Impairment of Central Coherence in Restrictive Anorexia Nervosa (CoCA)
CoCA
1 other identifier
interventional
122
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedStudy Start
First participant enrolled
June 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2017
CompletedMarch 29, 2018
September 1, 2017
2.2 years
February 10, 2015
March 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Percentages for types I and III of the copy of the figure of Rey
90 minutes
Secondary Outcomes (2)
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
Study Arms (2)
Patients
OTHERpatients followed in the addiction service of the University Hospital of Nantes (consultations and / or hospitalizations) for restrictive anorexia nervosa
Healthy volunteers
OTHERcontrol subjects matched for age and sex with the patients
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nantes, Service d'Addictologie
Nantes, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennyfer CHOLET
Service d'Addictologie, CHU de Nantes, 44093 Nantes cedex 01, FRANCE
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2015
First Posted
March 6, 2015
Study Start
June 11, 2015
Primary Completion
August 16, 2017
Study Completion
August 16, 2017
Last Updated
March 29, 2018
Record last verified: 2017-09