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

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 ...).

Study Overview

• Status: Active, not recruiting
• Conditions: Eating Disorder
• Intervention / Treatment: Behavioral: Ambulatory cares in a day-hospital (University Hospital of Montpellier) specialized in the evaluation of eating disorders

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.

• Study Type: Interventional
• Enrollment (Anticipated): 340
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Hopital Lapeyronie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Participants; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life assessed by the Eating disorder quality of life (EDQOL) scale.	We aim to investigate the link between quality of life and alteration of cognitive flexibility of patients with eating disorder.	Baseline
Level of functional impairment assessed by the clinician with the Functional Assessment Staging Test (FAST) scale	We aim to investigate the link between global functioning and alteration of cognitive flexibility of patients with eating disorder.	Baseline
Quality of life assessed by the Eating disorder quality of life (EDQOL) scale.	We aim to investigate the link between quality of life and alteration central coherence of patients with eating disorder.	Baseline
Level of functional impairment assessed by the clinician with the FAST scale	We aim to investigate the link between global functioning and alteration central coherence of patients with eating disorder.	Baseline
Score to decision making test (Iowa gambling task)	We aim to investigate the prognostic value of decision making abnormalities on the rates of recovery	At 12 months if patient is included in the ancillary study
Score to decision making test (Iowa gambling task)	We aim to investigate the prognostic value of decision making abnormalities on weight recovery (for anorexic patients)	At 12 months if patient is included in the ancillary study
Score to decision making test (Iowa gambling task)	We aim to investigate the prognostic value of decision making abnormalities on daily functioning	At 12 months if patient is included in the ancillary study
Score to decision making test (Iowa gambling task)	We aim to investigate the prognostic value of decision making abnormalities on switch to another subtype of eating disorder	At 12 months if patient is included in the ancillary study
Score to decision making test (Iowa gambling task)	We aim to investigate the impact of weight recovery on decision making abilities	At 12 months if patient is included in the ancillary study

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2017
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Neuropsychology; Bulimia; Neurocognition; Anorexia nervosa; Binge eating disorders; Daily functioning
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Feeding and Eating Disorders
• Other Study ID Numbers: 9804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No