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The Effectiveness of Eating Disorder Treatment

Primary Purpose

Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Family-based treatment
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders

Eligibility Criteria

13 Years - 18 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    % of patients with body weight normalization in treatment
    Rate of patients with a normal body weight defined as a BMI over 18.5 at the end of treatment was calculated.
    % of patients with eating disorder symptoms at the end of treatment
    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.
    % of patients in need for a further treatment after the intervention
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 8, 2023
    Last Updated
    February 8, 2023
    Sponsor
    Helsinki University Central Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05734573
    Brief Title
    The Effectiveness of Eating Disorder Treatment
    Official Title
    Effects of Family-based Treatment on Adolescent Outpatients Treated for Anorexia Nervosa in the Eating Disorder Unit of Helsinki University Hospital
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2013 (Actual)
    Primary Completion Date
    December 31, 2017 (Actual)
    Study Completion Date
    December 31, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Helsinki University Central Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eating Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Family-based treatment
    Intervention Description
    FBT is carried out by a family therapist who has received FBT training. The duration of FBT is commonly 6-12 months, in most cases comprising 10-20 sessions. At the beginning of treatment, there are weekly sessions; later in treatment, the sessions are less frequent. The patient and their family meet their psychiatrist every four to six weeks, and the family therapist also takes part in these meetings. The treatment is implemented in accordance with the FBT treatment manual.
    Primary Outcome Measure Information:
    Title
    % of patients with body weight normalization in treatment
    Description
    Rate of patients with a normal body weight defined as a BMI over 18.5 at the end of treatment was calculated.
    Time Frame
    Treatment period, aprox. 1 year
    Title
    % of patients with eating disorder symptoms at the end of treatment
    Description
    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.
    Time Frame
    Treatment period, aprox. 1 year
    Title
    % of patients in need for a further treatment after the intervention
    Description
    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.
    Time Frame
    Treatment period, aprox. 1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jaana Suokas, Dos
    Organizational Affiliation
    Helsinki University Central Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing 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
    Citations:
    PubMed Identifier
    22438094
    Citation
    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.
    Results Reference
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    PubMed Identifier
    30063479
    Citation
    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.
    Results Reference
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    PubMed Identifier
    30520532
    Citation
    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.
    Results Reference
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    The Effectiveness of Eating Disorder Treatment

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