Eating DisordersVIBUS-wp1NCT05956366
Effectiveness of Family-based Intervention for Youn Persons With Eating Disorders
An observational study of Eating Disorders, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial summary
This research project aims to characterize a naturalistic cohort of children and adolescents with eating disorders in terms of biological, psychological and psychopathological features. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Family-based treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2018to 31 Dec 2037
- Phase
- Observational
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: All patients assessed and treated for any eating disorder (ICD-10: F50.0-F50.8) in the unit for treatment of eating disorders will be invited to participate. Due to the naturalistic design of this study we will examine a representative, consecutive sample, without any exclusion criteria except the absence of informed consent by patient and parents or legal care takers.
Who may be able to join
- begin treatment for eating disorder
Who cannot join
- lack of informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Child and Adolescent Mental Health Care Center
Copenhagen, DK-2400
Mette Bentz, PhD, +45 38 64 10 35, mette.bentz@regionh.dk
About this study
Official title: Effectiveness of Family-based Intervention in a Child and Adolescent Mental Health Service for Children and Adolescents With Eating Disorders
This research project aims to characterize a naturalistic cohort of children and adolescents with eating disorders in terms of biological, psychological and psychopathological features. Further, the project will examine the effectiveness of treatment, the determinants of treatment outcome and the course of treatment response for children and adolescents with eating disorders (ED), treated in a generic specialist child and adolescent mental health service. The first choice of treatment is outpatient family-based treatment (FBT), which has documented effect for anorexia nervosa and bulimia nervosa. However, a subgroup of young persons with eating disorders does not respond sufficiently to this treatment, and evidence concerning effective treatment for children and adolescents with atypical eating disorders is still lacking. Further, treatment effectiveness for children and adolescents in a Danish naturalistic setting has never been examined.
Read the detailed description
The overall aim is to assess associations between patient characteristics and treatment response across the spectrum of eating disorders to identify, which patients benefit from family based treatment, and which patients possibly would need other kinds of treatment or more intensive care.
Research questions:
- Which patient and family characteristics predict faster recovery from ED in childhood and adolescence?
- Which patient and family characteristics predict intensification of treatment in the forms of day hospital or full hospitalization?
- At which time point can recovery be predicted based on information from initial assessment and/or assessment during the course of treatment?
- Which patient and family characteristics (e.g. patterns of comorbid symptoms) are common in those not responding well to treatment within each diagnostic category?
- How many young patients migrate between ED diagnoses, and what characterizes these patients?
- Studies on treatment effectiveness for EDNOS in children and adolescents are still lacking. Hence, an important research question of this study is whether family based treatment for EDNOS is effective and is perceived as helpful by patients and families? In addition, the project will seek to answer the following:
- Is treatment effectiveness in The Capital Region of Denmark (BUC) comparable to published results from other countries in the same age group?
- Conditions
- Eating Disorders
- Being tested
- Family-based treatment
- Keywords
- eating disorders, adolescents
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based treatmentBehavioural
Also called FBT
Open-end family therapy ad modum The Maudsley model
| Study group | Role | What they receive |
|---|---|---|
| Anorexia nervosa | Children and adolescents presenting for treatment for anorexia nervosa typica or atypica (ICD-10: F50.0 or F50.1) Receives: Behavioral: Family-based treatment | |
| Bulimia nervosa | Children and adolescents presenting for treatment for bulimia nervosa typica or atypica (ICD-10: F50.2 or F50.3) Receives: Behavioral: Family-based treatment | |
| Other eating disorders | Children and adolescents presenting for treatment for other eating disorders (ICD-10: F50.8) Receives: Behavioral: Family-based treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of participants with weight normalisation
at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents
Measured: through treatment completion an average of 1 year
proportion of participants with weight normalisation
at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents
Measured: 2.5 years after treatment completion
proportion of participants with weight normalisation
at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents
Measured: 5 years after treatment completion
proportion of participants with weight normalisation
at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents
Measured: 7.5 years after treatment completion
proportion of participants with weight normalisation
at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents
Measured: 10 years after treatment completion
proportion of participants with absence of eating disordered behaviors
absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).
Measured: through treatment completion an average of 1 year
proportion of participants with absence of eating disordered behaviors
absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).
Measured: 2.5 years after treatment completion
proportion of participants with absence of eating disordered behaviors
absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).
Measured: 5 years after treatment completion
proportion of participants with absence of eating disordered behaviors
absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).
Measured: 7.5 years after treatment completion
proportion of participants with absence of eating disordered behaviors
absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).
Measured: 10 years after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 Apr 2018
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mette Bentz, PhD, Principal investigator, Child and Adolescent Mental Health Care Centre, Capital Region of DenmarkAnne Katrine Pagsberg, professor, Study director, Child and Adolescent Mental Health Care Centre, Capital Region of Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956366
- Sponsor's protocol ID
- H-17022391
- Acronym
- VIBUS-wp1
- Status last verified
- Mar 2024
- First submitted
- 2 Feb 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bentz M, Pedersen SH, Moslet U, Petersen N, Pagsberg AK. Predictors of response to family-based treatment for anorexia nervosa in youth: insights from the VIBUS project. Eur Child Adolesc Psychiatry. 2025 Nov;34(11):3665-3684. doi: 10.1007/s00787-025-02766-x. Epub 2025 Jun 11.
PubMed 40498327
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Family-based Intervention in a Child and Adolescent Mental Health Service for Children and Adolescents With Eating Disorders
- ClinicalTrials.gov ID
- NCT05956366
- Acronym / sponsor ID
- VIBUS-wp1 / H-17022391
- Conditions
- Eating Disorders
- Keywords
- eating disorders, adolescents
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 21 Jul 2023 (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.
This research project aims to characterize a naturalistic cohort of children and adolescents with eating disorders in terms of biological, psychological and psychopathological features. Further, the project will examine the effectiveness of treatment, the determinants of treatment outcome and the course of treatment response for children and adolescents with eating disorders (ED), treated in a generic specialist child and adolescent mental health service. The first choice of treatment is outpatient family-based treatment (FBT), which has documented effect for anorexia nervosa and bulimia nervosa. However, a subgroup of young persons with eating disorders does not respond sufficiently to this treatment, and evidence concerning effective treatment for children and adolescents with atypical eating disorders is still lacking. Further, treatment effectiveness for children and adolescents in a Danish naturalistic setting has never been examined.
Detailed description
The overall aim is to assess associations between patient characteristics and treatment response across the spectrum of eating disorders to identify, which patients benefit from family based treatment, and which patients possibly would need other kinds of treatment or more intensive care.
Research questions:
- Which patient and family characteristics predict faster recovery from ED in childhood and adolescence?
- Which patient and family characteristics predict intensification of treatment in the forms of day hospital or full hospitalization?
- At which time point can recovery be predicted based on information from initial assessment and/or assessment during the course of treatment?
- Which patient and family characteristics (e.g. patterns of comorbid symptoms) are common in those not responding well to treatment within each diagnostic category?
- How many young patients migrate between ED diagnoses, and what characterizes these patients?
- Studies on treatment effectiveness for EDNOS in children and adolescents are still lacking. Hence, an important research question of this study is whether family based treatment for EDNOS is effective and is perceived as helpful by patients and families? In addition, the project will seek to answer the following:
- Is treatment effectiveness in The Capital Region of Denmark (BUC) comparable to published results from other countries in the same age group?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anorexia nervosa | – | Behavioral: Family-based treatmentChildren and adolescents presenting for treatment for anorexia nervosa typica or atypica (ICD-10: F50.0 or F50.1) |
| Bulimia nervosa | – | Behavioral: Family-based treatmentChildren and adolescents presenting for treatment for bulimia nervosa typica or atypica (ICD-10: F50.2 or F50.3) |
| Other eating disorders | – | Behavioral: Family-based treatmentChildren and adolescents presenting for treatment for other eating disorders (ICD-10: F50.8) |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All patients assessed and treated for any eating disorder (ICD-10: F50.0-F50.8) in the unit for treatment of eating disorders will be invited to participate. Due to the naturalistic design of this study we will examine a representative, consecutive sample, without any exclusion criteria except the absence of informed consent by patient and parents or legal care takers.
Key inclusion criteria (1 listed)
- begin treatment for eating disorder
Key exclusion criteria (1 listed)
- lack of informed consent
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 |
|---|---|---|
| Family-based treatmentAlso: FBTOpen-end family therapy ad modum The Maudsley model | Behavioural | Anorexia nervosa, Bulimia nervosa, Other eating disorders |
Primary outcome
proportion of participants with weight normalisation
Time frame: through treatment completion an average of 1 year
at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents
proportion of participants with weight normalisation
Time frame: 2.5 years after treatment completion
at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents
proportion of participants with weight normalisation
Time frame: 5 years after treatment completion
at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents
proportion of participants with weight normalisation
Time frame: 7.5 years after treatment completion
at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents
proportion of participants with weight normalisation
Time frame: 10 years after treatment completion
at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents
proportion of participants with absence of eating disordered behaviors
Time frame: through treatment completion an average of 1 year
absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).
proportion of participants with absence of eating disordered behaviors
Time frame: 2.5 years after treatment completion
absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).
proportion of participants with absence of eating disordered behaviors
Time frame: 5 years after treatment completion
absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).
proportion of participants with absence of eating disordered behaviors
Time frame: 7.5 years after treatment completion
absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).
proportion of participants with absence of eating disordered behaviors
Time frame: 10 years after treatment completion
absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).
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 3 Apr 2024.
- Derived from this study: PubMed 40498327Bentz M, Pedersen SH, Moslet U, Petersen N, Pagsberg AK. Predictors of response to family-based treatment for anorexia nervosa in youth: insights from the VIBUS project. Eur Child Adolesc Psychiatry. 2025 Nov;34(11):3665-3684. doi: 10.1007/s00787-025-02766-x. Epub 2025 Jun 11.
- Individual participant dataSharing planned: No
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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.
Mette Bentz, PhD principal investigator
Child and Adolescent Mental Health Care Centre, Capital Region of Denmark
Anne Katrine Pagsberg, professor study director
Child and Adolescent Mental Health Care Centre, Capital Region of Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorders, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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 1 inclusion and 1 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 3 Apr 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 Denmark. 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 Mette Bentz, PhD (+45 38 64 10 35, mette.bentz@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of participants with weight normalisation (time frame: through treatment completion an average of 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05956366, which also lists 1 linked publication.
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 3 Apr 2024.