NCT05748457

Brief Summary

The goal of this observational study is to compare short and long-term effects of manualised Family Based Treatment for adolescent anorexia nervosa to those of non-manualised family therapy. The study will approach former patients who were treated before and after Family Based Therapy was adopted in an outpatient clinic, and extract data from electronic health records and public registries.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

March 27, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2024

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

1.4 years

First QC Date

February 16, 2023

Last Update Submit

August 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to weight restoration

    Number of days from start of treatment to a weight measurement placing the patient at or above 95% of expected body weight (50. percentile) for age and sex given Norwegian population norms.

    Assessed retrospectively at enrolment.

Secondary Outcomes (6)

  • Time to discharge from treatment

    Assessed retrospectively at enrolment.

  • Time to readmission to treatment

    Assessed retrospectively at enrolment.

  • Mortality

    Assessed 5, 10, 15 and 20 years post treatment.

  • Level of education

    Assessed 5, 10, 15 and 20 years post treatment.

  • Employment status and welfare benefits

    Assessed 5, 10, 15 and 20 years post treatment.

  • +1 more secondary outcomes

Other Outcomes (1)

  • Participant experiences and satisfaction with services

    Assessed retrospectively at enrolment.

Study Arms (2)

2015-2017

Patients treated for anorexia nervosa in the years 2015-2017 at Nedre Romerike outpatient clinic, Department of child and adolescent mental health services, Akershus university hospital.

Behavioral: Non-manualised family therapy.

2018-2020

Patients treated for anorexia nervosa in the years 2018-2020 at Nedre Romerike outpatient clinic, Department of child and adolescent mental health services, Akershus university hospital.

Behavioral: Family Based Treatment

Interventions

Family therapy provided by qualified therapists without reference to a specific therapy manual.

2015-2017

Family therapy implemented according to the published "Treatment manual for anorexia nervosa: A family-based approach" by Lock \& Le Grange (2nd edition, 2015).

2018-2020

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients initiating treatment during the years 2015-2020 with the eating disorder team at Nedre Romerike outpatient clinic at Akershus university hospital, Department of child and adolescent mental health services.

You may qualify if:

  • Clinical diagnosis of F50.0 Anorexia nervosa or F50.1 Atypical anorexia nervosa according to the International Classification of Diseases-10.

You may not qualify if:

  • Patient was treated during the years 2018-2020 and FBT was never initiated according to patient health records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nedre Romerike BUP

Lillestrøm, Norway

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Erling W Rognli, PhD

    University Hospital, Akershus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psykologspesialist

Study Record Dates

First Submitted

February 16, 2023

First Posted

February 28, 2023

Study Start

March 27, 2023

Primary Completion

August 29, 2024

Study Completion

August 29, 2024

Last Updated

September 3, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Individual participant data cannot be shared for legal reasons.

Locations