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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• 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).

• 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

Locations
Other Locations
Spain
Hospital Sant Joan de Déu
RECRUITING
Barcelona
Contact Information
Primary
Eduardo Serrano-Troncoso, Dr.
eserrano@sjdhospitalbarcelona.org
0034673837093
Time Frame
Start Date: 2023-10-23
Estimated Completion Date: 2026-12
Participants
Target number of participants: 120
Treatments
Experimental: Patient group
This group comprises 60 patients aged 12 to 17 diagnosed with an eating disorder. They must have shown poor response to treatment, defined as having one of the two conditions: 1) undergoing over a year of treatment, including partial and total hospitalization, without symptom stabilization (needing high-intensive treatment units i.e. not being able to follow individual treatment in external consultations); 2) having more than three admissions without symptom stabilization in less than one year. They will be recruited from child/adolescent ED units in Catalonia. Exclusions will be acute ED pathology requiring urgent pediatric attention or admission to an acute psychiatric ward.
Related Therapeutic Areas
Sponsors
Collaborators: University Ramon Llull
Leads: Fundació Sant Joan de Déu

This content was sourced from clinicaltrials.gov