Clinical trial NCT05879679: Pilot Study on the Validity of the Metacognitive Hub Model of Craving in Bulimia Nervosa (BN) and Binge Eating Disorders (BED)
Official title: Pilot Study on the Validity of the Metacognitive Hub Model of Craving in Bulimia Nervosa (BN) and Binge Eating Disorders (BED)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bulimia Nervosa
Binge-Eating Disorder
Keywords: craving
addiction
metacognition
neurocognition
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Université de Nantes
name: Centre d'expertise Poids, Image et Alimentation (CEPIA)
name: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
First posted: 2023-05-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Attention Network Test (ANT)
timeFrame: 1 hour (after food craving induction)
measure: Dot Probe Task
timeFrame: 1 hour (after food craving induction)
measure: Water load task
timeFrame: 1 hour (after food craving induction)
measure: Live metacognition
timeFrame: 1 hour (after food craving induction)
measure: Avoidance/Approach task adapted for food craving
timeFrame: 1 hour (after food craving induction)
Secondary outcomes:
measure: Beck Depression Inventory II (BDI-II)
timeFrame: Baseline
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline
measure: Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: Baseline
measure: Food Craving Questionnaire State (FCQ-S)
timeFrame: Baseline
measure: Food Craving Questionnaire Trait (FCQ-T)
timeFrame: Baseline
measure: Visual Analogic Scale of craving
timeFrame: Baseline, at 1 hour (after craving induction), at 3 hours (end of the session_
measure: Schedule for the Assessment of Insight in Eating Disorders (SAI-ED)
timeFrame: Baseline
measure: Difficulties in Emotional Regulation Scale (DERS- 18)
timeFrame: Baseline
measure: Attentional Control Scale (ACS)
timeFrame: Baseline
measure: Body Awareness Questionnaire (BAQ)
timeFrame: Baseline
Other outcomes:
measure: Age
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Biological sex
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Waist and hips circumferences
timeFrame: Baseline
measure: Menopausal status or contraception
timeFrame: Baseline
measure: Socio-professional category
timeFrame: Baseline
measure: Medical history and concomitant treatment
timeFrame: Baseline
measure: Ethnic origin
timeFrame: Baseline
Locations:
city: Québec
country: Canada
facility: Centre d'expertise Poids, Image et Alimentation (CEPIA)
city: Québec
country: Canada
facility: IUCPQ
city: Nantes
country: France
facility: Université de Nantes
Study officials:
affiliation: Fondation IUCPQ
name: Sylvain Iceta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Nantes
name: Valentin Flaudias, Psy, PhD
role: STUDY_CHAIR
References: