NCT03968705

Brief Summary

Background Eating disorders rank among the ten leading causes of disability among young women, and anorexia nervosa has the highest mortality rate of all mental disorders. Follow-up studies have shown that 20-30 % of patients with eating disorders develop longstanding symptoms, seriously impairing their daily and represents a public health concern. There are very few studies on the course of these patients. Several studies have demonstrated comorbidity between eating disorders and personality disorders. Among patients with eating disorders, the reported frequencies of personality disorders vary from 27% to 77%. Most of the studies are cross-sectional designs, thus unable to catch trends or changes over time. There is a need for prospective longitudinal studies of adult patients using structured diagnostic interviews both for eating disorders and personality disorders. At Modum Bad, a Norwegian psychiatric hospital, the investigators have conducted a follow-up study of patients with longstanding eating disorder 1-, 2- and 5-years after treatment. The aim of the present project is to follow-up the patients additional 17-years after treatment. Objective Investigate the 17-years course and outcome of adult patients with severe and longstanding eating disorders with regard to eating disorder-related symptoms, general symptoms and personality disorders in addition to examining whether personality disorders and sexual abuse in childhood can predict the course and outcome. Method Examining patients 17-years after treatment with standardized interviews and questionnaires.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 1998

Longer than P75 for all trials

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
21.3 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

23.3 years

First QC Date

April 30, 2019

Last Update Submit

May 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in number of patients no longer fulfilling criteria for an eating disorder diagnosis

    Frequency of patients no longer fulfilling criteria for an eating disorder diagnosis based on structured interviews

    Admission, after 6-months of treatment, 1-year after treatment, 2-year after treatment, 5-year after treatment and 17-year after treatment

Secondary Outcomes (2)

  • Frequencies of bingeing and compensating behaviour

    Admission, after 6-months of treatment, 1-year after treatment, 2-year after treatment, 5-year after treatment and 17-year after treatment

  • Number of patients in recovery status based on BMI, Eating Disorder Examination global score and Frequencies of bingeing and compensating behaviour

    Admission, after 6-months of treatment, 1-year after treatment, 2-year after treatment, 5-year after treatment and 17-year after treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with longstanding eating disorder

You may qualify if:

  • Symptoms of anorexia nervosa, bulimia nervosa, and eating disorder not otherwise specified that impaired daily functioning
  • Inadequate responses to previous treatment
  • Age above 18

You may not qualify if:

  • Serious medical complication
  • Body mass index (BMI) below 14

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Eielsen HP, Vrabel K, Hoffart A, Ro O, Rosenvinge JH. Reciprocal relationships between personality disorders and eating disorders in a prospective 17-year follow-up study. Int J Eat Disord. 2022 Dec;55(12):1753-1764. doi: 10.1002/eat.23823. Epub 2022 Oct 10.

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 30, 2019

Study Start

January 1, 1998

Primary Completion

March 31, 2021

Study Completion

December 30, 2025

Last Updated

May 8, 2025

Record last verified: 2025-05