- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07648108
Evaluation of a Day Hospital Program for Adolescents and Young Adults With Eating Disorders (UDJ-TCA)
Evaluation of the Contribution of a Specialized Day Hospital for Adolescents and Young Adults With Eating Disorders: Long-Term Clinical Outcomes and Cross-Reported Experiences
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Refusal to participate
- Age below 12 years or above 22 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Day Hospital Program
Participants admitted to a specialized multidisciplinary day hospital program for eating disorders.
|
Participants 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.
|
|
Other: Non-Admitted Participants
Participants who requested admission but were not admitted to the day hospital program.
|
Participants not admitted to the day hospital program receive usual care according to standard clinical pathways outside the specialized day hospital setting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Body Mass Index (BMI)
Time Frame: From admission request to at least 18 months follow-up
|
From admission request to at least 18 months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in eating disorder psychopathology assessed by EDE-Q
Time Frame: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
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.
|
Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
|
Change in body image concerns assessed by BSQ
Time Frame: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
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.
|
Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
|
Change in anxiety and depression symptoms assessed by HADS
Time Frame: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
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.
|
Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
|
Change in obsessive-compulsive symptoms assessed by MOCI
Time Frame: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
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.
|
Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
|
Change in eating disorder-related quality of life assessed by EDQoL
Time Frame: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
Quality of life related to eating disorders will be assessed using the Eating Disorders Quality of Life (EDQoL) questionnaire, with higher scores indicating greater impairment.
The assessment will be performed at admission and discharge
|
Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
|
Change in autistic traits assessed by AQ-10
Time Frame: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
Autistic traits will be assessed using the Autism Spectrum Quotient (AQ-10), a brief screening tool with higher scores indicating more pronounced autistic traits.
The assessment will be performed at admission and discharge
|
Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
|
Change in family functioning assessed by FAD-12
Time Frame: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
Family functioning will be assessed using the Family Assessment Device (FAD-12), with higher scores indicating poorer family functioning.
The assessment will be performed at admission and discharge.
|
Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-A02535-42
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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