Clinical Trials in Spain / NCT06431854
Recruiting
Not applicable
Evaluation of a New Treatment Program for Adolescents With Eating Disorders: MINERVA Program
NCT06431854 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Eating Disorders in AdolescenceAnorexia NervosaBulimia NervosaBinge-Eating DisorderOther Specified Feeding or Eating Disorder
Investigational drug(s) / intervention(s)
ED-MINERVA Program
ED-MINERVA Program: ED-MINERVA Program aims to improve ED symptoms and related difficulties of the patient and provide tools to enhance the family's management (nutritionally, emotionally, and behaviorally) in their natural environment. The treatment consists of four phases with a gradually decreasing therapeutic intensity, ranging from total hospitalization, family treatment apartment, to home treatment and subsequent linkage with specialized local facilities. The ED-MINERVA program uses various aspects of family-based treatment, cognitive behavioral therapy, dialectical behavioral therapy, and systemic family therapy.
Study 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
Eligibility
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
Primary outcome measure(s)
- O1: Changes in BMI (efficacy) — Up to 20 weeks
Evaluate the change in BMI between the beginning and the end of the intervention of the patients included in the MINERVA program. Furthermore, BMI changes of the MINERVA group will be compared with retrospective data. Weight in kilograms and height in meters will be combined to report BMI in kg/m\^2. Improvements in O1 and O2 need to be detected to consider the MINERVA program effective. Additionally, improvements in at least one of the other two outcomes (O3 and/or O4) need to be detected to conclude that the MINERVA program is effective at clinical and functional levels, in comparison to previous treatment programs. - O2: Changes in clinical eating symptomatology (efficacy) — Up to 20 weeks
Evaluate the changes in clinical eating symptomatology between the beginning and the end of the intervention of patients included in the MINERVA program. The Eating Disorder Inventory 3 (EDI-3) will be used to assess clinical eating symptomatology. It comprises 91 items where responses are given on a Likert scale (0-4). The subscales regarding 'drive for thinness' and 'body dissatisfaction' will be used for the main objective, where improvements in both subscales need to be detected. Improvements in O1 and O2 need to be detected to consider the MINERVA program effective. Additionally, improvements in at least one of the other two outcomes (O3 and/or O4) need to be detected to conclude that the MINERVA program is effective at clinical and functional levels, in comparison to previous treatment programs. - O3: Changes in functionality of the patient (efficacy) — Up to 20 weeks
Evaluate the functionality of the patient between the beginning and the end of the intervention in patients included in the MINERVA program. Functionally will also be assessed at 6 and 12 months after completing the program. The Children's Global Assessment Scale (CGAS) will be used to assess functionality. CGAS is scored on a range from 1 to 100, whereby a higher score indicates a better outcome. Improvements in O1 and O2 need to be detected to consider the MINERVA program effective. Additionally, improvements in at least one of the other two outcomes (O3 and/or O4) need to be detected to conclude that the MINERVA program is effective at clinical and functional levels, in comparison to previous treatment programs. - O4: Changes in recovery rates (efficacy) — 6 months after treatment completion
Evaluate the percentage of patients who do no longer meet diagnostics criteria for a primary eating disorder. Furthermore, data will be compared with retrospective data. Improvements in O1 and O2 need to be detected to consider the MINERVA program effective. Additionally, improvements in at least one of the other two outcomes (O3 and/or O4) need to be detected to conclude that the MINERVA program is effective at clinical and functional levels, in comparison to previous treatment programs. - O5: Percentage of patients in low-intensity care settings (efficiency) — 6 months after treatment completion
Determine the percentage of patients in low-intensity care settings after 6 months of completing the program (including day hospital and specific outpatient consultations). The MINERVA program will be considered efficient if more than 60% of the patients will be able to continue treatment at low-intensity outpatient services (including day hospitals and specific external consultations) in ED units or community resources. - Percentages of readmissions (efficiency) — 6 months after treatment completion
Determine the percentage of readmissions at 6 and 12 months after completing the program. Furthermore, this data will be compared with retrospective data. The MINERVA program will be considered efficient if more than 60% of the patients will be able to continue treatment at low-intensity outpatient services (including day hospitals and specific external consultations) in ED units. Furthermore, the program will be considered more efficient than TAU if significant lower readmission percentages in O6 and O7 will be detected. - Percentages of readmissions (efficiency) — 12 months after treatment completion
Determine the percentage of readmissions at 6 and 12 months after completing the program. Furthermore, this data will be compared with retrospective data. The MINERVA program will be considered efficient if more than 60% of the patients will be able to continue treatment at low-intensity outpatient services (including day hospitals and specific external consultations) in ED units. Furthermore, the program will be considered more efficient than TAU if significant lower readmission percentages in O6 and O7 will be detected. - Patient experience — Up to 20 weeks
Evaluate the level of satisfaction with the received intervention, adherence, and the rate of patient and family dropout (less than 20%). Patient Experience will be assessed through individual interviews with the patient and their family, and Patient-Reported Experience Measures (PREMs) surveys. PREM is a systematic online survey that assesses and describes the experience regarding healthcare services. The survey consists of Likert-scale and open-ended questions to gather narrative information that enriches qualitative data with more details and context.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital Sant Joan de Déu | Barcelona | Spain | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06431854 on ClinicalTrials.gov ↗ ← All trials in Spain