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

Eating Disorder Clinical Trial

— NEUROPSY_TCA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03160443
• Other study ID #: 9804
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 3, 2017
• Est. completion date: July 30, 2022

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ...).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 340
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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 (ßHCG) will be performed to ensure the absence of pregnancy.

Related Conditions & MeSH terms

• Disease
• Eating Disorder
• Feeding and Eating Disorders

Intervention

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)

Locations

Country	Name	City	State
France	Hôpital Lapeyronie	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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