. Schedule for the Assessment of Insight in Eating Disorders (SAI-ED) [Baseline]

    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.

  8. Difficulties in Emotional Regulation Scale (DERS- 18) [Baseline]

    Minimum score : 18, maximun score : 90; Higher scores mean a worse outcome.

  9. Attentional Control Scale (ACS) [Baseline]

    Minimum score : 20, maximun score : 80; Higher scores mean a better outcome.

  10. Body Awareness Questionnaire (BAQ) [Baseline]

    Minimum score: 18; Maximun score: 126; Higher scores mean a better outcome.

Other Outcome Measures

  1. Age [Baseline]

  2. Gender [Baseline]

  3. Biological sex [Baseline]

  4. Weight [Baseline]

  5. Height [Baseline]

  6. Body Mass Index (BMI) [Baseline]

    Weight / Height2

  7. Waist and hips circumferences [Baseline]

    in cm

  8. Menopausal status or contraception [Baseline]

  9. Socio-professional category [Baseline]

    Number of participants per socioprofessional category as defined by statistic canada

  10. Medical history and concomitant treatment [Baseline]

    Rates of various associated diseases (e.g., cardiovascular, digestive disorders). Type of medications (antidepressants, antipsychotics, hypotensive drugs) and their rates.

  11. Ethnic origin [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre d'expertise Poids, Image et Alimentation (CEPIA) Québec Canada
2 IUCPQ Québec Canada

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Sylvain Iceta, MD, PhD, Fondation IUCPQ

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sylvain Iceta, Associate professor, Laval University
ClinicalTrials.gov Identifier:
NCT05879679
Other Study ID Numbers:
  • 2024-4019, 22336
First Posted:
May 30, 2023
Last Update Posted:
May 30, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sylvain Iceta, Associate professor, Laval University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 30, 2023