An observational study in Bulimia Nervosa and Binge-Eating Disorder, sponsored by Laval University. Recruiting at 3 sites in 2 countries. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-06-20.
Sponsored by Laval University · Observational
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:
173 studies on the registry are indexed under Bulimia Nervosa; 39 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 47 observational studies indexed under Bulimia Nervosa.
Browse Bulimia Nervosa studies →Laval University is the lead sponsor of 380 studies on the registry; 67 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants with a binge eating disorder (DSM-5 criteria)
Behavioral: Food craving induction
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.
Attention Network Test (ANT)
The ANT is a task designed to test three attentional networks in children and adults: alerting, orienting, and executive control
Time frame: 1 hour (after food craving induction)
Dot Probe Task
To test and measure selective attention
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 hour (after food craving induction)
Beck Depression Inventory II (BDI-II)
Minimum score : 0; Maximun score : 63; Higher scores mean a worse outcome.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Food Craving Questionnaire State (FCQ-S)
Minimum : 15; Maximun : 75; Higher scores mean a worse outcome.
Time frame: Baseline
Food Craving Questionnaire Trait (FCQ-T)
Minimum : 39; Maximun : 234; Higher scores mean a worse outcome.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Difficulties in Emotional Regulation Scale (DERS- 18)
Minimum score : 18, maximun score : 90; Higher scores mean a worse outcome.
Time frame: Baseline
Attentional Control Scale (ACS)
Minimum score : 20, maximun score : 80; Higher scores mean a better outcome.
Time frame: Baseline
Body Awareness Questionnaire (BAQ)
Minimum score: 18; Maximun score: 126; Higher scores mean a better outcome.
Time frame: Baseline
Age
Time frame: Baseline
Gender
Time frame: Baseline
Biological sex
Time frame: Baseline
Weight
Time frame: Baseline
Height
Time frame: Baseline
Body Mass Index (BMI)
Weight / Height2
Time frame: Baseline
Waist and hips circumferences
in cm
Time frame: Baseline
Menopausal status or contraception
Time frame: Baseline
Socio-professional category
Number of participants per socioprofessional category as defined by statistic canada
Time frame: 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.
Time frame: Baseline
Ethnic origin
Time frame: Baseline
Plan to share: Undecided
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