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Clinical Trials/NCT06252688
NCT06252688
Not yet recruiting
Not Applicable

Conceptualisation of a Network Approach to Complete the Classification of Eating Disorders With the Aim of Better Personalising Their Management

University Hospital, Montpellier0 sites840 target enrollmentFebruary 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Eating Disorders
Sponsor
University Hospital, Montpellier
Enrollment
840
Primary Endpoint
Eating Disorders Inventory (EDI-2)
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

Eating disorders (EDBs) are mental disorders with a great impact on the lives of individuals as well as a great cost imposed on society. The treatments currently available rely on different forms of psychotherapies with an unsatisfactory response rate as well as a considerable relapse rate . One of the reasons underlying the low success of available therapeutic modalities would be the heterogeneity of the clinical presentation of EDs, making their classification and the personalization of their treatment more difficult.The investigators hypothesize that a secondarily dimensional classification approach (respecting the categorical classification currently in use) of EDs based on the different dimensions disturbed in these disorders as well as in their comorbidities, would better represent their nosographic reality, which could provide patients with more personalized and potentially more effective care.

Detailed Description

Detailed Description: The investigators will recruit a total of 840 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 except the biological collection for the constitution of a genetic bank. This is the usual management of patients with eating disorders addressed to our department.

Registry
clinicaltrials.gov
Start Date
February 15, 2024
End Date
November 15, 2031
Last Updated
2 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 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

Outcomes

Primary Outcomes

Eating Disorders Inventory (EDI-2)

Time Frame: Baseline

self-questionnaire of 91 items aimed at evaluating attitudes and behaviors related to food and allowing the identification of 11 dimensions: search for thinness, bulimia, body dissatisfaction, inefficiency, perfectionism, interpersonal distrust, interoceptive awareness, fear of maturity , asceticism, impulse control, social insecurity. The higher the subscore, the more severely impaired the dimension concerned is.

Eating Disorder Examination Questionnaire (EDE-Q)

Time Frame: Baseline

Self-reported version of the gold-standard clinical interview for ED assessing the intensity of eating symptoms over the last 28 days. A total score as well as 4 sub-scores (restriction, diet, weight, shape) varying from 0 to 6 are thus obtained.

Secondary Outcomes

  • The relationship between BMI and calorimetry data(Baseline)
  • Yale Food Addiction Scale (YFAS)(baseline)
  • exercice and Eating disorders questionnaire (EED)(baseline)
  • Detail and flexibility questionnaire (Dflex)(baseline)
  • d2 attention test(Baseline)
  • The relationship between disease duration and the biological parameters of the blood test(Baseline)
  • Symptomatic dimensions of Eating Disorder Examination Questionnaire (EDEQ)(baseline)
  • Sociocultural Attitudes Towards Appearance Scale (SATAQ-4)(baseline)
  • Female drive for muscularity scale (FDMS)(baseline)
  • The disgust propensity and sensitivity scale (DPSS-R)(Baseline)
  • Wisconsin test (WCST-64)(Baseline)
  • Delay discounting task (DDT)(Baseline)
  • Mini International Neuropsychiatric Interview(Baseline)
  • The relationship between BMI and the biological parameters of the blood test(Baseline)
  • Childhood Trauma Questionnaire (CTQ)(baseline)
  • The anxiety scale (GAD-7)(baseline)
  • The insomnia severity index (ISI)(baseline)
  • The emotional regulation scale (DERS-F)(baseline)
  • Rey's figure(baseline)
  • Body Shape Questionnaire (BSAQ-34)(baseline)
  • depression scale (PQ-9)(baseline)
  • The Sheehan Global Functioning Scale (SDS)(baseline)
  • The relationship between disease duration and calorimetry data(Baseline)
  • The relationship between BMI of TCA and bone densitometry data(Baseline)
  • The relationship between BMI and impedancemetry data(Baseline)
  • The relationship between disease duration and impedancemetry data(Baseline)

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