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"In so-called ""early onset"" anorexia nervosa (AN), a rare and severe form affecting 8-13 year olds, experts recommend that, as soon as possible, treatment should take place on an outpatient basis, at an age when separation from the usual environment would be particularly unpleasant and deleterious. However, in severe AN, full-time hospitalisation (FTH) is still indicated when somatic and psychiatric instability criteria are met. Thus, the severity and rapidity of undernutrition in children aged 8-13 years suffering from AN (linked on the one hand to the frequency of total aphagia with refusal to drink and on the other hand to the lack of early detection of the disorder, frequently requires emergency FTH, contrary to expert recommendations. This FTH, which lasts on average 3 months in our specialized unit, has certain disadvantages: poor acceptability by the patient and/or his family, increased anxiety symptoms on entry and exit, school dropout, social isolation, coercive experience. In addition, the rate of premature FTH exits - before weight targets are reached - and the frequency of relapses after FTH remain high, making FTH unsatisfactory in terms of cost-effectiveness. Some families refuse FTH, which is classically long, exposing themselves to the risk of complications that can occur if the disorder is inadequately treated: somatic, acute and chronic complications; risk of progression to another eating disorder.
In recent years, day hospitalization (DH) care has been developed for adolescents aged 11 to 18 years and adults (Madden, 2015). The few studies available are in favour of comparable efficacy, better acceptability and lower cost in the management of moderate AN compared to prolonged FTH, but also better social adaptation.In children aged 8 to 13 years with AN, whose somatic condition requires continuous monitoring in a hospital setting (the usual indication for FTH), a DH cannot reasonably be proposed immediately given the severity of the situation. Our hypothesis is that it would however be possible, in these children, to shorten the duration of FTH and to continue DH treatment once the critical period has passed at the somatic level, with comparable efficacy, best acceptability, best progress in terms of school and social integration, and lower cost.
The objective of the study is to demonstrate the non-inferiority of DH management after a short full-time hospitalisation compared to a prolonged full-time hospitalisation aiming at a healthy weight on the evolution of BMI at 1 year in children aged 8 to 13 years suffering from anorexia nervosa, with severe undernutrition.
The minimum healthy weight is defined by a weight corresponding to the BMI corridor prior to the diagnosis of anorexia nervosa, +/- 1 corridor).
Randomized controlled trial, open-label, single-centre.
Patients will be randomized into one of the two arms of the trial:
Statistical analysis of the data will be carried out with the intention to treat. The BMI at 1 year between groups, as well as its bilateral 95% confidence interval (equivalent to a one-sided 97.5% confidence interval), will be estimated and compared with the predefined margin of non-inferiority (1 BMI point).
Ancillary study : Addition of a qualitative study conducted with parents to evaluate the implementation of a weekly intensive day hospital in the treatment of early-onset anorexia nervosa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard care | Other | continuation of full-time hospitalization until the minimum healthy weight is reached, defined as the weight corresponding to the return to the previous BMI corridor (previous BMI +/- 1 BMI corridor, e.g. change from 25th to 10th percentile). This management combines bi-weekly medical follow-up by a senior psychiatrist, weekly family work, weekly therapeutic education group, weekly cognitive remediation group and bi-weekly dietary follow-up with therapeutic meals. |
|
| FTH (full-time hospitalisation) then day hospitalization) | Experimental | FTH output and DH relay one day a week until the minimum healthy weight. This treatment combines over one day a medical evaluation by a senior psychiatrist, family work (parents group and multi-family therapy session), a therapeutic education group, a cognitive remediation group and a dietary follow-up with therapeutic meals. During this phase, all children are evaluated once a week on a somatic level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FTH then DH support | Other | FTH output and DH relay one day a week until the minimum healthy weight. This treatment combines over one day a medical evaluation by a senior psychiatrist, family work (parents group and multi-family therapy session), a therapeutic education group, a cognitive remediation group and a dietary follow-up with therapeutic meals. During this phase, all children are evaluated once a week on a somatic level. |
| Measure | Description | Time Frame |
|---|---|---|
| BMI BMI | body mass index (BMI) at 1 year after admission into FTH | one year |
| Measure | Description | Time Frame |
|---|---|---|
| global clinical state | Clinical global impression scale (CGI).Two "sub-scores": CGI-gravity and CGI-improvement. CGI-gravity measures the severity of a subject's current clinical condition (from 1 "normal, not at all sick" to 7 "among the sickest patients"). The improvement measures the perceived improvement in clinical status between assessments (rated from 1 "Very Much Improved" to 7 "Very Much Worsened"). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stordeur Coline, MD | Contact | +33140032261 | coline.stordeur@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Stordeur Coline, MD | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Robert Debré | Recruiting | Paris | 75019 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37817147 | Derived | Ayrolles A, Bargiacchi A, Clarke J, Michel M, Baillin F, Trebossen V, Kalifa HP, Guilmin-Crepon S, Delorme R, Godart N, Stordeur C. Comparison between continued inpatient treatment versus day patient treatment after short inpatient care in early onset anorexia nervosa (COTIDEA trial): a study protocol for a non-inferiority randomised controlled trial. BMC Psychiatry. 2023 Oct 10;23(1):730. doi: 10.1186/s12888-023-05222-9. |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| standard care | Other | continuation of full-time hospitalization until the minimum healthy weight is reached, defined as the weight corresponding to the return to the previous BMI corridor (previous BMI +/- 1 BMI corridor, e.g. change from 25th to 10th percentile). This management combines bi-weekly medical follow-up by a senior psychiatrist, weekly family work, weekly therapeutic education group, weekly cognitive remediation group and bi-weekly dietary follow-up with therapeutic meals. |
|
| 3 months, 6 months and 1 year after admission into FTH |
| Weight | Evaluate a healthy weight of a FTH intervention then DH versus conventional treatment | at normalization of physiological parameters,3 months, 6 months and 1 year after admission into FTH |
| Height | Evaluate a height of a FTH intervention then DH versus conventional treatment | at normalization of physiological parameters,3 months, 6 months and 1 year after admission into FTH |
| Number of weight recurrences | relapse risk assessment | 12 months |
| number of rehospitalization days | relapse risk assessment | 12 months |
| Quality of life of patients and parents | Score on the satisfaction questionnaire (CSQ 8 and SF12) | 6 months and 12 months |
| Cost FTH then DH versus conventional treatment | Evaluate the efficiency of the FTH then DH versus FTH alone through a cost-utility analysis, and perform a cost-effectiveness analysis. | 12 months |
| anxiety and depression | The evolution of anxiety by Children Depression Inventory scale and State-Trait Anxiety Inventory | at normalization of physiological parameters,12 months |
| Self-esteem | The evolution of self-esteem by Rosenberg self-esteem scale | at normalization of physiological parameters,12 months |