Facilitators and Barriers in Anorexia Nervosa - Treatment Initiation

• Conditions: Anorexia Nervosa; Feeding and Eating Disorders of Childhood

• Registration Number: NCT03713541
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-10-17
• Study First Posted: 2018-10-19
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-13
• Primary Completion: 2021-08
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of untreated illness (DUI in months)	from date of study enrolment up to 12 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (18)

Schön Clinic Roseneck; 🇩🇪 Prien am Chiemsee, Bavaria, Germany

Schön Clinic Bad Bramstedt; 🇩🇪 Bad Bramstedt, Schleswig-Holstein, Germany

Curtius-Clinic, Specialist Clinic for Psychosomatics and Psychotherapeutic Medicine; 🇩🇪 Bad Malente, Schleswig-Holstein, Germany

Schön Clinic Bad Arolsen; 🇩🇪 Bad Arolsen, Germany

Clinic Lüneburger Heide; 🇩🇪 Bad Bevensen, Germany

MediClin Seepark Clinic; 🇩🇪 Bad Bodenteich, Germany

Timmermann & Partner, Medical care center for physical and mental health; 🇩🇪 Cuxhaven, Germany

Department of Child and Adolescent Psychiatry of the University Medical Center Hamburg-Eppendorf (UKE); 🇩🇪 Hamburg, Germany

Local psychotherapists; 🇩🇪 Hamburg, Germany

Behavior therapy Falkenried MVZ GmbH; 🇩🇪 Hamburg, Germany

Scroll for more (8 remaining)