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

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
One interview of 90 minutes with a part of cognitive assessment and a part of self-assessment
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anorexia Nervosa

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Nantes, Service d'Addictologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients

Healthy volunteers

Arm Description

patients followed in the addiction service of the University Hospital of Nantes (consultations and / or hospitalizations) for restrictive anorexia nervosa

control subjects matched for age and sex with the patients

Outcomes

Primary Outcome Measures

Percentages for types I and III of the copy of the figure of Rey

Secondary Outcome Measures

Average scores for all cognitive and psychiatric tests
Measure of relationships between average scores for all cognitive and psychiatric tests and socio-demographic and clinical data

Full Information

First Posted
February 10, 2015
Last Updated
March 28, 2018
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02381639
Brief Title
Impairment of Central Coherence in Restrictive Anorexia Nervosa (CoCA)
Acronym
CoCA
Official Title
Impairment of Central Coherence in Restrictive Anorexia Nervosa: Single-center and Case-control Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 11, 2015 (Actual)
Primary Completion Date
August 16, 2017 (Actual)
Study Completion Date
August 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Other
Arm Description
patients followed in the addiction service of the University Hospital of Nantes (consultations and / or hospitalizations) for restrictive anorexia nervosa
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
control subjects matched for age and sex with the patients
Intervention Type
Behavioral
Intervention Name(s)
One interview of 90 minutes with a part of cognitive assessment and a part of self-assessment
Intervention Description
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)
Primary Outcome Measure Information:
Title
Percentages for types I and III of the copy of the figure of Rey
Time Frame
90 minutes
Secondary Outcome Measure Information:
Title
Average scores for all cognitive and psychiatric tests
Time Frame
90 minutes
Title
Measure of relationships between average scores for all cognitive and psychiatric tests and socio-demographic and clinical data
Time Frame
90 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennyfer CHOLET
Organizational Affiliation
Service d'Addictologie, CHU de Nantes, 44093 Nantes cedex 01, FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nantes, Service d'Addictologie
City
Nantes
Country
France

12. IPD Sharing Statement

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Impairment of Central Coherence in Restrictive Anorexia Nervosa (CoCA)

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