- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05734573
The Effectiveness of Eating Disorder Treatment
February 8, 2023 updated by: Svetlana Oshukova, Helsinki University Central Hospital
Effects of Family-based Treatment on Adolescent Outpatients Treated for Anorexia Nervosa in the Eating Disorder Unit of Helsinki University Hospital
Family-based treatment (FBT), a form of family therapy for eating disorders (ED) in young patients, has proven to be effective in numerous large-scale studies.
This study aims to evaluate outcomes of the treatment for anorexia nervosa (AN) in a 'real-world' setting in a specialized outpatient clinic in Helsinki, Finland.
Fifty-two young female patients seen for treatment between June 2013 and December 2017 were included in the study.
Demographic and treatment characteristics, weight, and ED symptoms before and after treatment are reported
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Aim: The naturalistic outcome of outpatient FBT for adolescent AN was investigated.
Methods: Fifty-two female patients and their families who received FBT at a tertiary eating disorders unit participated in the study. Data on their pre-treatment parameters, treatment details, and condition at the end of treatment (EOT) was collected from their medical records
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
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
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Clinical diagnosis of Anorexia nervosa
- Admitted to FBT at the Eating Disorder Unit from June 1, 2013, through December 31, 2017
Exclusion Criteria:
- No exclusions
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
% of patients with body weight normalization in treatment
Time Frame: Treatment period, aprox. 1 year
|
Rate of patients with a normal body weight defined as a BMI over 18.5 at the end of treatment was calculated.
|
Treatment period, aprox. 1 year
|
% of patients with eating disorder symptoms at the end of treatment
Time Frame: Treatment period, aprox. 1 year
|
The data of any eating disorder symptoms detected by a psychiatrist at the end of treatment were collected from the medical records, and the incidence was calculated.
|
Treatment period, aprox. 1 year
|
% of patients in need for a further treatment after the intervention
Time Frame: Treatment period, aprox. 1 year
|
Rate of patients who still needed treatment after the FBT intervention from was assessed at the end of treatment.
The data were obtained from the medical files of the patients.
|
Treatment period, aprox. 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jaana Suokas, Dos, Helsinki University Central Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jones M, Volker U, Lock J, Taylor CB, Jacobi C. Family-based early intervention for anorexia nervosa. Eur Eat Disord Rev. 2012 May;20(3):e137-43. doi: 10.1002/erv.2167. Epub 2012 Mar 22.
- Lock J. Family therapy for eating disorders in youth: current confusions, advances, and new directions. Curr Opin Psychiatry. 2018 Nov;31(6):431-435. doi: 10.1097/YCO.0000000000000451.
- Lock J, Le Grange D. Family-based treatment: Where are we and where should we be going to improve recovery in child and adolescent eating disorders. Int J Eat Disord. 2019 Apr;52(4):481-487. doi: 10.1002/eat.22980. Epub 2018 Dec 6.
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)
June 1, 2013
Primary Completion (Actual)
December 31, 2017
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
January 8, 2023
First Submitted That Met QC Criteria
February 8, 2023
First Posted (Estimate)
February 20, 2023
Study Record Updates
Last Update Posted (Estimate)
February 20, 2023
Last Update Submitted That Met QC Criteria
February 8, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 653/13/01/03/2015/1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The dataset generated for the study is not publicly available due to privacy restrictions.
The data are available on request from the principal investigator
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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