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Completed

NCT Number: NCT04091477

Impact of Neuropsychological Alteration of Patients With Eating Disorders

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 ...).

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Key information

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

The investigators will recruit a total of 200 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with an eating disorder according to 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 protected by law (guardianship or curatorship)
  • Pregnant or nursing women. A dosage of βHCG will be performed to ensure the absence of pregnancy.

Treatment and study plan

Primary outcomes

  1. Level of functional impairment assessed by the clinician with the FAST scale

    Time frame: 1 day

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

    The Functioning Assessment Short Test (FAST) is composed of 24 items assessing various dimensions of daily functionning. Each item is ranged from 0 (no difficulty) to 3 (major difficulty) like a likert scale. The FAST is subdivided in 6 subscales : Autonomy (from 0 to 12), Professional activity (from 0 to 15), Cognitive functioning (from 0 to 15), Finances (from 0 to 6), interpersonal relationships (from 0 to 18) and Hobbies (from 0 to 6). The total score is the sum of the 6 subscales from 0 to 72. A hight score reveal hight difficulties in daily functionning

Secondary outcomes

  1. Decision making assessed by the Iowa Gambling Task

    Time frame: 1 day

    We aim to investigate the link between decision making abnormalities and eating disorder caracteristicus

  2. Level of cognitive flexibility assessed by the Brixton test

    Time frame: 1 day

    We aim to investigate the link between cognitive flexibility abnormalities and eating disorder caracteristicus

  3. Level of central coherence assessed by the Rey Figure Test

    Time frame: 1 day

    We aim to investigate the link between central coherence abnormalities and eating disorder caracteristicus

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • INSERM 1061-Montpellier

Registry information

Official study title

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

Acronym: NeuropsyTCA

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 16, 2019
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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