Facilitators and Barriers in Anorexia Nervosa - Treatment Initiation
NCT ID: NCT03713541
Last Updated: 2020-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
450 participants
OBSERVATIONAL
2018-05-01
2022-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
No intervention
Survey during normal supply.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No intervention
Survey during normal supply.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
* 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
* Serious organic or psychiatric illnesses
* Acute suicidality
Significant caregiver
Physician
\- Insufficient language skills
14 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
German Research Foundation
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Dr. Antje Gumz
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Antje Gumz, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Bernd Loewe, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Malente, Schleswig-Holstein, Germany
Schön Clinic Bad Arolsen
Bad Arolsen, , Germany
Clinic Lüneburger Heide
Bad Bevensen, , Germany
MediClin Seepark Clinic
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
VT Falkenried Training and Education
Hamburg, , Germany
Department of Psychosomatic Medicine and Psychotherapy, Asklepios West Clinic Hamburg
Hamburg, , Germany
Schön Clinic Eilbek
Hamburg, , Germany
Schön Clinic Hamburg Eilbek
Hamburg, , Germany
Institute for Behavior Therapy Education Hamburg (IVAH)
Hamburg, , Germany
Asklepios Clinic Nord - Ochsenzoll
Hamburg, , Germany
University Clinic Regensburg
Regensburg, , Germany
Evangelic hospital Ginsterhof HmbH
Rosengarten, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ulrich Voderholzer, Prof. Dr.
Role: primary
Bernhard Osen, Dr.
Role: primary
Silke Kleinschmidt, Dr.
Role: primary
M Seidel, Dr. med.
Role: primary
W Wünsch-Leiteritz, Dr. med.
Role: primary
Schwennen, Dr
Role: primary
S Rieper
Role: primary
Kiki Peter
Role: primary
Roman Wessels
Role: primary
Helge Fehrs, Dr.
Role: primary
Rebecca Albrecht, Dr.
Role: primary
Rebecca Albrecht, Dr.
Role: primary
Silke Hagena, Dipl.-Psych.
Role: primary
Rumoald Brunner, Prof. Dr.
Role: primary
Ute-Christine Haberer, Dr. med.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LO 766/16-1m; GU 156
Identifier Type: -
Identifier Source: org_study_id