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Trial record 4 of 287501 for:    ALL

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

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ClinicalTrials.gov Identifier: NCT03713541
Recruitment Status : Enrolling by invitation
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Prof. Dr. Antje Gumz, 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.


Condition or disease Intervention/treatment
Anorexia Nervosa Feeding and Eating Disorders of Childhood 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
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Identification of Beneficial and Inhibitory Factors for Treatment in Patients With Anorexia Nervosa: A Pathway to Effective Secondary Prevention and Prognostic Improvement
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2020

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.




Primary Outcome Measures :
  1. Duration of untreated illness (DUI in months) [ Time Frame: from date of study enrolement up to 12 weeks ]
    DUI (defined as the time between occurance of first symptoms and treatment) is assessed retrospectively and cross-sectional using standardized interviews and paper-and-pencil questionnaires.


Secondary Outcome Measures :
  1. Duration of first contact (DUC in month) [ Time Frame: from date of study enrolement up to 12 weeks ]
    DUC is assessed cross-sectional (retrospectively) using standardized interviews and paper-and-pencil questionnaires.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713541


Locations
Germany
Schön Clinic Roseneck
Prien am Chiemsee, Bavaria, Germany, 83209
Schön Clinic Bad Bramstedt
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
Curtius-Clinic, Specialist Clinic for Psychosomatics and Psychotherapeutic Medicine
Bad Malente, Schleswig-Holstein, Germany, 23714
Department of Chiuld and Adolescent Psychiatry of the University Medical Center Hamburg-Eppendorf (UKE)
Hamburg, Germany, 20246
Local psychotherapists
Hamburg, Germany, 20246
Behavior therapy Falkenried MVZ GmbH
Hamburg, Germany, 20251
VT Falkenried Training and Education
Hamburg, Germany, 20251
Department of Psychosomatic Medicine and Psychotherapy, Asklepios West Clinic Hamburg
Hamburg, Germany, 20559
Schön Clinic Hamburg Eilbek
Hamburg, Germany, 22081
Institute for Behavior Therapy Education Hamburg (IVAH)
Hamburg, Germany, 22085
Asklepios Clinic Nord - Ochsenzoll
Hamburg, Germany, 22419
University Clinic Regensburg
Regensburg, Germany, 93053
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
German Research Foundation
Investigators
Principal Investigator: Antje Gumz, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf
Principal Investigator: Bernd Loewe, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf

Responsible Party: Prof. Dr. Antje Gumz, Principal Investigator, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03713541     History of Changes
Other Study ID Numbers: LO 766/16-1m; GU 156
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr. Antje Gumz, Universitätsklinikum Hamburg-Eppendorf:
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

Additional relevant MeSH terms:
Feeding and Eating Disorders
Anorexia
Anorexia Nervosa
Feeding and Eating Disorders of Childhood
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms