Clinical trial NCT06431854: Evaluation of a New Treatment Program for Adolescents With Eating Disorders: MINERVA Program
Official title: The Efficacy, Efficiency, and Patient Experience of a New Intensive Treatment Program for Adolescents With High-complexity Eating Disorders: MINERVA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eating Disorders in Adolescence
Anorexia Nervosa
Bulimia Nervosa
Binge-Eating Disorder
Other Specified Feeding or Eating Disorder
Keywords: Eating Disorders
Adolescence
Inpatient treatment
Home treatment
Cognitive Behaviorial Therapy
Family-Based Treatment
Dialectical Behavioral Therapy
Systemic Family Treatment
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: University Ramon Llull
First posted: 2024-05-29
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study will compare prospective data with retrospective data of patients that followed Treatment As Usual (TAU). Treatment As Usual (TAU) involves arranging visits for external consultations, partial hospitalization, and inpatient admissions as necessary, by following clinical guidelines. The retrospective control group consists of 60 patients, matched in age, sex, Body Mass Index (BMI), and diagnosis of eating disorder (ED) with the prospective group. Subjects are identified by reviewing medical records of patients treated at the ED unit of Hospital Sant Joan de Déu before the initiation of the MINERVA program. The temporal reference is the first day of admission to acute total hospitalization. Subjects present the same criteria of poor treatment response as the prospective group, ensuring severity comparability with the prospective group. Exclusion occurs if there is ≥20% missing data.
Primary purpose: TREATMENT

Brief 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

Detailed description: 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

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

Primary outcomes:
measure: O1: Changes in BMI (efficacy)
timeFrame: Up to 20 weeks
measure: O2: Changes in clinical eating symptomatology (efficacy)
timeFrame: Up to 20 weeks
measure: O3: Changes in functionality of the patient (efficacy)
timeFrame: Up to 20 weeks
measure: O4: Changes in recovery rates (efficacy)
timeFrame: 6 months after treatment completion
measure: O5: Percentage of patients in low-intensity care settings (efficiency)
timeFrame: 6 months after treatment completion
measure: Percentages of readmissions (efficiency)
timeFrame: 6 months after treatment completion
measure: Percentages of readmissions (efficiency)
timeFrame: 12 months after treatment completion
measure: Patient experience
timeFrame: Up to 20 weeks
Secondary outcomes:
measure: Changes in symptoms of anxiety
timeFrame: Up to 20 weeks
measure: Changes in symptoms of depression
timeFrame: Up to 20 weeks
measure: Changes in readiness to recover
timeFrame: Up to 20 weeks
measure: Changes in caregiver skills
timeFrame: Up to 20 weeks
measure: Changes in quality of life
timeFrame: Up to 20 weeks
measure: Functionality of the patient
timeFrame: 6 months after treatment completion
measure: Functionality of the patient
timeFrame: 12 months after treatment completion
measure: Mental illness in parents
timeFrame: Up to 20 weeks
measure: Parental skills in managing eating disorders
timeFrame: Up to 20 weeks
measure: Functionality and dynamics of the family
timeFrame: Up to 20 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Déu
Study officials:
affiliation: Hospital Sant Joan de Deu
name: Eduardo Serrano-Troncoso, Dr.
role: PRINCIPAL_INVESTIGATOR
References: