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

Официальное название

The Efficacy, Efficiency, and Patient Experience of a New Intensive Treatment Program for Adolescents With High-complexity Eating Disorders: MINERVA

Обзор

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

Подробное описание

The goal of this single-center, longitudinal study is to test the efficacy, efficiency, and patient experience of a new intensive treatment program in adolescents with high-complex eating disorders. The main questions it aims to answer are:

* What are the efficacy, efficiency, and patient experiences (families and patients) of the new treatment program in adolescents with high-complex eating disorders? * What are the long-term effects of efficacy and efficiency (after 6 and after 12 months) of the new treatment program in adolescents with high-complex eating disorders?

Participants will receive this new treatment program in four different phases between 16 and 20 weeks approximately.

* 1st: inpatient treatment (4 weeks): Set-up: inpatient ED unit at the hospital (without the family). Objectives: maintenance of physical stabilization; ensuring adequate food intake while preventing compensatory behaviors; addressing ED-related problems; improving nutritional administration; enhancing awareness of the disorder and motivating the patient to change. * 2nd: family treatment apartment (2-3 weeks): Set-up: apartments where patients and their families live together that is owned by the healthcare system provider. Family treatment apartments are within a hospital context to facilitate a good transition to home treatment.

Objectives: intensifying the treatment within a hospital setting that targets the difficulties the family encounter in managing ED symptoms; intervening from a systemic perspective; involving other family members in the treatment; collaborating with the family in developing skills to cope with the disorder; working on more autonomy and improved ED decision-making; facilitating the transition from hospitalization to home; facilitate access to the hospital staff and leads to a high frequency treatment.

* 3rd: home treatment (8-9 weeks): Set-up: Patients live in their own home. Objectives: facilitating a good transition from hospitalization and family treatment apartments to home; generalize psychological skills and learnings; assisting in the progress that began in the hospital environment; providing treatment in a more family and social context; empowering families in their natural setting; promoting integration of the patient into their family, social, and school environments. * 4th: Recovery within the community (2-4 weeks): Set-up: transferring to the patients' specialized ED reference center. Objectives: gradually reducing the intervention from MINERVA; promoting autonomy and emotional management within their family and school environment; ensuring continued care with their ED reference unit; monitoring the implemented intervention.

The current model will provide different treatment models during these phases.

* family-based treatment * cognitive behavioural therapy * dialectical behavioural therapy * systemic family therapy

Вмешательства

• Поведенческое 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-

Первичные конечные точки

• O1: Changes in BMI (efficacy) [Срок оценки: Up to 20 weeks]
• O2: Changes in clinical eating symptomatology (efficacy) [Срок оценки: Up to 20 weeks]
• O3: Changes in functionality of the patient (efficacy) [Срок оценки: Up to 20 weeks]
• O4: Changes in recovery rates (efficacy) [Срок оценки: 6 months after treatment completion]
• O5: Percentage of patients in low-intensity care settings (efficiency) [Срок оценки: 6 months after treatment completion]
• Percentages of readmissions (efficiency) [Срок оценки: 6 months after treatment completion]
• Percentages of readmissions (efficiency) [Срок оценки: 12 months after treatment completion]
• Patient experience [Срок оценки: Up to 20 weeks]

Вторичные конечные точки (10)

• Changes in symptoms of anxiety [Срок оценки: Up to 20 weeks]
• Changes in symptoms of depression [Срок оценки: Up to 20 weeks]
• Changes in readiness to recover [Срок оценки: Up to 20 weeks]
• Changes in caregiver skills [Срок оценки: Up to 20 weeks]
• Changes in quality of life [Срок оценки: Up to 20 weeks]
• Functionality of the patient [Срок оценки: 6 months after treatment completion]
• Functionality of the patient [Срок оценки: 12 months after treatment completion]
• Mental illness in parents [Срок оценки: Up to 20 weeks]
• Parental skills in managing eating disorders [Срок оценки: Up to 20 weeks]
• Functionality and dynamics of the family [Срок оценки: Up to 20 weeks]

Критерии участия

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:

• 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 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:

• 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

Exclusion criteria for the retrospective control group:

• Missingness of 20% or more of the required data

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Sant Joan de Déu — Barcelona

Идентификаторы

NCT: NCT06431854 · MINERVA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗