Overview

This trial is active, not recruiting.

Condition anorexia nervosa
Treatment inpatient treatment
Sponsor Institut Mutualiste Montsouris
Collaborator Institut National de la Santé Et de la Recherche Médicale, France
Start date March 2009
End date October 2012
Trial size 300 participants
Trial identifier NCT00910169, ANR-0-JC0719-6328, Eudract: 2007 -A01110-53, PHRC AOM 06 020

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
naturalistic treatment no modification: observational study
inpatient treatment naturalistic treatment
Hospitalisation modalities are described but are naturalistic

Primary Outcomes

Measure
Morgan and Russell score
time frame: one year follow-up

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 8 years up to 65 years old.

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

Additional Information

Official title Evaluation of Hospitalization for Anorexia Nervosa: Efficacy of Treatment and Predictive Factors of Outcome.
Principal investigator Godart Nathalie, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by Institut Mutualiste Montsouris.