Akershus University Hospital Retrospective Cohort Study of Family Based Treatment

Anorexia Nervosa Clinical Trial

— ARCS-FBT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05748457
• Other study ID #: 2021_182
• Status: Enrolling by invitation
• Start date: March 27, 2023
• Est. completion date: December 2042

Study information

• Verified date: August 2023
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 175
• Est. completion date: December 2042
• Est. primary completion date: June 2024
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Atypical Anorexia Nervosa

Intervention

Behavioral:
• Non-manualised family therapy.
Family therapy provided by qualified therapists without reference to a specific therapy manual.
• 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).

Locations

Country	Name	City	State
Norway	Nedre Romerike BUP	Lillestrøm

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Akershus	Rådgivning om Spiseforstyrrelser

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant experiences and satisfaction with services	Generic Short Patient Experiences Questionnaire (GS-PEQ)	Assessed retrospectively at enrolment.
Primary	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	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.
Secondary	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.
Secondary	Mortality	Death from any cause.	Assessed 5, 10, 15 and 20 years post treatment.
Secondary	Level of education	Highest level of education achieved, obtained from national registries.	Assessed 5, 10, 15 and 20 years post treatment.
Secondary	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.
Secondary	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.