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

June 17, 2024 updated by: Sylvain Iceta, Laval University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
      • Québec, Canada
        • Not yet recruiting
        • Centre d'expertise Poids, Image et Alimentation (CEPIA)
        • Contact:
          • Catherine Bégin, PhD
      • Québec, Canada
        • Recruiting
        • IUCPQ
        • Contact:
          • sylvain Iceta
  • France
      • Nantes, France
        • Not yet recruiting
        • Université de Nantes
        • Contact:
          • Valentin Flaudias, Psy, PhD
        • Principal Investigator:
          • Valentin Flaudias, Pdy, PhD
        • Sub-Investigator:
          • Aurelien Cornil, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 hour (after food craving induction)
Dot Probe Task
Time Frame: 1 hour (after food craving induction)
To test and measure selective attention
1 hour (after food craving induction)
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.
1 hour (after food craving induction)
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.
1 hour (after food craving induction)
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.
1 hour (after food craving induction)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory II (BDI-II)
Time Frame: Baseline
Minimum score : 0; Maximun score : 63; Higher scores mean a worse outcome.
Baseline
State-Trait Anxiety Inventory (STAI)
Time Frame: 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.
Baseline
Eating Disorder Examination Questionnaire (EDE-Q)
Time Frame: 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.
Baseline
Food Craving Questionnaire State (FCQ-S)
Time Frame: Baseline
Minimum : 15; Maximun : 75; Higher scores mean a worse outcome.
Baseline
Food Craving Questionnaire Trait (FCQ-T)
Time Frame: Baseline
Minimum : 39; Maximun : 234; Higher scores mean a worse outcome.
Baseline
Visual Analogic Scale of craving
Time Frame: 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.
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
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.
Baseline
Difficulties in Emotional Regulation Scale (DERS- 18)
Time Frame: Baseline
Minimum score : 18, maximun score : 90; Higher scores mean a worse outcome.
Baseline
Attentional Control Scale (ACS)
Time Frame: Baseline
Minimum score : 20, maximun score : 80; Higher scores mean a better outcome.
Baseline
Body Awareness Questionnaire (BAQ)
Time Frame: Baseline
Minimum score: 18; Maximun score: 126; Higher scores mean a better outcome.
Baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Height
Time Frame: Baseline
Baseline
Weight
Time Frame: Baseline
Baseline
Gender
Time Frame: Baseline
Baseline
Age
Time Frame: Baseline
Baseline
Biological sex
Time Frame: Baseline
Baseline
Body Mass Index (BMI)
Time Frame: Baseline
Weight / Height2
Baseline
Waist and hips circumferences
Time Frame: Baseline
in cm
Baseline
Menopausal status or contraception
Time Frame: Baseline
Baseline
Socio-professional category
Time Frame: Baseline
Number of participants per socioprofessional category as defined by statistic canada
Baseline
Medical history and concomitant treatment
Time Frame: Baseline
Rates of various associated diseases (e.g., cardiovascular, digestive disorders). Type of medications (antidepressants, antipsychotics, hypotensive drugs) and their rates.
Baseline
Ethnic origin
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Université de Nantes
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Centre d'expertise Poids, Image et Alimentation (CEPIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sylvain Iceta, MD, PhD, Fondation IUCPQ
  • Study Chair: Valentin Flaudias, Psy, PhD, Université de Nantes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-4019, 22336

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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