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

Early Onset Anorexia Nervosa Clinical Trial

— COTIDEA  

Official title:

"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"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04479683
• Other study ID #: APHP190069
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: November 2026

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Stordeur Coline, MD
• Phone: +33140032261
• Email: coline.stordeur[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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:

• Group 1 (control group): continuation of full-time hospitalisation until reaching the minimum healthy weight, 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).

• Group 2 (experimental group): Exit from FTH (full-time hospitalisation ) and relay to DH (day hospitalization ) one day per week until the minimum healthy weight. This treatment combines a one-day medical evaluation by a senior psychiatrist, family sessions (parents group and multi-family therapy session), a therapeutic education group, a cognitive remediation group and a dietary follow-up with therapeutic meals.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• Environmental indication for continued full-time hospitalization according to the HAS environmental criteria for full-time hospitalization for anorexia nervosa, 2010, cf. appendix) ;

• History of full-time hospitalisation in our ED unit.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Early Onset Anorexia Nervosa

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Hôpital Robert Debré	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI BMI	body mass index (BMI) at 1 year after admission into FTH	one year
Secondary	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").	3 months, 6 months and 1 year after admission into FTH
Secondary	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
Secondary	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
Secondary	Number of weight recurrences	relapse risk assessment	12 months
Secondary	number of rehospitalization days	relapse risk assessment	12 months
Secondary	Quality of life of patients and parents	Score on the satisfaction questionnaire (CSQ 8 and SF12)	6 months and 12 months
Secondary	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
Secondary	anxiety and depression	The evolution of anxiety by Children Depression Inventory scale and State-Trait Anxiety Inventory	at normalization of physiological parameters,12 months
Secondary	Self-esteem	The evolution of self-esteem by Rosenberg self-esteem scale	at normalization of physiological parameters,12 months