COmparison Between Continued Inpatient Treatment Versus Day Patient Treatment in Early Onset Anorexia Nervosa
A legfontosabb adatok
- Ki végzi
- Assistance Publique - Hôpitaux de Paris
- Hol
- Franciaország1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Fut, nem toboroz
- Résztvevők
- 88 fő, tervezett
- Kezdés
- 2021. máj. 10.
- Várható befejezés
- 2027. nov.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoport
- A vizsgált kezelések
- FTH then DH support
- standard care
- A regiszteradat frissítve
- 2026. október 7.
Ki vehet részt
- Életkor
- 8 év – 13 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 11 feltétel megnézéseKevesebb
Ki vehet részt
- Anorexia Nervosa according to diagnostic mental disorders(DSM 5) criteria
- Age at diagnosis 8 to 13 years inclusive
- Indication for full-time hospitalisation according to supreme health authority (HAS 2010) criteria, see appendix
- First hospitalization in the Eating Disorders (ED) unit of the Child and Adolescent Psychiatry Department at Robert Debré Hospital
- Informed consent of the holder(s) of parental authority
- Patient affiliated to a social security
Ki nem vehet részt
- Other early onset eating disorders (ARFID to DSM 5 criteria)
- Underlying unbalanced somatic disease (especially gastroenterological)
- Psychiatric indication for continued hospitalisation (in particular significant suicidal risk according to the psychiatric criteria for full-time hospitalisation for anorexia nervosa of the HAS, 2010, cf. appendix)
- History of full-time hospitalisation in our ED unit
- Environmental indication for continued full-time hospitalization according to the HAS environmental criteria for full-time hospitalization for anorexia nervosa, 2010, cf. appendix)
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A vizsgálatról
Mit akar kideríteni a vizsgálat
"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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat 2 csoportja
- standard careEgyéb csoport
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)A vizsgált kezelés
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.
Kezelés: FTH then DH support
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- "COTIDEA COmparison Between Continued Inpatient Treatment Versus Day Patient Treatment (Partial Hospitalization) After Short Inpatient Care in Early Onset Anorexia Nervosa: a Non-inferiority Trial A Non-inferiority Study"
- Publikációk
- A regiszteradat frissítve
- 2026. október 7.