Evaluation of Hospitalization for Anorexia Nervosa (EVALuation de l'Apport de l'HOSPITalisation Pour Anorexie Mentale : EVALHOSPITAM) (EVHAN)
August 6, 2012 updated by: Institut Mutualiste Montsouris
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
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:
- Discharge weight objectives.
- The practice of a separation period.
- The use of clear nutritional and dietary objectives (cognitive/behavioural).
- The intensity of family involvement in treatment.
- Stabilisation phase before ending inpatient treatment.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France, 75014
- Insitut Mutualiste Montsouris
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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inpatient treatment
naturalistic treatment no modification: observational study
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Hospitalisation modalities are described but are naturalistic
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Morgan and Russell score
Time Frame: one year follow-up
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one year follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Nutritional status
Time Frame: one year follow-up
|
one year follow-up
|
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Eating disorders symptoms and diagnosis
Time Frame: one year follow-up
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one year follow-up
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Psychiatric symptoms and disorders
Time Frame: one year follow-up
|
one year follow-up
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Cognitive functioning
Time Frame: one year follow-up
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one year follow-up
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Somatic symptoms and complications
Time Frame: one year follow-up
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one year follow-up
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Social adjustment
Time Frame: one year follow-up
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one year follow-up
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Quality of life
Time Frame: one year follow-up
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one year follow-up
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Family relationships
Time Frame: one year follow-up
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one year follow-up
|
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Re-hospitalization
Time Frame: one year follow-up
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one year follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Godart Nathalie, PhD, INSERM and Institut Mutualiste Montsouris
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Eudract: 2007 -A01110-53
- ANR-0-JC0719-6328
- PHRC AOM 06 020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.