Facilitators and Barriers in Anorexia Nervosa - Treatment Initiation

Anorexia Nervosa Clinical Trial

— FABIANA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03713541
• Other study ID #: LO 766/16-1m; GU 156
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: April 2022

Study information

• Verified date: November 2020
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Angelika Weigel, Dr.
• Phone: +4915222827125
• Email: a.weigel[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: April 2022
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Feeding and Eating Disorders
• Feeding and Eating Disorders of Childhood

Intervention

Other:
• No intervention
Survey during normal supply.

Locations

Country	Name	City	State
Germany	Schön Clinic Bad Arolsen	Bad Arolsen
Germany	Clinic Lüneburger Heide	Bad Bevensen
Germany	MediClin Seepark Clinic	Bad Bodenteich
Germany	Schön Clinic Bad Bramstedt	Bad Bramstedt	Schleswig-Holstein
Germany	Curtius-Clinic, Specialist Clinic for Psychosomatics and Psychotherapeutic Medicine	Bad Malente	Schleswig-Holstein
Germany	Timmermann & Partner, Medical care center for physical and mental health	Cuxhaven
Germany	Asklepios Clinic Nord - Ochsenzoll	Hamburg
Germany	Behavior therapy Falkenried MVZ GmbH	Hamburg
Germany	Department of Child and Adolescent Psychiatry of the University Medical Center Hamburg-Eppendorf (UKE)	Hamburg
Germany	Department of Psychosomatic Medicine and Psychotherapy, Asklepios West Clinic Hamburg	Hamburg
Germany	Institute for Behavior Therapy Education Hamburg (IVAH)	Hamburg
Germany	Local psychotherapists	Hamburg
Germany	Schön Clinic Eilbek	Hamburg
Germany	Schön Clinic Hamburg Eilbek	Hamburg
Germany	VT Falkenried Training and Education	Hamburg
Germany	Schön Clinic Roseneck	Prien am Chiemsee	Bavaria
Germany	University Clinic Regensburg	Regensburg
Germany	Evangelic hospital Ginsterhof HmbH	Rosengarten

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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