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

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

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).

Study Overview

• Status: Unknown
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Other: inpatient treatment

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Insitut Mutualiste Montsouris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients hospitalisied in 11 tertiary centers for eating disorders in france

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
inpatient treatment; naturalistic treatment no modification: observational study	Other: inpatient treatment; Hospitalisation modalities are described but are naturalistic; Other Names: naturalistic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Morgan and Russell score	one year follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Nutritional status	one year follow-up
Eating disorders symptoms and diagnosis	one year follow-up
Psychiatric symptoms and disorders	one year follow-up
Cognitive functioning	one year follow-up
Somatic symptoms and complications	one year follow-up
Social adjustment	one year follow-up
Quality of life	one year follow-up
Family relationships	one year follow-up
Re-hospitalization	one year follow-up

Collaborators and Investigators

• Sponsor: Institut Mutualiste Montsouris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Ministry of Health, France; National Research Agency, France; Fondation de France; National Health Insurance Fund; Fondation de la Mutuelle Générale de l'Education Nationale
• Investigators: Principal Investigator: Godart Nathalie, PhD, INSERM and Institut Mutualiste Montsouris

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Anticipated): October 1, 2012
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: May 26, 2009
• First Submitted That Met QC Criteria: May 28, 2009
• First Posted (Estimate): May 29, 2009

Study Record Updates

• Last Update Posted (Estimate): August 7, 2012
• Last Update Submitted That Met QC Criteria: August 6, 2012
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: treatment; outcome; efficacy; inpatient; Anorexia nervosa
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: Eudract: 2007 -A01110-53; ANR-0-JC0719-6328; PHRC AOM 06 020