COmparison Between Continued Inpatient Treatment Versus Day Patient Treatment in Early Onset Anorexia Nervosa

NCT04479683 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-09-30

No results posted yet for this study

Summary

"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.

Conditions

  • Early Onset Anorexia Nervosa

Interventions

OTHER

FTH then DH support

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.

OTHER

standard care

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Stordeur Coline, MD · APHP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2027-11-30
Completion
2027-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04479683 on ClinicalTrials.gov