- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03850288
Inhibitory Control and Eating Disorders (InhibEating)
Inhibitory Control in Eating Disorders (Anorexia Nervosa, Bulimia Nervosa and Binge Eating Disorder)
Executive functions are part of the high-level cognitive processes essential to the proper functioning of human cognition. They consist mainly of flexibility, updating and inhibition. Some studies have shown a correlation between executive disorders (impaired executive function) and psychiatric disorders such as obsessive-compulsive disorder or phobias. These executive disorders are related to dysfunctions of the fronto-striatal loops.
In addition, other studies have investigated the link that may exist between eating disorders such as anorexia or bulimia nervosa and executive functioning. Anorexia nervosa, bulimia nervosa and binge eating disorders are eating disorders characterized by a dysfunction in food intake with restriction of food or compulsions as well as strong concerns about the body schema. Concerning the executive functioning, these studies highlight a lack of cognitive flexibility for patients with anorexia nervosa and bulimia nervosa but also dysfunctions depending on the type of pathology (anorexia nervosa or bulimia nervosa). These studies also highlight the beneficial effects of cognitive remediation on people with eating disorders.
However, the investigation of the inhibitory control has not yet been specifically studied. Moreover, since eating disorders are structurally different, a comparison between several pathologies would be interesting to consider.
The aim of this study is to determine if a dysfunction of inhibitory control can be highlighted in people with eating disorders. This study would also allow further researches about cognitive remediation suitable for the specific difficulties encountered in these diseases.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bron, France, 69500
- Centre Référent pour l'Anorexie et les Troubles du Comportement Alimentaire
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Woman aged 19 to 40 years old
- Patient with a BMI between 13 and 40 kg/m2
- Outpatients of the Refering Center of Eating Disorders ('Hospices Civils de Lyon' in Lyon) suffering of an eating disorder diagnosis (Anorexia Nervosa, Bulimia Nervosa or Binge Eating Disorder)
- Patient who agrees to participate to the study.
Exclusion Criteria:
- Patient with psychiatric comorbidity severe (DSM V) and not stable (during the 8 weeks before inclusion)
- Patient with psychotropic treatment (started or modified during the 8 weeks before inclusion)
- Major patient protected by a measure of legal protection
- Patient younger than 19 years old
- Participation to another study at the same time
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Anorexia Nervosa
Patients with a diagnosis of anorexia nervosa (According to the DSM-V criteria).
These patients are characterized by a restriction of food intake leading to weight loss or a failure to gain weight resulting in a "significantly low body weight" of what would be expected for someone's age, sex and height.
Moreover, there is a fear of becoming fat or of gaining weight.Then, these patients have a distorted view of themselves and of their condition.
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Stroop task is an interference task assessing cognitive inhibitory control. This "paper-and-pencil" task aims to evaluate the inhibition of an automated process such as reading by asking participants to name the color of color names written in a different color ink. This test is non-invasive. Go No Go task assessing motor inhibitory control. This computer-based task is designed to evaluate motor inhibition by asking participants to respond to a stimulus as quickly as possible by inhibiting another distractor stimulus. This test is non-invasive. |
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Bulimia Nervosa
Patients with a diagnosis of bulimia nervosa. According to the DSM-V criteria, these patients are characterized by recurrent episodes of binge eating (eating, in a discrete period of time, an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances), a sense of lack of control over eating during the episode, recurrent inappropriate compensatory behaviour in order to prevent weight gain, such as self-induced vomiting, misuse of laxatives, diuretics, or other medications, fasting, or excessive exercise. The binge eating and inappropriate compensatory behaviours both occur, on average, at least once a week for three months. Moreover, there is a self-evaluation influenced by body shape and weight. |
Stroop task is an interference task assessing cognitive inhibitory control. This "paper-and-pencil" task aims to evaluate the inhibition of an automated process such as reading by asking participants to name the color of color names written in a different color ink. This test is non-invasive. Go No Go task assessing motor inhibitory control. This computer-based task is designed to evaluate motor inhibition by asking participants to respond to a stimulus as quickly as possible by inhibiting another distractor stimulus. This test is non-invasive. |
|
Binge Eating Disorder
Patients with a diagnosis of Binge Eating Disorder.
These patients are characterized by recurrent episodes of binge eating (eating, in a discrete period of time (e.g.
within any 2-hour period), an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances), a sense of lack of control over eating during the episode.
The binge eating episodes are associated with three or more of the following: eating much more rapidly than normal, eating until feeling uncomfortably full, eating large amounts of food when not feeling physically hungry, eating alone because of feeling embarrassed by how much one is eating, feeling disgusted with oneself, depressed or very guilty afterward,marked distress regarding binge eating is present.
Moreover, binge eating occurs, on average, at least once a week for three months
|
Stroop task is an interference task assessing cognitive inhibitory control. This "paper-and-pencil" task aims to evaluate the inhibition of an automated process such as reading by asking participants to name the color of color names written in a different color ink. This test is non-invasive. Go No Go task assessing motor inhibitory control. This computer-based task is designed to evaluate motor inhibition by asking participants to respond to a stimulus as quickly as possible by inhibiting another distractor stimulus. This test is non-invasive. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Inhibition processes assessment - the Stroop task, Execution time
Time Frame: 1 day
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Execution time in the Stroop task
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1 day
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Inhibition processes assessment - the Stroop task, Errors
Time Frame: 1 day
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Errors in the Stroop task
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1 day
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Inhibition processes assessment - the Go No Go task, Execution time
Time Frame: 1 day
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Execution time in the Go No Go task.
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1 day
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Inhibition processes assessment - the Go No Go task, Variability of execution time
Time Frame: 1 day
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Variability of execution time in the Go No Go task
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1 day
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Inhibition processes assessment - the Go No Go task, Errors
Time Frame: 1 day
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Errors in the Go No Go task
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1 day
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL18_0621
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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