New treatment program for adolescents with eating disorders
The Efficacy, Efficiency, and Patient Experience of a New Intensive Treatment Program for Adolescents With High-complexity Eating Disorders: MINERVA
This study is testing a new treatment program for teenagers with serious eating disorders to see if it helps them feel better and recover over about 16 to 20 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Fundació Sant Joan de Déu Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06431854 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy, efficiency, and patient experience of a novel treatment program for adolescents suffering from high-complexity eating disorders. The program consists of four phases: inpatient treatment, family treatment apartments, home treatment, and community recovery, spanning approximately 16 to 20 weeks. A total of 60 adolescents will participate in the program, while a matched control group of 60 will be used for comparison. Key outcomes will include changes in Body Mass Index (BMI), eating disorder symptoms, functionality, and patient experiences assessed at discharge and after 6 and 12 months.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12 to 17 diagnosed with an eating disorder who have not responded well to previous treatments.
Not a fit: Patients with acute eating disorder pathology or severe biological decompensation may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve recovery outcomes and quality of life for adolescents with eating disorders.
How similar studies have performed: While similar approaches have been explored, this specific program's comprehensive multi-phase treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for the prospective experimental group:
* Patient diagnosed with an Eating Disorder (according to the DSM-5) through a semi-structured interview (K-SADS PL-5)
* Aged between 12 and 17 years old
* Both patients and parents are willing to participate in the study and sign the informed consent to accept participation
* Patient with a poor response to treatment, defined as having one of the following two conditions:
1. undergoing over a year of treatment, including partial and total hospitalization, without symptom stabilization, experiencing severe psychological distress, eating symptomatology, comorbidities, or family dysfunction during this period (clinical improvement of at least 50 on the CGAS functioning scale) OR
2. undergoing more than three admissions without symptom stabilization (clinical improvement of at least 50 on the CGAS functioning scale).
Exclusion criteria for the prospective group:
* Acute ED pathology and biological decompensation that require urgent pediatric attention or admission to an acute psychiatric ward.
Inclusion criteria for the retrospective control group:
* Aged between 12 and 17 years old
* Diagnosed with an Eating Disorder (according to the DSM-5)
* Received treatment in Sant Joan de Déu between 2012 and 2022
* Patient with a poor response to treatment, defined as having one of the following two conditions:
1. undergoing over a year of treatment, including partial or total hospitalization, without achieving stabilization of ED symptomatology (needing high-intensive treatment units i.e. not being able to follow individual treatment in external consultations) OR
2. undergoing more than three admissions without symptom stabilization once referred to partial hospitalization in less than one year, including a similar psychological state and characteristics as the first condition
Exclusion criteria for the retrospective control group:
* Missingness of 20% or more of the required data
Where this trial is running
Barcelona
- Hospital Sant Joan de Déu — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Eduardo Serrano-Troncoso, Dr. — Hospital Sant Joan de Deu
- Study coordinator: Eduardo Serrano-Troncoso, Dr.
- Email: eserrano@sjdhospitalbarcelona.org
- Phone: 0034673837093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.