Impairment of Central Coherence in Restrictive Anorexia Nervosa (CoCA) (CoCA)

Impairment of Central Coherence in Restrictive Anorexia Nervosa: Single-center and Case-control Study

The current etiological pathological model of anorexia nervosa is poly-factorial involving individual genetic and psychological factors, in close interaction with environmental, family and socio-cultural factors.

Among these factors, this study focuses on the central coherence process (cognitive ability to integrate complex information into a comprehensive meaning), in the active phase of the disease. Therefore, patients followed in the addiction service of the Nantes University Hospital will perform neuropsychological tests assessing executive functions involved in the process of central coherence.

Impairment of central coherence process could act as a maintenance factor of the disease, particularly in connection with body dysmorphic disorder. The therapeutic perspectives acting on the central coherence process like cognitive remediation deserve to deepen knowledge on the cognitive profile of patients with anorexia nervosa.

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Behavioral: One interview of 90 minutes with a part of cognitive assessment and a part of self-assessment

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • CHU de Nantes, Service d'Addictologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• For the patients :

  • Woman.
  • Aged of more than 15 years and 3 months.
  • Followed in the addiction service of the University Hospital of Nantes (consultations and / or hospitalizations) for Restrictive Anorexia Nervosa (according to the diagnostic criteria of DSM-IV-TR).
  • French language mastered.
  • Having signed the consent if major and if not the legal representatives have signed the consent (for minors).

• For the volunteers :

  • Women.
  • Aged of more than 15 years and 3 months.
  • French language mastered.
  • Having signed the consent if major and if not the legal representatives have signed the consent (for minors).

Exclusion Criteria:

• For the patients :

  • Man
  • Age under 15 years and 3 months old
  • Current Renutrition by nasogastric tube

  • Personal history of:

    • Head injury, neurodegenerative diseases, epilepsy unbalanced, unbalanced endocrine disorder, mental retardation
    • Support for current or past cognitive remediation
  • Opposition of the patient and / or his legal representatives if minor
  • Subject under legal guardianship
  • Current participation or in the past to pharmacological research protocol (time since the end of their participation in the protocol less than one year)
  • French language not mastered

• For the volunteers :

  • Man
  • Age under 15 years and 3 months old
  • Current Renutrition by nasogastric tube

  • Personal history of:

    • Eating disorders
    • Head injury, neurodegenerative diseases, epilepsy unbalanced, unbalanced endocrine disorder, mental retardation
    • Support for current or past cognitive remediation
  • Opposition of the volunteer and / or his legal representatives if minor
  • Subject under legal guardianship
  • Current participation or in the past to pharmacological research protocol (time since the end of their participation in the protocol less than one year)
  • French language not mastered

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients; patients followed in the addiction service of the University Hospital of Nantes (consultations and / or hospitalizations) for restrictive anorexia nervosa	Behavioral: One interview of 90 minutes with a part of cognitive assessment and a part of self-assessment; The content of the assessment will be the same for all subjects and will consist of a part of cognitive assessment (National Reading Test, Rey Osterreich Complex Figure, Hayling Sentence Completion Task, verbal memory, digit sequencing, token motor task, verbal fluencies, symbol coding, tower of London) and self-assessment (Mini International Neuropsychiatric Interview, Beck Depression Inventory, State Trait Anxiety Inventory, Wender Utah Rating Scale, Adult Self-Report Scale Symptom Checklist, UPPS Impulsive Behavior Scale)
Other: Healthy volunteers; control subjects matched for age and sex with the patients	Behavioral: One interview of 90 minutes with a part of cognitive assessment and a part of self-assessment; The content of the assessment will be the same for all subjects and will consist of a part of cognitive assessment (National Reading Test, Rey Osterreich Complex Figure, Hayling Sentence Completion Task, verbal memory, digit sequencing, token motor task, verbal fluencies, symbol coding, tower of London) and self-assessment (Mini International Neuropsychiatric Interview, Beck Depression Inventory, State Trait Anxiety Inventory, Wender Utah Rating Scale, Adult Self-Report Scale Symptom Checklist, UPPS Impulsive Behavior Scale)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentages for types I and III of the copy of the figure of Rey	90 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Average scores for all cognitive and psychiatric tests	90 minutes
Measure of relationships between average scores for all cognitive and psychiatric tests and socio-demographic and clinical data	90 minutes

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Jennyfer CHOLET, Service d'Addictologie, CHU de Nantes, 44093 Nantes cedex 01, FRANCE

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2015
• Primary Completion (Actual): August 16, 2017
• Study Completion (Actual): August 16, 2017

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 6, 2015

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: RC14_0301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No