Facilitators and Barriers in Anorexia Nervosa - Treatment Initiation

Last updated: November 10, 2020
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anorexia

Vomiting

Treatment

N/A

Clinical Study ID

NCT03713541
LO 766/16-1m; GU 156
  • Ages > 14
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 450
Study Start date:
May 01, 2018
Estimated Completion Date:
April 30, 2022

Study 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.

Connect with a study center

  • Schön Clinic Roseneck

    Prien am Chiemsee, Bavaria 83209
    Germany

    Active - Recruiting

  • Schön Clinic Bad Bramstedt

    Bad Bramstedt, Schleswig-Holstein 24576
    Germany

    Active - Recruiting

  • Curtius-Clinic, Specialist Clinic for Psychosomatics and Psychotherapeutic Medicine

    Bad Malente, Schleswig-Holstein 23714
    Germany

    Active - Recruiting

  • Schön Clinic Bad Arolsen

    Bad Arolsen, 34454
    Germany

    Active - Recruiting

  • Clinic Lüneburger Heide

    Bad Bevensen, 29549
    Germany

    Active - Recruiting

  • MediClin Seepark Clinic

    Bad Bodenteich, 29389
    Germany

    Active - Recruiting

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

    Cuxhaven, 27472
    Germany

    Active - Recruiting

  • Asklepios Clinic Nord - Ochsenzoll

    Hamburg, 22419
    Germany

    Active - Recruiting

  • Behavior therapy Falkenried MVZ GmbH

    Hamburg, 20251
    Germany

    Active - Recruiting

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

    Hamburg, 20246
    Germany

    Site Not Available

  • Department of Psychosomatic Medicine and Psychotherapy, Asklepios West Clinic Hamburg

    Hamburg, 20559
    Germany

    Active - Recruiting

  • Institute for Behavior Therapy Education Hamburg (IVAH)

    Hamburg, 22085
    Germany

    Site Not Available

  • Local psychotherapists

    Hamburg, 20246
    Germany

    Site Not Available

  • Schön Clinic Eilbek

    Hamburg, 22081
    Germany

    Active - Recruiting

  • Schön Clinic Hamburg Eilbek

    Hamburg, 22081
    Germany

    Active - Recruiting

  • VT Falkenried Training and Education

    Hamburg, 20251
    Germany

    Active - Recruiting

  • University Clinic Regensburg

    Regensburg, 93053
    Germany

    Active - Recruiting

  • Evangelic hospital Ginsterhof HmbH

    Rosengarten, 21224
    Germany

    Active - Recruiting

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