Impact of Neuropsychological Alteration of Decision-making Abilities on the Functioning of Patients With Eating Disorders (NEUROPSY_TCA)
Primary Purpose
Eating Disorder
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ambulatory cares in a day-hospital (University Hospital of Montpellier) specialized in the evaluation of eating disorders
Sponsored by
About this trial
This is an interventional other trial for Eating Disorder focused on measuring Anorexia nervosa, Bulimia, Binge eating disorders, Neuropsychology, Neurocognition, Daily functioning
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.
Sites / Locations
- Hôpital Lapeyronie
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Participants
Arm Description
All participants performed the same evaluation: clinical and neuropsychological assessment. All of them are patients with an eating disorder.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Score to decision making test (Iowa gambling task)
We aim to investigate the prognostic value of decision making abnormalities on the rates of recovery
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)
Score to decision making test (Iowa gambling task)
We aim to investigate the prognostic value of decision making abnormalities on daily functioning
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
Score to decision making test (Iowa gambling task)
We aim to investigate the impact of weight recovery on decision making abilities
Full Information
NCT ID
NCT03160443
First Posted
May 11, 2017
Last Updated
December 20, 2021
Sponsor
University Hospital, Montpellier
Collaborators
INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03160443
Brief Title
Impact of Neuropsychological Alteration of Decision-making Abilities on the Functioning of Patients With Eating Disorders
Acronym
NEUROPSY_TCA
Official Title
Impact of Neuropsychological Alteration of Decision-making Abilities on the Functioning of Patients With Eating Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 3, 2017 (Actual)
Primary Completion Date
July 30, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder
Keywords
Anorexia nervosa, Bulimia, Binge eating disorders, Neuropsychology, Neurocognition, Daily functioning
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
340 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants
Arm Type
Other
Arm Description
All participants performed the same evaluation: clinical and neuropsychological assessment.
All of them are patients with an eating disorder.
Intervention Type
Behavioral
Intervention Name(s)
Ambulatory cares in a day-hospital (University Hospital of Montpellier) specialized in the evaluation of eating disorders
Intervention Description
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)
Primary Outcome Measure Information:
Title
Level of functional impairment assessed by the Work and Social Adjustment Scale (WSAS)
Description
We aim to investigate the link between decision-making and daily functioning of patients with eating disorder.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Quality of life assessed by the Eating disorder quality of life (EDQOL) scale.
Description
We aim to investigate the link between quality of life and alteration of cognitive flexibility of patients with eating disorder.
Time Frame
Baseline
Title
Level of functional impairment assessed by the clinician with the Functional Assessment Staging Test (FAST) scale
Description
We aim to investigate the link between global functioning and alteration of cognitive flexibility of patients with eating disorder.
Time Frame
Baseline
Title
Quality of life assessed by the Eating disorder quality of life (EDQOL) scale.
Description
We aim to investigate the link between quality of life and alteration central coherence of patients with eating disorder.
Time Frame
Baseline
Title
Level of functional impairment assessed by the clinician with the FAST scale
Description
We aim to investigate the link between global functioning and alteration central coherence of patients with eating disorder.
Time Frame
Baseline
Title
Score to decision making test (Iowa gambling task)
Description
We aim to investigate the prognostic value of decision making abnormalities on the rates of recovery
Time Frame
At 12 months if patient is included in the ancillary study
Title
Score to decision making test (Iowa gambling task)
Description
We aim to investigate the prognostic value of decision making abnormalities on weight recovery (for anorexic patients)
Time Frame
At 12 months if patient is included in the ancillary study
Title
Score to decision making test (Iowa gambling task)
Description
We aim to investigate the prognostic value of decision making abnormalities on daily functioning
Time Frame
At 12 months if patient is included in the ancillary study
Title
Score to decision making test (Iowa gambling task)
Description
We aim to investigate the prognostic value of decision making abnormalities on switch to another subtype of eating disorder
Time Frame
At 12 months if patient is included in the ancillary study
Title
Score to decision making test (Iowa gambling task)
Description
We aim to investigate the impact of weight recovery on decision making abilities
Time Frame
At 12 months if patient is included in the ancillary study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hôpital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Neuropsychological Alteration of Decision-making Abilities on the Functioning of Patients With Eating Disorders
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