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Clinical Trials/NCT03160443
NCT03160443
Unknown
Not Applicable

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

University Hospital, Montpellier1 site in 1 country340 target enrollmentMay 3, 2017
ConditionsEating Disorder

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Eating Disorder
Sponsor
University Hospital, Montpellier
Enrollment
340
Locations
1
Primary Endpoint
Level of functional impairment assessed by the Work and Social Adjustment Scale (WSAS)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 3, 2017
End Date
July 30, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

Time Frame: Baseline

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

Secondary Outcomes

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

Study Sites (1)

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