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

August 29, 2024 updated by: Erling W. Rognli, University Hospital, Akershus

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

Terminated

Conditions

Intervention / 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 (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Lillestrøm, Norway
        • Nedre Romerike BUP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 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.
Assessed retrospectively at enrolment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to discharge from treatment
Time Frame: Assessed retrospectively at enrolment.
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
Time Frame: Assessed retrospectively at enrolment.
Number of days from start of treatment to any date of readmission to the outpatient clinic.
Assessed retrospectively at enrolment.
Mortality
Time Frame: Assessed 5, 10, 15 and 20 years post treatment.
Death from any cause.
Assessed 5, 10, 15 and 20 years post treatment.
Level of education
Time Frame: Assessed 5, 10, 15 and 20 years post treatment.
Highest level of education achieved, obtained from national registries.
Assessed 5, 10, 15 and 20 years post treatment.
Employment status and welfare benefits
Time Frame: Assessed 5, 10, 15 and 20 years post treatment.
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
Time Frame: Assessed 5, 10, 15 and 20 years post treatment.
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
Time Frame: Assessed retrospectively at enrolment.
Generic Short Patient Experiences Questionnaire (GS-PEQ)
Assessed retrospectively at enrolment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Akershus

Collaborators

Rådgivning om Spiseforstyrrelser

Investigators

  • Principal Investigator: Erling W Rognli, PhD, University Hospital, Akershus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2023

Primary Completion (Actual)

August 29, 2024

Study Completion (Actual)

August 29, 2024

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)

September 3, 2024

Last Update Submitted That Met QC Criteria

August 29, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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