Feeding and Eating DisordersNCT03968705
Longstanding Eating Disorders and Personality Disorders
An observational study of Feeding and Eating Disorders, run by Modum Bad.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Feeding and Eating Disorders
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Jan 1998to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients with longstanding eating disorder
Who may be able to join
- Symptoms of anorexia nervosa, bulimia nervosa, and eating disorder not otherwise specified that impaired daily functioning
- Inadequate responses to previous treatment
- Age above 18
Who cannot join
- Serious medical complication
- Body mass index (BMI) below 14
About this study
Official title: Longstanding Eating Disorders and Personality Disorders, Mediators for 17-years Long Term Outcome
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.
Read more
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.
Read the detailed description
Participants From August 1998 to June 2001, 92 consecutive patients were admitted to a specialized eating disorder unit at a psychiatric hospital, Modum Bad. The admission criteria were symptoms of anorexia nervosa, bulimia nervosa, and eating disorder not otherwise specified that impaired daily life functioning, inadequate responses to previous treatment and age above 18 years. Those with severe medical complications and body mass index (BMI) < 14 were excluded. Patients were allocated to specific inpatient treatment programs for anorexia nervosa and bulimia nervosa respectively. Six patients discharged themselves during the first two weeks. A total of 86 remaining patients, one male and 85 female, initially entered the study. Participants have been assessed at five points in time, i.e. 1 (Admission, 1998-2001), 2 (Discharge, 1998-2001), 3 (one year after admission, 2001-2002), 4 (two years after admission, 2002-2003) and time 5 (five years after admission, 2004-2005). A total of 77 patients (90 %) were available for the five-year follow-up. These patients have given written consent to participate in a 17-year follow-up. Attrition is a common problem in long-term follow-up investigations, but appears to be less severe in Norway generally and at Modum Bad in particular.
Aims Study 1: Investigate the course and outcome of eating disorder patients Subordinate aims included: to a) report on the 17-year course and outcome of adults with longstanding eating disorder and b) identify eating disorder subgroups with various courses and outcomes.
Study 2: Investigate the course of personlaity disorders among eating disorder patients Subordinate aims included: to a) report the presence of categorical and dimensional personality disorder in adults with longstanding eating disorder at admission to hospital treatment and at 1-, 2- 5-year and 17-year follow-up; b) compare the changes of personality disorder in anorexia nervosa, bulimia nervosa, and eating disorder not otherwise specified; c) investigate if personality disorder is less frequent among recovered patients; d) compare the magnitude of changes in specific eating disorder symptoms, general psychopathology and personality disorder; e) investigate whether changes in personality disorder influence changes in symptom scores, or vice versa.
Study 3: Identify predictors of poor outcome in longstanding eating disorder Subordinated aims included: to a) investigate if personality disorder and child sexual abuse predict the course of severity of eating disorder symptoms, b) examine how child sexual abuse and personality disorder interact to affect the eating disorder course. Does persoanlity disorder mediate, does child sexual abuse moderate, or do they independently influence the eating disorder course?
Feasibility: design, method, analysis The present sample is unique in having participating in a previous prospective longitudinal study of adult patients using structured diagnostic interviews both for the eating disorder and the personality disorder. The very longterm course and outcome can be evaluated. There are no other studies where several repeated structured clinical interviews have been used to assess personality disorders in a sample of patients with eating disorders. This study may bridge the gap between science and practice in the assessment and treatment of severe eating disorder patients. As there are no generally accepted guidelines for treatment of severe eating disorder, the present finding may elicit efforts to develop such guidelines. The main finding in the previous studies is that a majority of patients with severe and longstanding eating disorder experience significant improvement that is fairly stable through years. This knowledge stands in contrast to a widespread professional opinion that there is little chance of improvement for individuals with longstanding eating disorder. Bridging the gap between science and clinical practice the refuting of this opinion by dissemination of research findings stands out as an important implication as one aspect of being a clinician is to provide a realistic hope to patients and relatives. However the previous studies do not provide the full knowledge of the full course of eating disorder. Thus, a further extension of the study is important.
- Conditions
- Feeding and Eating Disorders
- Medical subject headings
- Feeding and Eating Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Change from baseline in eating disorder symptoms, hence frequencies of bingeing and compensating behaviour
Measured: 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
Distribution of patients in pre-defined categories based on behavioral symptoms, BMI and global eating disorder examination index
Measured: Admission, after 6-months of treatment, 1-year after treatment, 2-year after treatment, 5-year after treatment and 17-year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study startJan 1998
- Primary completion31 Mar 2021
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feeding and Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Modum Bad
- Sponsor type
- University, hospital or other
- Collaborators
- The Norwegian Women´s Public Health Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968705
- Sponsor's protocol ID
- ModumBad
- Status last verified
- May 2025
- First submitted
- 30 Apr 2019
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36214278
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longstanding Eating Disorders and Personality Disorders, Mediators for 17-years Long Term Outcome
- ClinicalTrials.gov ID
- NCT03968705
- Acronym / sponsor ID
- ModumBad
- Conditions
- Feeding and Eating Disorders
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Modum BadUniversity, hospital or other
- Collaborators
- The Norwegian Women´s Public Health Association
- Study start
- Jan 1998 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants From August 1998 to June 2001, 92 consecutive patients were admitted to a specialized eating disorder unit at a psychiatric hospital, Modum Bad. The admission criteria were symptoms of anorexia nervosa, bulimia nervosa, and eating disorder not otherwise specified that impaired daily life functioning, inadequate responses to previous treatment and age above 18 years. Those with severe medical complications and body mass index (BMI) < 14 were excluded. Patients were allocated to specific inpatient treatment programs for anorexia nervosa and bulimia nervosa respectively. Six patients discharged themselves during the first two weeks. A total of 86 remaining patients, one male and 85 female, initially entered the study. Participants have been assessed at five points in time, i.e. 1 (Admission, 1998-2001), 2 (Discharge, 1998-2001), 3 (one year after admission, 2001-2002), 4 (two years after admission, 2002-2003) and time 5 (five years after admission, 2004-2005). A total of 77 patients (90 %) were available for the five-year follow-up. These patients have given written consent to participate in a 17-year follow-up. Attrition is a common problem in long-term follow-up investigations, but appears to be less severe in Norway generally and at Modum Bad in particular.
Aims Study 1: Investigate the course and outcome of eating disorder patients Subordinate aims included: to a) report on the 17-year course and outcome of adults with longstanding eating disorder and b) identify eating disorder subgroups with various courses and outcomes.
Study 2: Investigate the course of personlaity disorders among eating disorder patients Subordinate aims included: to a) report the presence of categorical and dimensional personality disorder in adults with longstanding eating disorder at admission to hospital treatment and at 1-, 2- 5-year and 17-year follow-up; b) compare the changes of personality disorder in anorexia nervosa, bulimia nervosa, and eating disorder not otherwise specified; c) investigate if personality disorder is less frequent among recovered patients; d) compare the magnitude of changes in specific eating disorder symptoms, general psychopathology and personality disorder; e) investigate whether changes in personality disorder influence changes in symptom scores, or vice versa.
Study 3: Identify predictors of poor outcome in longstanding eating disorder Subordinated aims included: to a) investigate if personality disorder and child sexual abuse predict the course of severity of eating disorder symptoms, b) examine how child sexual abuse and personality disorder interact to affect the eating disorder course. Does persoanlity disorder mediate, does child sexual abuse moderate, or do they independently influence the eating disorder course?
Feasibility: design, method, analysis The present sample is unique in having participating in a previous prospective longitudinal study of adult patients using structured diagnostic interviews both for the eating disorder and the personality disorder. The very longterm course and outcome can be evaluated. There are no other studies where several repeated structured clinical interviews have been used to assess personality disorders in a sample of patients with eating disorders. This study may bridge the gap between science and practice in the assessment and treatment of severe eating disorder patients. As there are no generally accepted guidelines for treatment of severe eating disorder, the present finding may elicit efforts to develop such guidelines. The main finding in the previous studies is that a majority of patients with severe and longstanding eating disorder experience significant improvement that is fairly stable through years. This knowledge stands in contrast to a widespread professional opinion that there is little chance of improvement for individuals with longstanding eating disorder. Bridging the gap between science and clinical practice the refuting of this opinion by dissemination of research findings stands out as an important implication as one aspect of being a clinician is to provide a realistic hope to patients and relatives. However the previous studies do not provide the full knowledge of the full course of eating disorder. Thus, a further extension of the study is important.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients with longstanding eating disorder
Key inclusion criteria (3 listed)
- Symptoms of anorexia nervosa, bulimia nervosa, and eating disorder not otherwise specified that impaired daily functioning
- Inadequate responses to previous treatment
- Age above 18
Key exclusion criteria (2 listed)
- Serious medical complication
- Body mass index (BMI) below 14
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in number of patients no longer fulfilling criteria for an eating disorder diagnosis
Time frame: Admission, after 6-months of treatment, 1-year after treatment, 2-year after treatment, 5-year after treatment and 17-year after treatment
Frequency of patients no longer fulfilling criteria for an eating disorder diagnosis based on structured interviews
2 secondary outcomes
Frequencies of bingeing and compensating behaviour
Time frame: 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
Time frame: Admission, after 6-months of treatment, 1-year after treatment, 2-year after treatment, 5-year after treatment and 17-year after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Derived from this study: PubMed 36214278Eielsen 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.
Related trials for Feeding and Eating Disorders
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Recruiting
Metacognitive Bibliotherapy for Anxiety, Depression, and Metacognitions in University Students
Anxiety, Depression
Recruiting
Time Restricted Eating for WeIght LoSs MainTenance-2
Weight Loss, Weight Gain
Active, not recruiting
Project VIBE: Virtual Intervention for Binge Eating in Adolescents
Obesity, Binge-Eating Disorder
RecruitingObservational study
Exploratory Study of Sensory Profile and Coping Strategies in Eating Disorders
Eating Disorders, Anorexia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Feeding and Eating Disorders, run by Modum Bad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of patients no longer fulfilling criteria for an eating disorder diagnosis (time frame: Admission, after 6-months of treatment, 1-year after treatment, 2-year after treatment, 5-year after treatment and 17-year after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03968705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.