Actively Recruiting

Phase Not Applicable
Age: 12Years - 17Years
All Genders
ID06431854

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

Age: 12Years - 17Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Inpatient Treatment

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)

Family Treatment Apartment

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

Home Treatment

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

Recovery within the Community

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

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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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