Evaluation of a Day Hospital Program for Adolescents and Young Adults With Eating Disorders
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-22
SponsorFondation Santé des Étudiants de France
About this trial
This study aims to evaluate the clinical, psychological, and functional outcomes of adolescents with anorexia nervosa receiving multidisciplinary care in hospital settings. Participants are treated either in a day hospitalization program or in a full-time inpatient program, in accordance with the French national guidelines (Haute Autorité de Santé, HAS) for the management of anorexia nervosa.
The study seeks to better understand the evolution of patients' health status over time, including nutritional, psychological, and social dimensions, and to identify factors associated with treatment response. Data will be collected as part of routine clinical care without modification of the standard therapeutic management.
The results of this study may help improve clinical practices and optimize care pathways for adolescents with anorexia nervosa.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adolescents and young adults aged 12 to 22 years
Diagnosed with an eating disorder
Referred for admission to the day hospital program between October 2019 and December 2023
Provided informed consent (and parental consent for minors)
Disqualifiers
Refusal to participate
Age below 12 years or above 22 years
Trial design
Design model
Parallel
Treatments tested in this trial
Day Hospital Multidisciplinary Care
Other interventionParticipants admitted to the day hospital receive a multidisciplinary treatment program including psychiatric, medical, nutritional, and psychosocial care, delivered through structured daytime sessions without overnight stay.
Standard Care Outside Day Hospital Program
Other interventionParticipants not admitted to the day hospital program receive usual care according to standard clinical pathways outside the specialized day hospital setting.
Treatment groups
307 Participants
are divided into 2 treatment groupsGroup A: Day Hospital ProgramOther 1 intervention
Group B: Non-Admitted ParticipantsOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in Body Mass Index (BMI)
Time frame
From admission request to at least 18 months follow-upSecondary outcomes
1
Change in eating disorder psychopathology assessed by EDE-Q
Eating disorder psychopathology will be assessed using the Eating Disorder Examination Questionnaire (EDE-Q), a self-report scale ranging from 0 to 6, with higher scores indicating more severe symptoms. The assessment will be performed at admission and discharge.
Time frame
Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission2
Change in body image concerns assessed by BSQ
Body image concerns will be assessed using the Body Shape Questionnaire (BSQ), a self-report scale with higher scores indicating greater body dissatisfaction. The assessment will be performed at admission and discharge.
Time frame
Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission3
Change in anxiety and depression symptoms assessed by HADS
Anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS), which includes subscales for anxiety and depression, each ranging from 0 to 21, with higher scores indicating greater symptom severity. The assessment will be performed at admission and discharge.
Time frame
Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission4
Change in obsessive-compulsive symptoms assessed by MOCI
Obsessive-compulsive symptoms will be assessed using the Maudsley Obsessive-Compulsive Inventory (MOCI), where higher scores indicate more severe symptoms. The assessment will be performed at admission and discharge.
Time frame
Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admissionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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