Evaluation of Hospitalization for Anorexia Nervosa (EVALuation de l'Apport de l'HOSPITalisation Pour Anorexie Mentale : EVALHOSPITAM)

Anorexia Nervosa Clinical Trial

— EVHAN  

Official title:

Evaluation of Hospitalization for Anorexia Nervosa: Efficacy of Treatment and Predictive Factors of Outcome.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00910169
• Other study ID #: Eudract: 2007 -A01110-53
• Secondary ID: ANR-0-JC0719-632
• Status: Active, not recruiting
• Phase: N/A
• First received: May 26, 2009
• Last updated: August 6, 2012
• Start date: March 2009
• Est. completion date: October 2012

Study information

• Verified date: May 2009
• Source: Institut Mutualiste Montsouris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Direction Générale de la SantéFrance: Institutional Ethical Committee
• Study type: Observational

Clinical Trial Summary

The objective of this research is to evaluate the efficacy of five different in-patient treatment modalities and predictive factors of outcome for anorexia nervosa. The primary hypothesis is that the different treatment types impact outcome of patients at discharge from inpatient treatment and at one year follow-up, even after adjustment for confounding factors (age, length of illness, number of previous hospitalizations, clinical state at intake).

Description:

This study will evaluate global, psychiatric, somatic and psychosocial outcome for inpatients with anorexia nervosa through three evaluations (intake, discharge and one-year follow-up). The study will also consider five types of in-patient treatment in a naturalistic setting (i.e., patients will not be assigned to different treatment conditions; rather, we will study inpatient care as it exists today). The five treatment modalities to be studied are:

1. Discharge weight objectives.

2. The practice of a separation period.

3. The use of clear nutritional and dietary objectives (cognitive/behavioural).

4. The intensity of family involvement in treatment.

5. Stabilisation phase before ending inpatient treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 65 Years

Eligibility

Inclusion Criteria:

• All patients who accept participation between 8 and 50 years old, consecutively hospitalized for a DSM IV diagnosis of Anorexia Nervosa in one of the departments participating in this research by necessity of physical condition (BMI < 15, rapid weight loss) or psychological condition

• Parents of participating patients still living with their parents who accept participation

Exclusion Criteria:

• Refusal of research

• Patients who do not speak French

• Patients with a related somatic illness (diabetes, Crohn's disease, metabolic illness)

• Patients not covered by social security health insurance

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Other:
• inpatient treatment
Hospitalisation modalities are described but are naturalistic

Locations

Country	Name	City	State
France	Insitut Mutualiste Montsouris	Paris

Sponsors (7)

Lead Sponsor	Collaborator
Institut Mutualiste Montsouris	Caisse nationale d'assurance maladie, Fondation de France, Fondation de la Mutuelle Générale de l'Education Nationale, Institut National de la Santé Et de la Recherche Médicale, France, Ministry of Health, France, National Research Agency, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morgan and Russell score		one year follow-up	No
Secondary	Nutritional status		one year follow-up	No
Secondary	Eating disorders symptoms and diagnosis		one year follow-up	No
Secondary	Psychiatric symptoms and disorders		one year follow-up	No
Secondary	Cognitive functioning		one year follow-up	No
Secondary	Somatic symptoms and complications		one year follow-up	No
Secondary	Social adjustment		one year follow-up	No
Secondary	Quality of life		one year follow-up	No
Secondary	Family relationships		one year follow-up	No
Secondary	Re-hospitalization		one year follow-up	No