Actively Recruiting
The Efficacy, Efficiency, and Patient Experience of a New Intensive Treatment Program for Adolescents With High-complexity Eating Disorders: MINERVA
Led by Fundació Sant Joan de Déu · Updated on 2024-05-29
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
F
Fundació Sant Joan de Déu
Lead Sponsor
U
University Ramon Llull
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a new intensive treatment program called the ED-MINERVA Program for adolescents aged 12 to 17 with high-complexity eating disorders. This study aims to assess the program's effectiveness, efficiency, and patient experience compared to a retrospective control group matched by age, sex, diagnosis, and symptom severity. The study also looks at long-term effects on recovery, outpatient care intensity, readmissions, and family dynamics. The ED-MINERVA Program consists of four phases over approximately 16 to 20 weeks: 1) inpatient treatment focusing on physical stabilization and motivation for change; 2) family treatment apartments where patients and families live together to develop skills and prepare for home transition; 3) home treatment to support psychological skill generalization and family empowerment; and 4) recovery within the community with gradual intervention reduction and ongoing care at specialized centers. The program incorporates family-based treatment, cognitive behavioral therapy, dialectical behavioral therapy, and systemic family therapy. Participants will be assessed on body mass index, eating disorder symptoms, functionality, recovery rates, outpatient service use, readmissions, and patient experience during treatment and at 6 and 12 months after completion. Secondary measures include anxiety, depression, readiness to recover, quality of life, caregiver skills, and family functioning. The study includes careful monitoring and follow-up to evaluate both clinical outcomes and the experiences of patients and families.
CONDITIONS
Brief Title
Evaluation of a New Treatment Program for Adolescents With Eating Disorders: MINERVA Program
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with an Eating Disorder according to DSM-5 using a semi-structured interview
- Aged between 12 and 17 years old
- Both patient and parents willing to participate and sign informed consent
- Poor response to treatment defined as either over a year of treatment including partial or total hospitalization without symptom stabilization or more than three admissions without symptom stabilization
You will not qualify if you...
- Acute eating disorder pathology requiring urgent pediatric attention or admission to an acute psychiatric ward
- Missing 20% or more of required data for retrospective control group
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive intensive inpatient treatment at the hospital's eating disorder unit focusing on physical stabilization, adequate food intake, and initial psychological support without family presence.
Weekly visits (inpatient stay)
Duration - 2 to 3 weeks
Participants and their families live together in hospital-owned apartments to intensify treatment by addressing family-related challenges and improving autonomy and decision-making.
Continuous stay with daily family therapy sessions
Duration - 8 to 9 weeks
Participants continue treatment at home to generalize skills, with support to aid integration into family, social, and school environments.
Regular home visits and therapy sessions during this period
Duration - 2 to 4 weeks
Participants transition to specialized local eating disorder centers for gradual reduction of intervention, promotion of autonomy, and continued care.
1 to 2 visits depending on local center protocols
Trial Site Locations
Total: 1 location
1
Hospital Sant Joan de Déu
Barcelona, Spain, 08950
Actively Recruiting
Research Team
E
Eduardo Serrano-Troncoso, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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