Clinical trial NCT03160443: Impact of Neuropsychological Alteration of Decision-making Abilities on the Functioning of Patients With Eating Disorders
Official title: Impact of Neuropsychological Alteration of Decision-making Abilities on the Functioning of Patients With Eating Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eating Disorder
Keywords: Anorexia nervosa
Bulimia
Binge eating disorders
Neuropsychology
Neurocognition
Daily functioning
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier
First posted: 2017-05-19
Enrollment: 340
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Eating disorders are multifactorial disorders currently conceptualized in a biopsychosocial model, but pathophysiology remains relatively unknown, and robust etiological models to guide treatment are therefore lacking. Different endophenotypes and neurocognitive vulnerability factors have been found in eating disorders including decision making abnormalities. The investigators hypothesize that decision making abnormalities are associated with a lower level of functioning and quality of life which could lead to social and interpersonal difficulties. The investigators also hypothesize that these anomalies are associated with a particular clinical profile (more restrictive profile, more hyperactivity, less insight on the disease and desire for care ...).

Detailed description: The investigators will recruit a total of 340 patients with an eating disorder in the university hospital of Montpellier.

* Participation consists of a one-day visit with a multidisciplinary assessment. No action is specific to research. This is the usual management of patients with eating disorders addressed to our department.
* An ancillary study will be proposed, if the patient is addressed by his general practitioner for an annual evaluation. This second visit will be exactly the same as the initial visit.

Eligibility criteria: Inclusion Criteria:

* Patient with an eating disorder according to Diagnostic and Statistical Manuel of Mental disorders-V (DSM-V) criteria
* Patient aged from 15 to 65 years
* Patient who performs the day-hospital evaluation
* Patient affiliated to a French social security system
* Patient able to understand the nature, the aim and the methodology of the study
* For minor one of the legal guardians gave his consent

Exclusion Criteria:

* Patient in an unstable somatic state (eg severe metabolic disorder making impossible or unreliable neuropsychological assessments)
* Patient's refusal to participate
* Patient on protective measures (guardianship or trusteeship)
* Pregnant or nursing women. A dosage of beta human chorionic gonadotropin (βHCG) will be performed to ensure the absence of pregnancy.

Primary outcomes:
measure: Level of functional impairment assessed by the Work and Social Adjustment Scale (WSAS)
timeFrame: Baseline
Secondary outcomes:
measure: Quality of life assessed by the Eating disorder quality of life (EDQOL) scale.
timeFrame: Baseline
measure: Level of functional impairment assessed by the clinician with the Functional Assessment Staging Test (FAST) scale
timeFrame: Baseline
measure: Quality of life assessed by the Eating disorder quality of life (EDQOL) scale.
timeFrame: Baseline
measure: Level of functional impairment assessed by the clinician with the FAST scale
timeFrame: Baseline
measure: Score to decision making test (Iowa gambling task)
timeFrame: At 12 months if patient is included in the ancillary study
measure: Score to decision making test (Iowa gambling task)
timeFrame: At 12 months if patient is included in the ancillary study
measure: Score to decision making test (Iowa gambling task)
timeFrame: At 12 months if patient is included in the ancillary study
measure: Score to decision making test (Iowa gambling task)
timeFrame: At 12 months if patient is included in the ancillary study
measure: Score to decision making test (Iowa gambling task)
timeFrame: At 12 months if patient is included in the ancillary study
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hôpital Lapeyronie
Study officials:
References: