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

Eating Disorders Clinical Trial

— CASCADE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06252688
• Other study ID #: RECHMPL23_0261
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: November 15, 2031

Study information

• Verified date: September 2023
• Source: University Hospital, Montpellier
• Contact: Sébastien GUILLAUME, PhD
• Phone: +33 4 67 33 82 89
• Email: s-guillaume[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 840
• Est. completion date: November 15, 2031
• Est. primary completion date: November 15, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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 ßHCG will be performed to ensure the absence of pregnancy

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Behavioral:
• Ambulatory cares in a day-hospital (Lapeyronie, Montpellier) specialized in the evaluation of eating disorders.
All patients assessed in the day-hospital will permormed the same evaluation : Blood sampling Calorimetry Osteodensotometry Psychiatric assement 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
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eating Disorders Inventory (EDI-2)	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.	Baseline
Primary	Eating Disorder Examination Questionnaire (EDE-Q)	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.	Baseline
Secondary	Symptomatic dimensions of Eating Disorder Examination Questionnaire (EDEQ)	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.	baseline
Secondary	Body Shape Questionnaire (BSAQ-34)	self-questionnaire of 34 items assessing body dissatisfaction and in particular four dimensions: avoidance and social shame of body exposure, body dissatisfaction with the lower parts of the body, use of laxatives and vomiting to reduce body dissatisfaction, maladaptive cognitions and behaviors in order to control weight. The total score ranges from 0 to 204. A score below 80 indicates no excessive body concerns, a score between 80 and 100 indicates mild concerns, between 111 and 140 moderate concerns, and a score above 140 indicates significant concerns	baseline
Secondary	Yale Food Addiction Scale (YFAS)	35-item Likert-type self-questionnaire assessing the difficulty or not in controlling the quantity of food one eats over the past 12 months, using an 8-point scale from "never" to "all days ". This questionnaire assesses clinical distress based on the DSM-5 diagnostic criteria for substance use disorders. Presenting clinically significant suffering and at least 2 diagnostic criteria suggest a food addiction.	baseline
Secondary	Sociocultural Attitudes Towards Appearance Scale (SATAQ-4)	multidimensional self-questionnaire of 22 items rated from 1 (completely disagree) to 5 (completely agree) aimed at assessing the sociocultural influence of the media on appearance. It includes four subscales: pressures, information, internalization relating to athletes and general internalization. The higher the score, the stronger the influence.	baseline
Secondary	Female drive for muscularity scale (FDMS)	10-item self-questionnaire assessing the desire for muscularity in women. Each item is rated from 1 (never) to 6 (always). A high score indicates a significant search for musculature.	baseline
Secondary	exercice and Eating disorders questionnaire (EED)	self-questionnaire of 21 questions evaluating the different types of exercises (normal and pathological) carried out over the last 4 weeks. A high score suggests physical hyperactivity linked to food and body concerns.	baseline
Secondary	Childhood Trauma Questionnaire (CTQ)	28-item self-questionnaire that assesses past history of childhood abuse. 5 forms of mistreatment are assessed: physical abuse and sexual abuse, emotional abuse and emotional neglect, as well as physical neglect.	baseline
Secondary	depression scale (PQ-9)	self-assessment questionnaire measuring the severity of depression, composed of 9 items rated from 0 to 3. A total score varying from 0 to 27 is thus obtained. The higher the score, the more severe the depression.	baseline
Secondary	The anxiety scale (GAD-7)	self-questionnaire for assessing current anxious symptomatology consists of 7 items rated from 0 to 3. The total score ranges from 0 to 21. The recommended threshold for estimating generalized anxiety is 10.	baseline
Secondary	The insomnia severity index (ISI)	Sleep disorders are common in EDs. The ISI is a self-questionnaire of 5 items rated from 0 to 4 which makes it possible to assess the nature of insomnia, satisfaction with sleep, daily functioning and anxiety in relation to sleep disorders. A total score varying from 0 to 28 makes it possible to assess the severity of insomnia.	baseline
Secondary	The disgust propensity and sensitivity scale (DPSS-R)	This scale of 10 items rated from 1 (never) to 5 (always) assesses sensitivity to disgust and is used to calibrate the level of exposure during treatment. The higher the score, the more sensitive the subjects are to the emotion of disgust.	Baseline
Secondary	The emotional regulation scale (DERS-F)	This scale includes 36 items and aims to assess difficulties in regulating emotions through 6 dimensions: N (Non-acceptance): non-acceptance of one's emotional response, G (Goals): difficulties in adopting goal-oriented behaviors in a negative emotional context, I (Impulse): difficulties in controlling oneself in a negative emotional context, A (Awareness): lack of emotional awareness, S (Strategies): difficulties in implementing emotion regulation strategies in an emotional context negative, C (Clarity): difficulty identifying one's own emotions. The higher the score, the more difficulty the subject presents in regulating their emotions.	baseline
Secondary	The Sheehan Global Functioning Scale (SDS)	measures from 0 to 10, in self-assessment, the intensity of discomfort and handicap felt in three areas of professional, social and family functioning.	baseline
Secondary	Detail and flexibility questionnaire (Dflex)	24-item self-questionnaire measuring two aspects of neurocognitive functioning, rigidity (12 items) and lack of central coherence (12 items), as they manifest in a daily context. The two scores can vary from 12 to 72. The higher they are, the greater the perceived difficulties.	baseline
Secondary	Rey's figure	This is a test of copying and reproducing from memory a complex figure. The test draws on the subject's general intelligence abilities as well as their perceptual structuring skills. The purpose of the test in our study is to assess levels of central coherence (the ability to assess a situation as a whole rather than focusing on details).	baseline
Secondary	d2 attention test	cancellation test where individuals must search for target items "d" with two dots among distractors across a series of 658 consecutively ordered items. Participants are instructed to cancel as many target symbols as possible by moving across the page in a manner similar to reading from left to right with a limit of 20 seconds per trial without interruption. The ratio between the number of omission errors (number of "d"s with two unmarked points) and the total number of items processed was the main variable considered in this study.	Baseline
Secondary	Wisconsin test (WCST-64)	This test explores executive functions using a set of 64 cards illustrated by the combination of three attributes: shape (cross, circle, triangle, star), color (yellow, red, blue, green) and number of figures (of 1 to 4). Four target cards are placed in front of the subject who must find a predetermined classification rule by trial and error. The results are expressed in number of categories completed, percentage of perseverative errors, number of trials necessary to complete the first category and learning capacity.	Baseline
Secondary	Delay discounting task (DDT)	This task evaluates decision-making abilities in a situation of projection into the future and makes it possible to suggest prognoses for development in TCA.	Baseline
Secondary	Mini International Neuropsychiatric Interview	MINI 5.0.0 allowing current and entire life diagnoses according to Axis-I of the DSM-5-TR	Baseline
Secondary	The relationship between BMI and the biological parameters of the blood test	The investigators want to study the link between the BMI and the alteration of the biological balance (ionogram, hetapic, liver function, hematogy corresponding to the standard biological assessment). (weight and height will be combined to report BMI in kg/m^2).	Baseline
Secondary	The relationship between disease duration and the biological parameters of the blood test	The investigators want to study the link between the disease duration and the alteration of the biological balance.	Baseline
Secondary	The relationship between BMI and calorimetry data	The investigators want to study the link between BMI and alteration of basal metabolism . (weight and height will be combined to report BMI in kg/m^2) Basal metabolims is the rate at which the body uses energy while at rest to maintain vital functions such as breathing and keeping warm (in Kcal per day)	Baseline
Secondary	The relationship between disease duration and calorimetry data	The investigators want to study the link between disease duration and alteration of basal metabolism.; Basal metabolims is the rate at which the body uses energy while at rest to maintain vital functions such as breathing and keeping warm (in Kcal per day)	Baseline
Secondary	The relationship between BMI of TCA and bone densitometry data	The investigators want to study the link between BMI and Z score of bone demineralization. (weight and height will be combined to report BMI in kg/m^2) We aimed to asssess level of osteopenia compared to a reference population	Baseline
Secondary	The relationship between BMI and impedancemetry data	The investigators want to study the link between BMI and alterations in body composition (percentage of fat mass). (weight and height will be combined to report BMI in kg/m^2)	Baseline
Secondary	The relationship between disease duration and impedancemetry data	The investigators want to study the link between disease duration (in year) and alterations in body composition (percentage of fat mass).	Baseline