NCT06218472

Brief Summary

During the management of chronic illnesses, the day hospital (DH) serves as a brief and effective alternative to traditional hospitalization, offering access to multidisciplinary care. Indeed, patients can benefit from a range of therapeutic tools provided by a multidisciplinary care team while remaining in their living environment. Numerous structures exist for the management of eating disorders, but primarily for severe cases, often following hospitalization, before transitioning to outpatient care. There is no alternative for the initial management of these patients. The DH for the evaluation and early intervention in recent forms of anorexia nervosa at Maison de Solenn serves as a rapid entry point to specialized care. It allows for a thorough assessment and sustained management of eating disorders. Our hypothesis is that a multidisciplinary, intensive, and early intervention for patients with anorexia nervosa and their families in a day hospital would improve the short, medium, and long-term prognosis of the disease compared to conventional multidisciplinary outpatient care. It would also enhance the family's experience of this pathology and their coping skills.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
72mo left

Started Feb 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Feb 2024Apr 2032

First Submitted

Initial submission to the registry

January 8, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

February 19, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2032

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

January 8, 2024

Last Update Submit

January 27, 2026

Conditions

Keywords

Anorexia nervosaFamily-based treatmentDay hospitalEarly interventionParental experience

Outcome Measures

Primary Outcomes (1)

  • Occurrence of one or more clinical events

    Occurrence of one or more clinical events indicative of the progression of this disease (hospitalization, emergency room visits, major decompensation) at 1 year. Evaluate the impact of early intervention in DH on the clinical progression of the disease compared to the usual outpatient care.

    1 year after inclusion

Secondary Outcomes (6)

  • Occurrence of one or more clinical events

    5 years after inclusion

  • Conduct semi-structured qualitative interviews

    After DH termination = 12 weeks after inclusion

  • Satisfaction questionnaire CSQ-8 (Consumer satisfaction questionnaire)

    After DH termination = 12 weeks after inclusion

  • Clinical characteristics collection

    Inclusion

  • Socio-demographic characteristics collection

    Inclusion

  • +1 more secondary outcomes

Study Arms (3)

Day hospital patient

Acceptance of the DH program (DH group): scheduling of 10 to 12 sessions over 12 weeks during a program session, followed by a reassessment at the end of the program. Outpatient follow-up thereafter.

Other: Day Hospital Treatment

Outpatient

Refusal or inability to participate in the DH program: multidisciplinary follow-up "as usual" within the service (outpatient group).

Other: Multidisciplinary follow-up "as usual" within the service

Parents

Other: Conduct semi-structured qualitative interviews

Interventions

Scheduling of 12 half-day sessions per week, alternating between sessions with only the patients or involving the entire family. Close medical monitoring and multidisciplinary interventions during sessions (pediatrician, psychiatrist, dietitian, recovered former patients...).

Also known as: Family based treatment
Day hospital patient

Multidisciplinary follow-up "as usual" within the service

Outpatient

Conduct semi-structured qualitative interviews

Parents

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will include patients of any gender aged 12 to 18 years and their parents, seen in consultation for anorexia nervosa at the pedopsychiatric unit of the Cochin Hospital, Paris, France.

You may qualify if:

  • Adolescents in the age range of 12-18 years and their parents,
  • First-time consultation at the MDA for anorexia nervosa (according to DSM-5) evolving for less than 12 months,
  • Adolescents with clinical characteristics suitable for DH care.

You may not qualify if:

  • Parents and/or children who do not speak French or cannot read or write,
  • Patients who have been followed by an eating disorder specialist in the past 12 months (at the MDA or elsewhere) or previously hospitalized for anorexia nervosa,
  • Patients who have undergone family therapy in the past,
  • Patients with BMI less than 13 kg/m2 for those under 14 years old, or less than 14 kg/m2 for those over 14 years old at the initial assessment,
  • Patients with a major psychiatric comorbidity or a metabolic condition interfering with eating or its regulation,
  • Patients and families in a crisis situation requiring immediate hospitalization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maison de Solenn Maison des Adolescents, Cochin Hospital

Paris, IDF, 75014, France

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Central Study Contacts

Corinne BLANCHET, MD, PhD

CONTACT

Marie BENHAMMANI-GODARD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 23, 2024

Study Start

February 19, 2024

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

April 1, 2032

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations