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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05748457
Other study ID # 2021_182
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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.
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