Eating Disorders in AdolescenceNCT06431854
Evaluation of a New Treatment Program for Adolescents With Eating Disorders: MINERVA Program
A study testing ED-MINERVA Program in people with Eating Disorders in Adolescence and Anorexia Nervosa, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Eating Disorders in Adolescence, Anorexia Nervosa, Bulimia Nervosa
- What is being tested?
- ED-MINERVA Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 23 Oct 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Show all 12Show fewer
- 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
Who cannot join
- Acute ED pathology and biological decompensation that require urgent pediatric attention or admission to an acute psychiatric ward.
- Missingness of 20% or more of the required data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Sant Joan de Déu
Barcelona, 08950
Eduardo Serrano-Troncoso, Dr., eserrano@sjdhospitalbarcelona.org
About this study
Official title: The Efficacy, Efficiency, and Patient Experience of a New Intensive Treatment Program for Adolescents With High-complexity Eating Disorders: MINERVA
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
Read the 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
- Conditions
- Eating Disorders in Adolescence, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Other Specified Feeding or Eating Disorder
- Being tested
- ED-MINERVA Program
- Keywords
- Eating Disorders, Adolescence, Inpatient treatment, Home treatment, Cognitive Behaviorial Therapy, Family-Based Treatment, Dialectical Behavioral Therapy, Systemic Family Treatment
- Medical subject headings
- Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED-MINERVA ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Experimental | 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. Receives: Behavioral: ED-MINERVA Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
O1: Changes in BMI (efficacy)
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.
Measured: Up to 20 weeks
O2: Changes in clinical eating symptomatology (efficacy)
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.
Measured: Up to 20 weeks
O3: Changes in functionality of the patient (efficacy)
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.
Measured: Up to 20 weeks
O4: Changes in recovery rates (efficacy)
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.
Measured: 6 months after treatment completion
O5: Percentage of patients in low-intensity care settings (efficiency)
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.
Measured: 6 months after treatment completion
Percentages of readmissions (efficiency)
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.
Measured: 6 months after treatment completion
Percentages of readmissions (efficiency)
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.
Measured: 12 months after treatment completion
Patient experience
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.
Measured: Up to 20 weeks
Secondary outcomes (10)
Changes in symptoms of anxiety
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.
Measured: Up to 20 weeks
Changes in symptoms of depression
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.
Measured: Up to 20 weeks
Changes in readiness to recover
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.
Measured: Up to 20 weeks
Changes in caregiver skills
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.
Measured: Up to 20 weeks
Changes in quality of life
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.
Measured: Up to 20 weeks
Functionality of the patient
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.
Measured: 6 months after treatment completion
Functionality of the patient
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.
Measured: 12 months after treatment completion
Mental illness in parents
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.
Measured: Up to 20 weeks
Parental skills in managing eating disorders
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.
Measured: Up to 20 weeks
Functionality and dynamics of the family
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
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start23 Oct 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating Disorders in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will compare prospective data with retrospective data of patients that followed Treatment As Usual (TAU). Treatment As Usual (TAU) involves arranging visits for external consultations, partial hospitalization, and inpatient admissions as necessary, by following clinical guidelines. The retrospective control group consists of 60 patients, matched in age, sex, Body Mass Index (BMI), and diagnosis of eating disorder (ED) with the prospective group. Subjects are identified by reviewing medical records of patients treated at the ED unit of Hospital Sant Joan de Déu before the initiation of the MINERVA program. The temporal reference is the first day of admission to acute total hospitalization. Subjects present the same criteria of poor treatment response as the prospective group, ensuring severity comparability with the prospective group. Exclusion occurs if there is ≥20% missing data.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- University Ramon Llull
- Responsible party
- Sponsor
- Investigators
- Eduardo Serrano-Troncoso, Dr., Principal investigator, Hospital Sant Joan de Deu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431854
- Sponsor's protocol ID
- MINERVA
- Status last verified
- May 2024
- First submitted
- 12 Apr 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through the current study may be provided to qualified researchers with academic interest in eating disorders. Data shared will be encoded, with no Protected Health Information (PHI) included.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy, Efficiency, and Patient Experience of a New Intensive Treatment Program for Adolescents With High-complexity Eating Disorders: MINERVA
- ClinicalTrials.gov ID
- NCT06431854
- Acronym / sponsor ID
- MINERVA
- Conditions
- Eating Disorders in Adolescence, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Other Specified Feeding or Eating Disorder
- Keywords
- Eating Disorders, Adolescence, Inpatient treatment, Home treatment, Cognitive Behaviorial Therapy, Family-Based Treatment, Dialectical Behavioral Therapy, Systemic Family Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- University Ramon Llull
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will compare prospective data with retrospective data of patients that followed Treatment As Usual (TAU). Treatment As Usual (TAU) involves arranging visits for external consultations, partial hospitalization, and inpatient admissions as necessary, by following clinical guidelines. The retrospective control group consists of 60 patients, matched in age, sex, Body Mass Index (BMI), and diagnosis of eating disorder (ED) with the prospective group. Subjects are identified by reviewing medical records of patients treated at the ED unit of Hospital Sant Joan de Déu before the initiation of the MINERVA program. The temporal reference is the first day of admission to acute total hospitalization. Subjects present the same criteria of poor treatment response as the prospective group, ensuring severity comparability with the prospective group. Exclusion occurs if there is ≥20% missing data.
| Arm | Type | Receives |
|---|---|---|
| Patient group | Experimental | Behavioral: ED-MINERVA ProgramThis 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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:
- Aged between 12 and 17 years old
Key exclusion criteria (2 listed)
- Acute ED pathology and biological decompensation that require urgent pediatric attention or admission to an acute psychiatric ward.
- Missingness of 20% or more of the required data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ED-MINERVA ProgramED-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. | Behavioural | Patient group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
10 secondary outcomes
Changes in symptoms of anxiety
Time frame: Up to 20 weeks
Changes in symptoms of depression
Time frame: Up to 20 weeks
Changes in readiness to recover
Time frame: Up to 20 weeks
Changes in caregiver skills
Time frame: Up to 20 weeks
Changes in quality of life
Time frame: Up to 20 weeks
Functionality of the patient
Time frame: 6 months after treatment completion
Functionality of the patient
Time frame: 12 months after treatment completion
Mental illness in parents
Time frame: Up to 20 weeks
Parental skills in managing eating disorders
Time frame: Up to 20 weeks
Functionality and dynamics of the family
Time frame: Up to 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: Yes. Data obtained through the current study may be provided to qualified researchers with academic interest in eating disorders. Data shared will be encoded, with no Protected Health Information (PHI) included.
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Obesity, Binge-Eating Disorder
Recruiting
Cerebellar tDCS Stimulation in Children and Adult Women With Anorexia Nervosa Disorder
Anorexia Nervosa
Not yet recruiting
Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (Online)
Binge Eating, Overweight and Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eduardo Serrano-Troncoso, Dr. principal investigator
Hospital Sant Joan de Deu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ED-MINERVA Program in people with Eating Disorders in Adolescence and Anorexia Nervosa, run by Fundació Sant Joan de Déu at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Serrano-Troncoso, Dr. (0034673837093, eserrano@sjdhospitalbarcelona.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
O1: Changes in BMI (efficacy) (time frame: Up to 20 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.