Clinical trial NCT00910169: Evaluation of Hospitalization for Anorexia Nervosa (EVALuation de l'Apport de l'HOSPITalisation Pour Anorexie Mentale : EVALHOSPITAM)
Official title: Evaluation of Hospitalization for Anorexia Nervosa: Efficacy of Treatment and Predictive Factors of Outcome.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anorexia Nervosa
Keywords: Anorexia nervosa
treatment
inpatient
efficacy
outcome
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Ministry of Health, France
name: National Research Agency, France
name: National Health Insurance Fund
name: Fondation de la Mutuelle Générale de l'Education Nationale
name: Fondation de France
First posted: 2009-05-29
Enrollment: 300
Sex: ALL
Minimum age (years): 8
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients hospitalisied in 11 tertiary centers for eating disorders in france

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Morgan and Russell score
timeFrame: one year follow-up
Secondary outcomes:
measure: Nutritional status
timeFrame: one year follow-up
measure: Eating disorders symptoms and diagnosis
timeFrame: one year follow-up
measure: Psychiatric symptoms and disorders
timeFrame: one year follow-up
measure: Cognitive functioning
timeFrame: one year follow-up
measure: Somatic symptoms and complications
timeFrame: one year follow-up
measure: Social adjustment
timeFrame: one year follow-up
measure: Quality of life
timeFrame: one year follow-up
measure: Family relationships
timeFrame: one year follow-up
measure: Re-hospitalization
timeFrame: one year follow-up
Other outcomes:
Locations:
city: Paris
country: France
facility: Insitut Mutualiste Montsouris
Study officials:
affiliation: INSERM and Institut Mutualiste Montsouris
name: Godart Nathalie, PhD
role: PRINCIPAL_INVESTIGATOR
References: