Impairment of Central Coherence in Restrictive Anorexia Nervosa (CoCA)

NCT ID: NCT02381639

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-11
• Study Completion Date: 2017-08-16

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.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients

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

Group Type: OTHER

One interview of 90 minutes with a part of cognitive assessment and a part of self-assessment

Intervention Type: BEHAVIORAL

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)

Healthy volunteers

control subjects matched for age and sex with the patients

Group Type: OTHER

One interview of 90 minutes with a part of cognitive assessment and a part of self-assessment

Intervention Type: BEHAVIORAL

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)

Interventions

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)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennyfer CHOLET

Role: PRINCIPAL_INVESTIGATOR

Service d'Addictologie, CHU de Nantes, 44093 Nantes cedex 01, FRANCE

Locations

CHU de Nantes, Service d'Addictologie

Nantes, , France

Countries

France

Other Identifiers

RC14_0301

Identifier Type: -

Identifier Source: org_study_id