Clinical trial NCT03713541: Facilitators and Barriers in Anorexia Nervosa - Treatment Initiation
Official title: Identification of Beneficial and Inhibitory Factors for Treatment in Patients With Anorexia Nervosa: A Pathway to Effective Secondary Prevention and Prognostic Improvement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anorexia Nervosa
Feeding and Eating Disorders of Childhood
Keywords: Anorexia nervosa [MeSH]
Feeding and Eating Disorders [MeSH]
women
youth
adolescent
duration of untreated illness (DUI)
time-to-treatment [MeSH]
facilitators
barriers
factors
treatment
first treatment initiation
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2018-10-19
Enrollment: 450
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of untreated illness (DUI in months)
timeFrame: from date of study enrolment up to 12 weeks
Secondary outcomes:
measure: Duration of first contact (DUC in month)
timeFrame: from date of study enrolment up to 12 weeks
Other outcomes:
Locations:
city: Prien am Chiemsee
country: Germany
facility: Schön Clinic Roseneck
state: Bavaria
city: Bad Bramstedt
country: Germany
facility: Schön Clinic Bad Bramstedt
state: Schleswig-Holstein
city: Bad Malente
country: Germany
facility: Curtius-Clinic, Specialist Clinic for Psychosomatics and Psychotherapeutic Medicine
state: Schleswig-Holstein
city: Bad Arolsen
country: Germany
facility: Schön Clinic Bad Arolsen
city: Bad Bevensen
country: Germany
facility: Clinic Lüneburger Heide
city: Bad Bodenteich
country: Germany
facility: MediClin Seepark Clinic
city: Cuxhaven
country: Germany
facility: Timmermann & Partner, Medical care center for physical and mental health
city: Hamburg
country: Germany
facility: Department of Child and Adolescent Psychiatry of the University Medical Center Hamburg-Eppendorf (UKE)
city: Hamburg
country: Germany
facility: Local psychotherapists
city: Hamburg
country: Germany
facility: Behavior therapy Falkenried MVZ GmbH
city: Hamburg
country: Germany
facility: VT Falkenried Training and Education
city: Hamburg
country: Germany
facility: Department of Psychosomatic Medicine and Psychotherapy, Asklepios West Clinic Hamburg
city: Hamburg
country: Germany
facility: Schön Clinic Eilbek
city: Hamburg
country: Germany
facility: Schön Clinic Hamburg Eilbek
city: Hamburg
country: Germany
facility: Institute for Behavior Therapy Education Hamburg (IVAH)
city: Hamburg
country: Germany
facility: Asklepios Clinic Nord - Ochsenzoll
city: Regensburg
country: Germany
facility: University Clinic Regensburg
city: Rosengarten
country: Germany
facility: Evangelic hospital Ginsterhof HmbH
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Antje Gumz, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Bernd Loewe, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.