RecruitingNot Applicable

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

Spain120 participantsStarted 2023-10-23

Plain-language summary

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

Who can participate

Age range

12 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. undergoing more than three admissions without symptom stabilization (clinical improvement of at least 50 on the CGAS functioning scale).

Exclusion criteria

. 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
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

O1: Changes in BMI (efficacy)

Timeframe: Up to 20 weeks

O2: Changes in clinical eating symptomatology (efficacy)

Timeframe: Up to 20 weeks

O3: Changes in functionality of the patient (efficacy)

Timeframe: Up to 20 weeks

O4: Changes in recovery rates (efficacy)

Timeframe: 6 months after treatment completion

O5: Percentage of patients in low-intensity care settings (efficiency)

Timeframe: 6 months after treatment completion

Percentages of readmissions (efficiency)

Timeframe: 6 months after treatment completion

Percentages of readmissions (efficiency)

Timeframe: 12 months after treatment completion

Trial details

NCT IDNCT06431854

SponsorFundació Sant Joan de Déu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Eduardo Serrano-Troncoso, Dr.

0034673837093 eserrano@sjdhospitalbarcelona.org

View on ClinicalTrials.gov More Eating Disorders in Adolescence trials

Plain-language summary

Who can participate

Age range

12 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. undergoing more than three admissions without symptom stabilization (clinical improvement of at least 50 on the CGAS functioning scale).

Exclusion criteria

. 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
. 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

What they're measuring

O1: Changes in BMI (efficacy)

Timeframe: Up to 20 weeks

O2: Changes in clinical eating symptomatology (efficacy)

Timeframe: Up to 20 weeks

O3: Changes in functionality of the patient (efficacy)

Timeframe: Up to 20 weeks

O4: Changes in recovery rates (efficacy)

Timeframe: 6 months after treatment completion

O5: Percentage of patients in low-intensity care settings (efficiency)

Timeframe: 6 months after treatment completion

Percentages of readmissions (efficiency)

Timeframe: 6 months after treatment completion

Percentages of readmissions (efficiency)

Timeframe: 12 months after treatment completion