Bulimia NervosaMetaBouNCT05879679
Pilot Study on the Validity of the Metacognitive Hub Model of Craving in Bulimia Nervosa (BN) and Binge Eating Disorders (BED)
An observational study of Bulimia Nervosa and Binge-Eating Disorder, run by Laval University at 3 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Bulimia Nervosa, Binge-Eating Disorder
- What is being tested?
- Food craving induction
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 8 Jan 2024to Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- have been medically diagnosed with binge eating disorder or bulimia nervosa
- fluent in french
- able to consent
Who cannot join
- co-morbid substance use disorder,
- pregnancy or breastfeeding
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites, 2 recruiting
- Not yet recruiting
Centre d'expertise Poids, Image et Alimentation (CEPIA)
Québec
Catherine Bégin, PhD
- Recruiting
IUCPQ
Québec
sylvain Iceta
France1 site, 1 recruiting
- Not yet recruiting
Université de Nantes
Nantes
Valentin Flaudias, Psy, PhD
Valentin Flaudias, Pdy, PhD
About this study
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.
Read more
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:
- the induction of food craving will affect the reflexive, automatic, and interoceptive systems of patients with bulimia nervosa and binge eating disorder.
- the magnitude of the effect of food craving induction on implicit craving and explicit craving will be modulated by the participants' metacognitive abilities.
- Conditions
- Bulimia Nervosa, Binge-Eating Disorder
- Being tested
- Food craving induction
- Keywords
- craving, addiction, metacognition, neurocognition
- Medical subject headings
- Bulimia Nervosa, Binge-Eating Disorder, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food craving inductionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Binge Eating Disorder | Participants with a binge eating disorder (DSM-5 criteria) Receives: Behavioral: Food craving induction | |
| Bulimia Nervosa | Participants with a bulimia nervosa (DSM-5 criteria) Receives: Behavioral: Food craving induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention Network Test (ANT)
The ANT is a task designed to test three attentional networks in children and adults: alerting, orienting, and executive control
Measured: 1 hour (after food craving induction)
Dot Probe Task
To test and measure selective attention
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 hour (after food craving induction)
Secondary outcomes (10)
Beck Depression Inventory II (BDI-II)
Minimum score : 0; Maximun score : 63; Higher scores mean a worse outcome.
Measured: 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.
Measured: 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.
Measured: Baseline
Food Craving Questionnaire State (FCQ-S)
Minimum : 15; Maximun : 75; Higher scores mean a worse outcome.
Measured: Baseline
Food Craving Questionnaire Trait (FCQ-T)
Minimum : 39; Maximun : 234; Higher scores mean a worse outcome.
Measured: 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.
Measured: 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.
Measured: Baseline
Difficulties in Emotional Regulation Scale (DERS- 18)
Minimum score : 18, maximun score : 90; Higher scores mean a worse outcome.
Measured: Baseline
Attentional Control Scale (ACS)
Minimum score : 20, maximun score : 80; Higher scores mean a better outcome.
Measured: Baseline
Body Awareness Questionnaire (BAQ)
Minimum score: 18; Maximun score: 126; Higher scores mean a better outcome.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start8 Jan 2024
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Sylvain Iceta, Laval University
- Investigators
- Sylvain Iceta, MD, PhD, Principal investigator, Fondation IUCPQValentin Flaudias, Psy, PhD, Study chair, Université de Nantes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879679
- Sponsor's protocol ID
- 2024-4019, 22336
- Acronym
- MetaBou
- Status last verified
- Jun 2024
- First submitted
- 10 May 2023
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Validity of the Metacognitive Hub Model of Craving in Bulimia Nervosa (BN) and Binge Eating Disorders (BED)
- ClinicalTrials.gov ID
- NCT05879679
- Acronym / sponsor ID
- MetaBou / 2024-4019, 22336
- Conditions
- Bulimia Nervosa, Binge-Eating Disorder
- Keywords
- craving, addiction, metacognition, neurocognition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- 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
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- the induction of food craving will affect the reflexive, automatic, and interoceptive systems of patients with bulimia nervosa and binge eating disorder.
- the magnitude of the effect of food craving induction on implicit craving and explicit craving will be modulated by the participants' metacognitive abilities.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Binge Eating Disorder | – | Behavioral: Food craving inductionParticipants with a binge eating disorder (DSM-5 criteria) |
| Bulimia Nervosa | – | Behavioral: Food craving inductionParticipants with a bulimia nervosa (DSM-5 criteria) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- have been medically diagnosed with binge eating disorder or bulimia nervosa
- fluent in french
- able to consent
Key exclusion criteria (2 listed)
- co-morbid substance use disorder,
- pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food craving inductionStandardized 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. | Behavioural | Binge Eating Disorder, Bulimia Nervosa |
Primary outcome
Attention Network Test (ANT)
Time frame: 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
Dot Probe Task
Time frame: 1 hour (after food craving induction)
To test and measure selective attention
Water load task
Time frame: 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.
Live metacognition
Time frame: 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.
Avoidance/Approach task adapted for food craving
Time frame: 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.
10 secondary outcomes
Beck Depression Inventory II (BDI-II)
Time frame: Baseline
State-Trait Anxiety Inventory (STAI)
Time frame: Baseline
Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: Baseline
Food Craving Questionnaire State (FCQ-S)
Time frame: Baseline
Food Craving Questionnaire Trait (FCQ-T)
Time frame: Baseline
Visual Analogic Scale of craving
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)
Time frame: Baseline
Difficulties in Emotional Regulation Scale (DERS- 18)
Time frame: Baseline
Attentional Control Scale (ACS)
Time frame: Baseline
Body Awareness Questionnaire (BAQ)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvain Iceta, MD, PhD principal investigator
Fondation IUCPQ
Valentin Flaudias, Psy, PhD study chair
Université de Nantes
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bulimia Nervosa and Binge-Eating Disorder, run by Laval University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabrielle Hudon, Msc (+14186568711 ext. 8015, equipe.iceta@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention Network Test (ANT) (time frame: 1 hour (after food craving induction)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.