Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431854
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-04-12
Brief Title:
Evaluation of a New Treatment Program for Adolescents With Eating Disorders MINERVA Program
Sponsor:
Fundació Sant Joan de Déu
Organization:
Fundació Sant Joan de Déu
Study Overview
Official Title:
The Efficacy Efficiency and Patient Experience of a New Intensive Treatment Program for Adolescents With High-complexity Eating Disorders MINERVA
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 N60 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 N60 that matched the prospective group in age sex ED diagnosis and severe symptomatology Primary variables regarding Body Mass Index BMI ED symptomatology functionality recovery yesno type of outpatient services lowmidhigh 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None