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Search / Trial NCT06431854

Evaluation of a New Treatment Program for Adolescents With Eating Disorders: MINERVA Program

Launched by FUNDACIÓ SANT JOAN DE DÉU · May 21, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Eating Disorders Adolescence Inpatient Treatment Home Treatment Cognitive Behaviorial Therapy Family Based Treatment Dialectical Behavioral Therapy Systemic Family Treatment

ClinConnect Summary

The MINERVA Program is a clinical trial designed to evaluate a new treatment approach for adolescents struggling with eating disorders, such as anorexia nervosa, bulimia nervosa, and binge-eating disorder. The study will involve 60 young participants, aged 12 to 17, who have not responded well to previous treatments. They will go through a four-phase program that includes inpatient treatment, family support, home care, and community recovery. The trial will also compare these participants to another group of 60 adolescents who received treatment in the past, looking at factors like weight, eating disorder symptoms, recovery status, and overall patient experience over time.

To be eligible for the trial, participants must have a diagnosed eating disorder and have faced challenges in getting better despite receiving treatment. Both the young patients and their parents need to agree to participate by signing consent forms. Throughout the study, researchers will assess various aspects of the participants’ health and well-being, including their mental health and family dynamics, to understand how effective this new treatment program is. This trial is currently recruiting participants, and it aims to provide valuable insights into better care for adolescents with eating disorders.

Gender

ALL

Eligibility 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

About Fundació Sant Joan De Déu

Fundació Sant Joan de Déu is a distinguished clinical trial sponsor dedicated to advancing medical research and improving patient care. Affiliated with the renowned Sant Joan de Déu Hospital in Barcelona, the foundation focuses on innovative healthcare solutions, fostering collaboration among healthcare professionals, researchers, and institutions. With a commitment to ethical practices and patient-centered approaches, Fundació Sant Joan de Déu supports a diverse range of clinical studies aimed at addressing complex health challenges and enhancing therapeutic outcomes. Through its comprehensive research programs, the foundation strives to contribute significantly to the field of medicine and the well-being of communities.

Locations

Barcelona, , Spain

Patients applied

0 patients applied

Trial Officials

Eduardo Serrano-Troncoso, Dr.

Principal Investigator

Hospital Sant Joan de Deu

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported