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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Institut Mutualiste Montsouris.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Ministry of Health, France
National Research Agency, France
Caisse nationale d'assurance maladie
Fondation de la Mutuelle Générale de l'Education Nationale
Fondation de France
Information provided by:
Institut Mutualiste Montsouris
ClinicalTrials.gov Identifier:
NCT00910169
First received: May 26, 2009
Last updated: August 6, 2012
Last verified: May 2009
  Purpose

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).


Condition Intervention
Anorexia Nervosa
Other: inpatient treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Hospitalization for Anorexia Nervosa: Efficacy of Treatment and Predictive Factors of Outcome.

Further study details as provided by Institut Mutualiste Montsouris:

Primary Outcome Measures:
  • Morgan and Russell score [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nutritional status [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
  • Eating disorders symptoms and diagnosis [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
  • Psychiatric symptoms and disorders [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
  • Cognitive functioning [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
  • Somatic symptoms and complications [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
  • Social adjustment [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
  • Family relationships [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
  • Re-hospitalization [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

all biological analysis during hospitalisation, serotonin , tryptophan, CD4/CD8


Estimated Enrollment: 300
Study Start Date: March 2009
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
inpatient treatment
naturalistic treatment no modification: observational study
Other: inpatient treatment
Hospitalisation modalities are described but are naturalistic
Other Name: naturalistic 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.
  Eligibility

Ages Eligible for Study:   8 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910169

Locations
France
Insitut Mutualiste Montsouris
Paris, France, 75014
Sponsors and Collaborators
Institut Mutualiste Montsouris
Institut National de la Santé Et de la Recherche Médicale, France
Ministry of Health, France
National Research Agency, France
Caisse nationale d'assurance maladie
Fondation de la Mutuelle Générale de l'Education Nationale
Fondation de France
Investigators
Principal Investigator: Godart Nathalie, PhD INSERM and Institut Mutualiste Montsouris
  More Information

No publications provided

Responsible Party: Nathalie Godart, M.D., Ph.D., Institut Mutualiste Montsouris
ClinicalTrials.gov Identifier: NCT00910169     History of Changes
Other Study ID Numbers: Eudract: 2007 -A01110-53, ANR-0-JC0719-6328, PHRC AOM 06 020
Study First Received: May 26, 2009
Last Updated: August 6, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Direction Générale de la Santé
France: Institutional Ethical Committee

Keywords provided by Institut Mutualiste Montsouris:
Anorexia nervosa
treatment
inpatient
efficacy
outcome

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014