Akershus University Hospital Retrospective Cohort Study of Family Based Treatment

• Conditions: Atypical Anorexia Nervosa; Anorexia Nervosa

• Registration Number: NCT05748457
• Lead Sponsor: University Hospital, Akershus

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.

Detailed Description

A two-group retrospective exploratory cohort study with longitudinal follow-up comparing adolescents with anorexia nervosa treated with generic family therapy to those treated with the manualised Family Based Treatment (FBT). The primary aim is to investigate whether adoption of FBT has led to faster normalisation of weight and lower rates of eating disorder in early adulthood. Secondary aims are to investigate whether implementation of FBT has changed the time to discharge, heterogeneity of patient weight change across treatment, rates of adverse events, rates of readmission, patient experiences of the treatment, long term functional outcomes and mortality. Data are extracted from patient health records, reported by participants and extracted from public registries.

Study Timeline

• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-02-28
• Study Start: 2023-03-27
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14
• Primary Completion: 2024-06
• Study Completion: 2042-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to weight restoration	Assessed retrospectively at enrolment.	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.

Secondary Outcome Measures

Name	Time	Method
Time to discharge from treatment	Assessed retrospectively at enrolment.	Number of days from start of treatment to the date of discharge from the outpatient clinic.
Mortality	Assessed 5, 10, 15 and 20 years post treatment.	Death from any cause.
Employment status and welfare benefits	Assessed 5, 10, 15 and 20 years post treatment.	Employment status or receipt of welfare benefits, obtained from national registries.
Time to readmission to treatment	Assessed retrospectively at enrolment.	Number of days from start of treatment to any date of readmission to the outpatient clinic.
Level of education	Assessed 5, 10, 15 and 20 years post treatment.	Highest level of education achieved, obtained from national registries.
Treatment for eating disorder in adulthood	Assessed 5, 10, 15 and 20 years post treatment.	Treatment in specialist mental health services for any eating disorder.

Trial Locations

Locations (1)

Nedre Romerike BUP; 🇳🇴 Lillestrøm, Norway