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

Sponsor
University Hospital, Akershus (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05748457
Collaborator
Rådgivning om Spiseforstyrrelser (Other)
175
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236
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
175 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Dec 1, 2042

Arms and Interventions

Arm 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).

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. Mortality [Assessed 5, 10, 15 and 20 years post treatment.]

    Death from any cause.

  4. Level of education [Assessed 5, 10, 15 and 20 years post treatment.]

    Highest level of education achieved, obtained from national registries.

  5. 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.

  6. 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.

Other Outcome Measures

  1. Participant experiences and satisfaction with services [Assessed retrospectively at enrolment.]

    Generic Short Patient Experiences Questionnaire (GS-PEQ)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nedre Romerike BUP Lillestrøm Norway

Sponsors and Collaborators

  • University Hospital, Akershus
  • Rådgivning om Spiseforstyrrelser

Investigators

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

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Erling W. Rognli, Psykologspesialist, University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT05748457
Other Study ID Numbers:
  • 2021_182
First Posted:
Feb 28, 2023
Last Update Posted:
Feb 28, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 28, 2023