Akershus University Hospital Retrospective Cohort Study of Family Based Treatment (ARCS-FBT)

Changes in Outcomes of Treatment for Adolescent Anorexia Nervosa After Implementation of Family Based Treatment in a Norwegian Child and Adolescent Mental Health Service: A Retrospective Cohort Study With Prospective Follow-up

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Anorexia Nervosa; Atypical Anorexia Nervosa
• Intervention / Treatment: Behavioral: Non-manualised family therapy.; Behavioral: Family Based Treatment

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 Type: Observational
• Enrollment (Estimated): 175

Contacts and Locations

Study Locations

• Norway
  • Lillestrøm, Norway
    • Nedre Romerike BUP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; Family therapy provided by qualified therapists without reference to a specific therapy manual.
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; Family therapy implemented according to the published "Treatment manual for anorexia nervosa: A family-based approach" by Lock & Le Grange (2nd edition, 2015).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant experiences and satisfaction with services	Generic Short Patient Experiences Questionnaire (GS-PEQ)	Assessed retrospectively at enrolment.

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Collaborators: Rådgivning om Spiseforstyrrelser
• Investigators: Principal Investigator: Erling W Rognli, PhD, University Hospital, Akershus

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2042

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: 2021_182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data cannot be shared for legal reasons.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No