Facilitators and Barriers in Anorexia Nervosa - Treatment Initiation (FABIANA)

Identification of Beneficial and Inhibitory Factors for Treatment in Patients With Anorexia Nervosa: A Pathway to Effective Secondary Prevention and Prognostic Improvement

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.

Study Overview

• Status: Unknown
• Conditions: Anorexia Nervosa; Feeding and Eating Disorders of Childhood
• Intervention / Treatment: Other: No intervention

Detailed Description

Anorexia nervosa (AN) is a comparably low-prevalent, yet due to its somatic and mental consequences serious 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). That is, 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. Based on this evidence, this study aims to derive recommendations for effective secondary prevention.

To our very best knowledge this is the first study investigating factors influencing the DUI using a multi-informant strategy, that is exploring the perspective of patients with AN, their significant carers and involved physicians. Furthermore, the study will avoid the confounding of patients with different eating disorder diagnoses, i.e. it will include exclusively patients with AN. Finally, there will be a clear focus on factors which are modifiable and precise in their definition.

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.

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

• Study Contact: Name: Angelika Weigel, Dr.; Phone Number: +4915222827125; Email: a.weigel@uke.de
• Study Contact Backup: Name: Laurence Reuter, Dr.; Phone Number: +4915222815684; Email: l.reuter@uke.de

Study Locations

• Germany
  • Bad Arolsen, Germany, 34454
    • Recruiting
    • Schön Clinic Bad Arolsen
    • Contact: M Seidel, Dr. med.
  • Bad Bevensen, Germany, 29549
    • Recruiting
    • Clinic Lüneburger Heide
    • Contact: W Wünsch-Leiteritz, Dr. med.
  • Bad Bodenteich, Germany, 29389
    • Recruiting
    • MediClin Seepark Clinic
    • Contact: Schwennen, Dr
  • Cuxhaven, Germany, 27472
    • Recruiting
    • Timmermann & Partner, Medical care center for physical and mental health
    • Contact: S Rieper
  • Hamburg, Germany, 20246
    • Active, not recruiting
    • Department of Child and Adolescent Psychiatry of the University Medical Center Hamburg-Eppendorf (UKE)
  • Hamburg, Germany, 20246
    • Enrolling by invitation
    • Local psychotherapists
  • Hamburg, Germany, 20251
    • Recruiting
    • Behavior therapy Falkenried MVZ GmbH
    • Contact: Kiki Peter
  • Hamburg, Germany, 20251
    • Recruiting
    • VT Falkenried Training and Education
    • Contact: Roman Wessels
  • Hamburg, Germany, 20559
    • Recruiting
    • Department of Psychosomatic Medicine and Psychotherapy, Asklepios West Clinic Hamburg
    • Contact: Helge Fehrs, Dr.
  • Hamburg, Germany, 22081
    • Recruiting
    • Schön Clinic Eilbek
    • Contact: Rebecca Albrecht, Dr.
  • Hamburg, Germany, 22081
    • Recruiting
    • Schön Clinic Hamburg Eilbek
    • Contact: Rebecca Albrecht, Dr.
  • Hamburg, Germany, 22085
    • Enrolling by invitation
    • Institute for Behavior Therapy Education Hamburg (IVAH)
  • Hamburg, Germany, 22419
    • Recruiting
    • Asklepios Clinic Nord - Ochsenzoll
    • Contact: Silke Hagena, Dipl.-Psych.
  • Regensburg, Germany, 93053
    • Recruiting
    • University Clinic Regensburg
    • Contact: Rumoald Brunner, Prof. Dr.
  • Rosengarten, Germany, 21224
    • Recruiting
    • Evangelic hospital Ginsterhof HmbH
    • Contact: Ute-Christine Haberer, Dr. med.
  • Bavaria
    • Prien am Chiemsee, Bavaria, Germany, 83209
      • Recruiting
      • Schön Clinic Roseneck
      • Contact: Ulrich Voderholzer, Prof. Dr.
  • Schleswig-Holstein
    • Bad Bramstedt, Schleswig-Holstein, Germany, 24576
      • Recruiting
      • Schön Clinic Bad Bramstedt
      • Contact: Bernhard Osen, Dr.
    • Bad Malente, Schleswig-Holstein, Germany, 23714
      • Recruiting
      • Curtius-Clinic, Specialist Clinic for Psychosomatics and Psychotherapeutic Medicine
      • Contact: Silke Kleinschmidt, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-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.

Description

AN patients

Inclusion criteria

• 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

Exclusion criteria

• Insufficient language skills
• Serious organic or psychiatric illnesses
• Acute suicidality

Significant caregiver

Inclusion criteria

• 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

Exclusion criteria - Insufficient language skills

Physician

Inclusion criteria

• 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

Exclusion criteria

- Insufficient language skills

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Survey during normal supply.
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; Survey during normal supply.
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; Survey during normal supply.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of first contact (DUC in month)	DUC is assessed cross-sectional (retrospectively) using standardized interviews and paper-and-pencil questionnaires.	from date of study enrolment up to 12 weeks

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: German Research Foundation
• Investigators: Principal Investigator: Antje Gumz, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf; Principal Investigator: Bernd Loewe, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2018
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): April 1, 2022

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (ACTUAL): October 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: treatment; adolescent; women; youth; factors; barriers; Anorexia nervosa [MeSH]; Feeding and Eating Disorders [MeSH]; duration of untreated illness (DUI); time-to-treatment [MeSH]; facilitators; first treatment initiation
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Anorexia; Anorexia Nervosa; Feeding and Eating Disorders; Feeding and Eating Disorders of Childhood
• Other Study ID Numbers: LO 766/16-1m; GU 156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No