NCT03713541

Brief Summary

Anorexia nervosa (AN) is a comparably low-prevalent illness. Chronic courses are often and the mortality rate of patients with AN is higher than in any other mental illness. A major influence on the course of the illness is the interval between the onset of AN symptoms and the beginning of an adequate treatment (duration of untreated illness, DUI). Patients with AN have a better prognosis if treated early. Previous large-scale interventions have not shown the desired positive effects on the DUI. Therefore, an important starting point seems to be a better initial understanding of the factors influencing the DUI, which is the major aim of this project. The planned mixed-method study is divided in three consecutive sub-studies. The first substudy aims to identify modifiable factors influencing the DUI using semi-structured interviews and a multi-informant approach (patients, carers, physicians). As a result of this qualitative analyses using Grounded Theory the most relevant factors will be determined. The motivation of the second substudy is to condense the factors identified to influence the DUI into a checklist and to conduct a first psychometric evaluation of this newly developed instrument. The third substudy aims to quantitatively determine the magnitude of the effects of a) a priori determined non-modifiable factors and b) the modifiable checklist-factors using a multi-informant approach (planned n for each informant = 130; 13 co-operating specialized clinics and 6 cooperating outpatient partners). Additional outpatient partners may be recruited during the course of the study. In conclusion, the study aims to derive recommendations for effective secondary prevention. Thereby, the study might ultimately contribute to earlier treatment initiation of patients with AN, and to the prevention of chronic courses and the associated high health care costs and individual burden.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

18 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

3.3 years

First QC Date

August 23, 2018

Last Update Submit

November 10, 2020

Conditions

Anorexia NervosaFeeding and Eating Disorders of Childhood

Keywords

Anorexia nervosa [MeSH]Feeding and Eating Disorders [MeSH]womenyouthadolescentduration of untreated illness (DUI)time-to-treatment [MeSH]facilitatorsbarriersfactorstreatmentfirst treatment initiation

Outcome Measures

Primary Outcomes (1)

  • Duration of untreated illness (DUI in months)

    DUI (defined as the time between occurence of first symptoms and treatment) is assessed retrospectively and cross-sectional using standardized interviews and paper-and-pencil questionnaires.

    from date of study enrolment up to 12 weeks

Secondary Outcomes (1)

  • Duration of first contact (DUC in month)

    from date of study enrolment up to 12 weeks

Study Arms (3)

Patients with Anorexia nervosa (AN)

Female patients with Anorexia nervosa (AN, ICD-10: F50.0/1) of 14 years and older, receiving an initial treatment due to their AN (start of initial treatment no longer than 3 months ago, inpatient care: at least 7 days inpatient; outpatient care: at least 5 sessions with the same therapist) with sufficient language skills and no serious organic or psychiatric illnesses and no acute suicidality will be consecutively included in the study. No intervention.

Other: No intervention

Carers of patients with AN

Significant caregivers in AN patients aged 14 to 15 years: parents; in AN patients aged 16 years and over: parents or other significant carer. No intervention.

Other: No intervention

Physicians of patients with AN

Resident general practitioner, pediatrician, internist or gynecologist with at least one medical patient contact within the last 12 months. No intervention.

Other: No intervention

Interventions

No interventionOTHER

Survey during normal supply.

Carers of patients with ANPatients with Anorexia nervosa (AN)Physicians of patients with AN

Eligibility Criteria

Age14 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with AN will be recruited from n=13 inpatient clinics with special treatment units/specialized inpatient units and n=6 outpatient psychotherapists specialized for eating disorders. Additional outpatient partner may be recruited during the course of the study.

You may qualify if:

  • Female patients, 14 years and older
  • Treatment diagnosis anorexia nervosa (ICD-10: F50.0/1)
  • Initial treatment (start of initial treatment no longer than 3 months ago)
  • Inpatient care: at least 7 days inpatient
  • Outpatient care: at least 5 sessions with the same therapist

You may not qualify if:

  • Insufficient language skills
  • Serious organic or psychiatric illnesses
  • Acute suicidality
  • Significant caregiver
  • in AN patients aged 14 to 15 years: parents ; in AN patients aged 16 years and over: parents or other significant carer
  • Informed consent
  • Consent of the patient
  • Physician
  • Resident general practitioner, pediatrician, internist or gynecologist
  • At least one medical patient contact within the last 12 months
  • Informed consent
  • Consent of the patient and release from confidentiality
  • \- Insufficient language skills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Schön Clinic Roseneck

Prien am Chiemsee, Bavaria, 83209, Germany

RECRUITING

Schön Clinic Bad Bramstedt

Bad Bramstedt, Schleswig-Holstein, 24576, Germany

RECRUITING

Curtius-Clinic, Specialist Clinic for Psychosomatics and Psychotherapeutic Medicine

Malente, Schleswig-Holstein, 23714, Germany

RECRUITING

Schön Clinic Bad Arolsen

Bad Arolsen, 34454, Germany

RECRUITING

Clinic Lüneburger Heide

Bad Bevensen, 29549, Germany

RECRUITING

MediClin Seepark Clinic

Bodenteich, 29389, Germany

RECRUITING

Timmermann & Partner, Medical care center for physical and mental health

Cuxhaven, 27472, Germany

RECRUITING

Department of Child and Adolescent Psychiatry of the University Medical Center Hamburg-Eppendorf (UKE)

Hamburg, 20246, Germany

ACTIVE NOT RECRUITING

Local psychotherapists

Hamburg, 20246, Germany

ENROLLING BY INVITATION

Behavior therapy Falkenried MVZ GmbH

Hamburg, 20251, Germany

RECRUITING

VT Falkenried Training and Education

Hamburg, 20251, Germany

RECRUITING

Department of Psychosomatic Medicine and Psychotherapy, Asklepios West Clinic Hamburg

Hamburg, 20559, Germany

RECRUITING

Schön Clinic Eilbek

Hamburg, 22081, Germany

RECRUITING

Schön Clinic Hamburg Eilbek

Hamburg, 22081, Germany

RECRUITING

Institute for Behavior Therapy Education Hamburg (IVAH)

Hamburg, 22085, Germany

ENROLLING BY INVITATION

Asklepios Clinic Nord - Ochsenzoll

Hamburg, 22419, Germany

RECRUITING

University Clinic Regensburg

Regensburg, 93053, Germany

RECRUITING

Evangelic hospital Ginsterhof HmbH

Rosengarten, 21224, Germany

RECRUITING

Related Publications (3)

  • Reuter L, Kastner D, Schmidt J, Weigel A, Voderholzer U, Seidel M, Schwennen B, Fehrs H, Lowe B, Gumz A. The development and psychometric evaluation of FABIANA-checklist: a scale to assess factors influencing treatment initiation in anorexia nervosa. J Eat Disord. 2021 Nov 3;9(1):144. doi: 10.1186/s40337-021-00490-w.

    PMID: 34732246DERIVED

  • Kastner D, Weigel A, Buchholz I, Voderholzer U, Lowe B, Gumz A. Facilitators and barriers in anorexia nervosa treatment initiation: a qualitative study on the perspectives of patients, carers and professionals. J Eat Disord. 2021 Feb 27;9(1):28. doi: 10.1186/s40337-021-00381-0.

    PMID: 33640028DERIVED

  • Kastner D, Buchholz I, Weigel A, Brunner R, Voderholzer U, Gumz A, Lowe B. Facilitators and barriers in anorexia nervosa treatment initiation (FABIANA): study protocol for a mixed-methods and multicentre study. BJPsych Open. 2019 Oct 21;5(6):e92. doi: 10.1192/bjo.2019.77.

    PMID: 31631825DERIVED

MeSH Terms

Conditions

Anorexia NervosaFeeding and Eating Disorders of Childhood

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Antje Gumz, Prof. Dr.

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

  • Bernd Loewe, Prof. Dr.

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelika Weigel, Dr.

CONTACT

+4915222827125a.weigel@uke.de

Laurence Reuter, Dr.

CONTACT

+4915222815684l.reuter@uke.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2018

First Posted

October 19, 2018

Study Start

May 1, 2018

Primary Completion

August 1, 2021

Study Completion

April 1, 2022

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations

DE(18)