NCT03850288

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2020

Completed
Last Updated

March 6, 2023

Status Verified

January 1, 2023

Enrollment Period

10 months

First QC Date

February 15, 2019

Last Update Submit

March 3, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Inhibition processes assessment - the Stroop task, Execution time

    Execution time in the Stroop task

    1 day

  • Inhibition processes assessment - the Stroop task, Errors

    Errors in the Stroop task

    1 day

  • Inhibition processes assessment - the Go No Go task, Execution time

    Execution time in the Go No Go task.

    1 day

  • Inhibition processes assessment - the Go No Go task, Variability of execution time

    Variability of execution time in the Go No Go task

    1 day

  • Inhibition processes assessment - the Go No Go task, Errors

    Errors in the Go No Go task

    1 day

Study Arms (3)

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.

Other: Neuropsychological assessment : Stroop taskOther: Neuropsychological assessment : Go No Go task

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.

Other: Neuropsychological assessment : Stroop taskOther: Neuropsychological assessment : Go No Go task

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

Other: Neuropsychological assessment : Stroop taskOther: Neuropsychological assessment : Go No Go task

Interventions

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.

Anorexia NervosaBinge Eating DisorderBulimia Nervosa

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.

Anorexia NervosaBinge Eating DisorderBulimia Nervosa

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women aged 19 to 40 years old, with a BMI between 13 and 40 kg/m2, outpatients of the Refering Center of Eating Disorders ('Hospices Civils de Lyon' in Lyon), with an eating disorder diagnosis (Anorexia Nervosa, Bulimia Nervosa or Binge Eating Disorder).

You may qualify if:

  • 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.

You may not qualify if:

  • Major patient protected by a measure of legal protection
  • Patient younger than 19 years old
  • Participation to another study at the same time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Référent pour l'Anorexie et les Troubles du Comportement Alimentaire

Bron, 69500, France

Location

MeSH Terms

Conditions

Anorexia NervosaBulimia NervosaBulimia

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersHyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2019

First Posted

February 21, 2019

Study Start

May 15, 2019

Primary Completion

February 26, 2020

Study Completion

February 26, 2020

Last Updated

March 6, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations