Effectiveness of Family-based Intervention for Youn Persons With Eating Disorders

NCT ID: NCT05956366

Last Updated: 2024-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2037-12-31

Brief Summary

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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

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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:

1. Which patient and family characteristics predict faster recovery from ED in childhood and adolescence?
2. Which patient and family characteristics predict intensification of treatment in the forms of day hospital or full hospitalization?
3. At which time point can recovery be predicted based on information from initial assessment and/or assessment during the course of treatment?
4. Which patient and family characteristics (e.g. patterns of comorbid symptoms) are common in those not responding well to treatment within each diagnostic category?
5. How many young patients migrate between ED diagnoses, and what characterizes these patients?
6. 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:
7. Is treatment effectiveness in The Capital Region of Denmark (BUC) comparable to published results from other countries in the same age group?

Conditions

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Eating Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Anorexia nervosa

Children and adolescents presenting for treatment for anorexia nervosa typica or atypica (ICD-10: F50.0 or F50.1)

Family-based treatment

Intervention Type BEHAVIORAL

Open-end family therapy ad modum The Maudsley model

Bulimia nervosa

Children and adolescents presenting for treatment for bulimia nervosa typica or atypica (ICD-10: F50.2 or F50.3)

Family-based treatment

Intervention Type BEHAVIORAL

Open-end family therapy ad modum The Maudsley model

Other eating disorders

Children and adolescents presenting for treatment for other eating disorders (ICD-10: F50.8)

Family-based treatment

Intervention Type BEHAVIORAL

Open-end family therapy ad modum The Maudsley model

Interventions

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Family-based treatment

Open-end family therapy ad modum The Maudsley model

Intervention Type BEHAVIORAL

Other Intervention Names

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FBT

Eligibility Criteria

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Inclusion Criteria

* begin treatment for eating disorder

Exclusion Criteria

* lack of informed consent
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mette Bentz, PhD

Role: PRINCIPAL_INVESTIGATOR

Child and Adolescent Mental Health Care Centre, Capital Region of Denmark

Anne Katrine Pagsberg, professor

Role: STUDY_DIRECTOR

Child and Adolescent Mental Health Care Centre, Capital Region of Denmark

Locations

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Child and Adolescent Mental Health Care Center

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Mette Bentz, PhD

Role: CONTACT

+45 38 64 10 35

Facility Contacts

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Mette Bentz, PhD

Role: primary

+45 38 64 10 35

References

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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 Jun 11. doi: 10.1007/s00787-025-02766-x. Online ahead of print.

Reference Type DERIVED
PMID: 40498327 (View on PubMed)

Other Identifiers

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H-17022391

Identifier Type: -

Identifier Source: org_study_id

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