Actively Recruiting

Phase Not Applicable
Age: 12Years - 17Years
All Genders
NCT06431854

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

Led by Fundació Sant Joan de Déu · Updated on 2024-05-29

120

Participants Needed

1

Research Sites

162 weeks

Total Duration

On this page

Sponsors

F

Fundació Sant Joan de Déu

Lead Sponsor

U

University Ramon Llull

Collaborating Sponsor

AI-Summary

What this Trial Is About

The aim of this study is to investigate the efficacy, efficiency, and patient experience of a new intervention program on adolescents with high-complexity eating disorders (ED). A prospective group of adolescents with ED (N=60) will follow this treatment program including four different phases: 1) Inpatient treatment; 2) Family Treatment Apartment; 3) Home Treatment; 4) Recovery within the community. The investigators will use a retrospective, control group (N=60) that matched the prospective group in age, sex, ED diagnosis, and severe symptomatology. Primary variables regarding Body Mass Index (BMI), ED symptomatology, functionality, recovery (yes/no), type of outpatient services (low/mid/high intensity), number of readmissions, and patient experience will be assessed at discharge, and after 6 and 12 months. Secondary variables include anxiety, depression, readiness to recover, quality of life symptoms, caregiver skills, and functionality of the family

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
  • Aged between 12 and 17 years old (retrospective control group)
  • Diagnosed with an Eating Disorder (according to the DSM-5) (retrospective control group)
  • Received treatment in Sant Joan de Déu between 2012 and 2022 (retrospective control group)
  • 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 (retrospective control group)
Not Eligible

You will not qualify if you...

  • Acute ED pathology and biological decompensation that require urgent pediatric attention or admission to an acute psychiatric ward (prospective group)
  • Missingness of 20% or more of the required data (retrospective control group)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hospital Sant Joan de Déu

Barcelona, Spain, 08950

Actively Recruiting

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Research Team

E

Eduardo Serrano-Troncoso, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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