Eating DisordersCASCADENCT06252688
Conceptualisation of a Network Approach to Complete the Classification of Eating Disorders With the Aim of Better Personalising Their Management
A study testing Ambulatory cares in a day-hospital (Lapeyronie, Montpellier) specialized in the evaluation of eating disorders. in people with Eating Disorders and Eating Disorder Binge, run by University Hospital, Montpellier.
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 . Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Eating Disorders, Eating Disorder Binge
- What is being tested?
- Ambulatory cares in a day-hospital (Lapeyronie, Montpellier) specialized in the evaluation of eating disorders.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to 15 Nov 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Eating Disorders, Eating Disorder Binge
- Being tested
- Ambulatory cares in a day-hospital (Lapeyronie, Montpellier) specialized in the evaluation of eating disorders.
- Keywords
- Anorexia nervosa, Bulimia, Binge eating disorders, Neuropsychology, Neurocognitiond, Daily functioning
- Medical subject headings
- Feeding and Eating Disorders, Binge-Eating Disorder, Anorexia Nervosa, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory cares in a day-hospital (Lapeyronie, Montpellier) specialized in the evaluation of eating disorders.Behavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Participants | Other | All participants performed the same evaluation: clinical and neuropsychological assessment.
All of them are patients with an eating disorder. Receives: Behavioral: Ambulatory cares in a day-hospital (Lapeyronie, Montpellier) specialized in the evaluation of eating disorders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Baseline
Secondary outcomes (26)
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.
Measured: baseline
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
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: Baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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).
Measured: baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Mini International Neuropsychiatric Interview
MINI 5.0.0 allowing current and entire life diagnoses according to Axis-I of the DSM-5-TR
Measured: Baseline
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).
Measured: Baseline
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.
Measured: Baseline
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)
Measured: Baseline
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)
Measured: Baseline
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
Measured: Baseline
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)
Measured: Baseline
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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion15 Nov 2031 (estimated)
- Study completion15 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252688
- Sponsor's protocol ID
- RECHMPL23_0261
- Acronym
- CASCADE
- Status last verified
- Sep 2023
- First submitted
- 17 Nov 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conceptualisation of a Network Approach to Complete the Classification of Eating Disorders With the Aim of Better Personalising Their Management
- ClinicalTrials.gov ID
- NCT06252688
- Acronym / sponsor ID
- CASCADE / RECHMPL23_0261
- Conditions
- Eating Disorders, Eating Disorder Binge
- Keywords
- Anorexia nervosa, Bulimia, Binge eating disorders, Neuropsychology, Neurocognitiond, Daily functioning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 15 Nov 2031 (estimated)
- Study completion
- 15 Nov 2031 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Other | Behavioral: Ambulatory cares in a day-hospital (Lapeyronie, Montpellier) specialized in the evaluation of eating disorders.All participants performed the same evaluation: clinical and neuropsychological assessment. All of them are patients with an eating disorder. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | Participants |
Primary outcome
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.
26 secondary outcomes
Symptomatic dimensions of Eating Disorder Examination Questionnaire (EDEQ)
Time frame: baseline
Body Shape Questionnaire (BSAQ-34)
Time frame: baseline
Yale Food Addiction Scale (YFAS)
Time frame: baseline
Sociocultural Attitudes Towards Appearance Scale (SATAQ-4)
Time frame: baseline
Female drive for muscularity scale (FDMS)
Time frame: baseline
exercice and Eating disorders questionnaire (EED)
Time frame: baseline
Childhood Trauma Questionnaire (CTQ)
Time frame: baseline
depression scale (PQ-9)
Time frame: baseline
The anxiety scale (GAD-7)
Time frame: baseline
The insomnia severity index (ISI)
Time frame: baseline
The disgust propensity and sensitivity scale (DPSS-R)
Time frame: Baseline
The emotional regulation scale (DERS-F)
Time frame: baseline
The Sheehan Global Functioning Scale (SDS)
Time frame: baseline
Detail and flexibility questionnaire (Dflex)
Time frame: baseline
Rey's figure
Time frame: baseline
d2 attention test
Time frame: Baseline
Wisconsin test (WCST-64)
Time frame: Baseline
Delay discounting task (DDT)
Time frame: Baseline
Mini International Neuropsychiatric Interview
Time frame: Baseline
The relationship between BMI and the biological parameters of the blood test
Time frame: Baseline
The relationship between disease duration and the biological parameters of the blood test
Time frame: Baseline
The relationship between BMI and calorimetry data
Time frame: Baseline
The relationship between disease duration and calorimetry data
Time frame: Baseline
The relationship between BMI of TCA and bone densitometry data
Time frame: Baseline
The relationship between BMI and impedancemetry data
Time frame: Baseline
The relationship between disease duration and impedancemetry data
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory cares in a day-hospital (Lapeyronie, Montpellier) specialized in the evaluation of eating disorders. in people with Eating Disorders and Eating Disorder Binge, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sébastien GUILLAUME, PhD (+33 4 67 33 82 89, s-guillaume@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorders Inventory (EDI-2) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.