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NCT Number: NCT06431854

Evaluation of a New Treatment Program for Adolescents With Eating Disorders: MINERVA Program

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

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Key information

Conditions

Eating Disorders in Adolescence Anorexia Nervosa Binge-Eating Disorder Bulimia Nervosa Feeding and Eating Disorders Mental Disorders Other Specified Feeding or Eating Disorder Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sant Joan de Déu

Barcelona, 08950, Spain

Location status: Recruiting

Location contact

Eduardo Serrano-Troncoso, Dr.

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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).

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:
  • 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

Exclusion criteria

for the retrospective control group:

  • Missingness of 20% or more of the required data

Treatment and study plan

ED-MINERVA Program

Behavioral

ED-MINERVA Program aims to improve ED symptoms and related difficulties of the patient and provide tools to enhance the family's management (nutritionally, emotionally, and behaviorally) in their natural environment. The treatment consists of four phases with a gradually decreasing therapeutic intensity, ranging from total hospitalization, family treatment apartment, to home treatment and subsequent linkage with specialized local facilities. The ED-MINERVA program uses various aspects of family-based treatment, cognitive behavioral therapy, dialectical behavioral therapy, and systemic family therapy.

Primary outcomes

  1. O1: Changes in BMI (efficacy)

    Time frame: Up to 20 weeks

    Evaluate the change in BMI between the beginning and the end of the intervention of the patients included in the MINERVA program. Furthermore, BMI changes of the MINERVA group will be compared with retrospective data. Weight in kilograms and height in meters will be combined to report BMI in kg/m^2. Improvements in O1 and O2 need to be detected to consider the MINERVA program effective. Additionally, improvements in at least one of the other two outcomes (O3 and/or O4) need to be detected to conclude that the MINERVA program is effective at clinical and functional levels, in comparison to previous treatment programs.

  2. O2: Changes in clinical eating symptomatology (efficacy)

    Time frame: Up to 20 weeks

    Evaluate the changes in clinical eating symptomatology between the beginning and the end of the intervention of patients included in the MINERVA program. The Eating Disorder Inventory 3 (EDI-3) will be used to assess clinical eating symptomatology. It comprises 91 items where responses are given on a Likert scale (0-4). The subscales regarding 'drive for thinness' and 'body dissatisfaction' will be used for the main objective, where improvements in both subscales need to be detected. Improvements in O1 and O2 need to be detected to consider the MINERVA program effective. Additionally, improvements in at least one of the other two outcomes (O3 and/or O4) need to be detected to conclude that the MINERVA program is effective at clinical and functional levels, in comparison to previous treatment programs.

  3. O3: Changes in functionality of the patient (efficacy)

    Time frame: Up to 20 weeks

    Evaluate the functionality of the patient between the beginning and the end of the intervention in patients included in the MINERVA program. Functionally will also be assessed at 6 and 12 months after completing the program. The Children's Global Assessment Scale (CGAS) will be used to assess functionality. CGAS is scored on a range from 1 to 100, whereby a higher score indicates a better outcome. Improvements in O1 and O2 need to be detected to consider the MINERVA program effective. Additionally, improvements in at least one of the other two outcomes (O3 and/or O4) need to be detected to conclude that the MINERVA program is effective at clinical and functional levels, in comparison to previous treatment programs.

  4. O4: Changes in recovery rates (efficacy)

    Time frame: 6 months after treatment completion

    Evaluate the percentage of patients who do no longer meet diagnostics criteria for a primary eating disorder. Furthermore, data will be compared with retrospective data. Improvements in O1 and O2 need to be detected to consider the MINERVA program effective. Additionally, improvements in at least one of the other two outcomes (O3 and/or O4) need to be detected to conclude that the MINERVA program is effective at clinical and functional levels, in comparison to previous treatment programs.

  5. O5: Percentage of patients in low-intensity care settings (efficiency)

    Time frame: 6 months after treatment completion

    Determine the percentage of patients in low-intensity care settings after 6 months of completing the program (including day hospital and specific outpatient consultations). The MINERVA program will be considered efficient if more than 60% of the patients will be able to continue treatment at low-intensity outpatient services (including day hospitals and specific external consultations) in ED units or community resources.

  6. Percentages of readmissions (efficiency)

    Time frame: 6 months after treatment completion

    Determine the percentage of readmissions at 6 and 12 months after completing the program. Furthermore, this data will be compared with retrospective data. The MINERVA program will be considered efficient if more than 60% of the patients will be able to continue treatment at low-intensity outpatient services (including day hospitals and specific external consultations) in ED units. Furthermore, the program will be considered more efficient than TAU if significant lower readmission percentages in O6 and O7 will be detected.

  7. Percentages of readmissions (efficiency)

    Time frame: 12 months after treatment completion

    Determine the percentage of readmissions at 6 and 12 months after completing the program. Furthermore, this data will be compared with retrospective data. The MINERVA program will be considered efficient if more than 60% of the patients will be able to continue treatment at low-intensity outpatient services (including day hospitals and specific external consultations) in ED units. Furthermore, the program will be considered more efficient than TAU if significant lower readmission percentages in O6 and O7 will be detected.

  8. Patient experience

    Time frame: Up to 20 weeks

    Evaluate the level of satisfaction with the received intervention, adherence, and the rate of patient and family dropout (less than 20%). Patient Experience will be assessed through individual interviews with the patient and their family, and Patient-Reported Experience Measures (PREMs) surveys. PREM is a systematic online survey that assesses and describes the experience regarding healthcare services. The survey consists of Likert-scale and open-ended questions to gather narrative information that enriches qualitative data with more details and context.

Secondary outcomes

  1. Changes in symptoms of anxiety

    Time frame: Up to 20 weeks

    Evaluate changes in symptoms of anxiety between the beginning and the end of the intervention of the patients included in the MINERVA program. The State-Trait Anxiety Inventory (STAI) will be used to assess anxiety. STAI is scored on a range from 20 to 80, whereby a higher score indicates a worse outcome.

  2. Changes in symptoms of depression

    Time frame: Up to 20 weeks

    Evaluate changes in symptoms of depression between the beginning and the end of the intervention of the patients included in the MINERVA program. The Beck Depression Inventory (BDI) will be used to assess depression. It consists of 21 Likert-scale items, ranging from 0 to 3, with a cutoff point of 13 or higher that indicates the presence of depressive symptoms.

  3. Changes in readiness to recover

    Time frame: Up to 20 weeks

    Evaluate changes in readiness to recover between the beginning and the end of the intervention of the patients included in the MINERVA program. The Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ) will be used to assess motivation of recovering. It consist of 20 Likert-scale items, ranging from 1 to 5, whereby a higher score indicates a better outcome.

  4. Changes in caregiver skills

    Time frame: Up to 20 weeks

    Assess caregiver skill changes in the families of the included patients. The Caregiver Skills (CASK) will be used to assess caregiver skills. CASK is scored on a range from 0 to 100, whereby a higher outcome indicates a better outcome.

  5. Changes in quality of life

    Time frame: Up to 20 weeks

    Examine changes in the quality of life of the patients and their families. The Kidscreen-27: Quality of Life Inventory will be used to assess the quality of life. It consists of 27 Likert-scale items, ranging from 1 to 5, whereby a higher score indicates a better outcome.

  6. Functionality of the patient

    Time frame: 6 months after treatment completion

    Evaluate the functionality of the patient between the beginning and the end of the intervention in patients included in the MINERVA program. Functionally will also be assessed at 6 and 12 months after completing the program. The Children's Global Assessment Scale (CGAS) will be used to assess functionality. CGAS is scored on a range from 1 to 100, whereby a higher score indicates a better outcome.

  7. Functionality of the patient

    Time frame: 12 months after treatment completion

    Evaluate the functionality of the patient between the beginning and the end of the intervention in patients included in the MINERVA program. Functionally will also be assessed at 6 and 12 months after completing the program. The Children's Global Assessment Scale (CGAS) will be used to assess functionality. CGAS is scored on a range from 1 to 100, whereby a higher score indicates a better outcome.

  8. Mental illness in parents

    Time frame: Up to 20 weeks

    Mental illness in parents will be assessed at the beginning and the end of the intervention. The Kiddie Schedule For Affective Disorders and Schizophrenia-Present and Lifetime 5 (K-SADS-PL-5) will be used to assess mental illness in parents. The K-SADS-PL-5 is a semi-structured diagnostic interview designed to clinically diagnose ED and identify psychiatric comorbidities. It includes an introductory interview, a screening interview, and diagnostic supplements.

  9. Parental skills in managing eating disorders

    Time frame: Up to 20 weeks

    Skills in managing eating disorders of the parents will be assessed at the beginning and the end of the intervention. The Caregiver Skills (CASK) will be used to assess caregiver skills. CASK is scored on a range from 0 to 100, whereby a higher score indicates a better outcome.

  10. Functionality and dynamics of the family

    Time frame: Up to 20 weeks

    The functionality and dynamics of the family will be assessed at the beginning and the end of the intervention. The SCORE-15 will be used to assess changes in functionality and dynamics. SCORE-15 is a self-administered questionnaire that consists of 15 Likert-type items (1-5) and is divided into three scales: strengths and adaptability, concerns or distress, and communication difficulties. The total score can be on a range from 15 to 75, whereby a higher score indicates a worse outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Eduardo Serrano-Troncoso, Dr.

CONTACT

[email protected]

0034673837093

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Collaborators

  • University Ramon Llull

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 29, 2024
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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