Impact of Neuropsychological Alteration of Decision-making Abilities on the Functioning of Patients With Eating Disorders

NCT03160443 | Unknown

• 1 other identifier: 9804
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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 ...).

Conditions

Eating Disorder

Keywords

Anorexia nervosa; Bulimia; Binge eating disorders; Neuropsychology; Neurocognition; Daily functioning

Outcome Measures

Primary Outcomes (1)

• Level of functional impairment assessed by the Work and Social Adjustment Scale (WSAS)

  We aim to investigate the link between decision-making and daily functioning of patients with eating disorder.

  Baseline

Secondary Outcomes (9)

• Quality of life assessed by the Eating disorder quality of life (EDQOL) scale.

  Baseline

• Level of functional impairment assessed by the clinician with the Functional Assessment Staging Test (FAST) scale

  Baseline

• Quality of life assessed by the Eating disorder quality of life (EDQOL) scale.

  Baseline

• Level of functional impairment assessed by the clinician with the FAST scale

  Baseline

• Score to decision making test (Iowa gambling task)

  At 12 months if patient is included in the ancillary study

Study Arms (1)

Participants

OTHER

All participants performed the same evaluation: clinical and neuropsychological assessment. All of them are patients with an eating disorder.

Behavioral: Ambulatory cares in a day-hospital (University Hospital of Montpellier) specialized in the evaluation of eating disorders

Interventions

Ambulatory cares in a day-hospital (University Hospital of Montpellier) specialized in the evaluation of eating disorders BEHAVIORAL

All patients assessed in the day-hospital will performed the same evaluation : * Blood sampling * Calorimetry * Osteodensitometry * Psychiatric assessment * Endocrinologic assessment * Dietetic assessment * Neuropsychological assessment * Self-questionnaires With the patient agreement, a biological collection will be constituted. The objective is the subsequent study of biological factors involved in eating disorders (in particular genetic factors)

Participants

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier: collaborator

Study Sites (1)

Hôpital Lapeyronie

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Bulimia; Binge-Eating Disorder

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Hyperphagia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 19, 2017
• Study Start: May 3, 2017
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)