Anorexia NervosaFABIANANCT03713541
Facilitators and Barriers in Anorexia Nervosa - Treatment Initiation
An observational study of Anorexia Nervosa and Feeding and Eating Disorders of Childhood, run by Universitätsklinikum Hamburg-Eppendorf at 18 sites in Germany.
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… Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Anorexia Nervosa, Feeding and Eating Disorders of Childhood
- How many people
- 450 participants
- Where
- 18 sitesGermany
- Study dates
- 1 May 2018to Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
- in AN patients aged 14 to 15 years: parents ; in AN patients aged 16 years and over: parents or other significant carer
Show all 12Show fewer
- 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
Who cannot join
- Insufficient language skills
- Serious organic or psychiatric illnesses
- Acute suicidality
- Significant caregiver
- Physician
- Insufficient language skills
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Germany18 sites, 17 recruiting
- Recruiting
Schön Clinic Bad Arolsen
Bad Arolsen, 34454
M Seidel, Dr. med.
- Recruiting
Clinic Lüneburger Heide
Bad Bevensen, 29549
W Wünsch-Leiteritz, Dr. med.
- Recruiting
Schön Clinic Bad Bramstedt
Bad Bramstedt, Schleswig-Holstein, 24576
Bernhard Osen, Dr.
- Recruiting
MediClin Seepark Clinic
Bodenteich, 29389
Schwennen, Dr
- Recruiting
Timmermann & Partner, Medical care center for physical and mental health
Cuxhaven, 27472
S Rieper
- Active, not recruiting
Department of Child and Adolescent Psychiatry of the University Medical Center Hamburg-Eppendorf (UKE)
Hamburg, 20246
- Enrolling by invitation
Local psychotherapists
Hamburg, 20246
- Recruiting
Behavior therapy Falkenried MVZ GmbH
Hamburg, 20251
Kiki Peter
- Recruiting
VT Falkenried Training and Education
Hamburg, 20251
Roman Wessels
- Recruiting
Department of Psychosomatic Medicine and Psychotherapy, Asklepios West Clinic Hamburg
Hamburg, 20559
Helge Fehrs, Dr.
- Recruiting
Schön Clinic Eilbek
Hamburg, 22081
Rebecca Albrecht, Dr.
- Recruiting
Schön Clinic Hamburg Eilbek
Hamburg, 22081
Rebecca Albrecht, Dr.
- Enrolling by invitation
Institute for Behavior Therapy Education Hamburg (IVAH)
Hamburg, 22085
- Recruiting
Asklepios Clinic Nord - Ochsenzoll
Hamburg, 22419
Silke Hagena, Dipl.-Psych.
- Recruiting
Curtius-Clinic, Specialist Clinic for Psychosomatics and Psychotherapeutic Medicine
Malente, Schleswig-Holstein, 23714
Silke Kleinschmidt, Dr.
- Recruiting
Schön Clinic Roseneck
Prien am Chiemsee, Bavaria, 83209
Ulrich Voderholzer, Prof. Dr.
- Recruiting
University Clinic Regensburg
Regensburg, 93053
Rumoald Brunner, Prof. Dr.
- Recruiting
Evangelic hospital Ginsterhof HmbH
Rosengarten, 21224
Ute-Christine Haberer, Dr. med.
About this study
Official title: Identification of Beneficial and Inhibitory Factors for Treatment in Patients With Anorexia Nervosa: A Pathway to Effective Secondary Prevention and Prognostic Improvement
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.
Read the 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.
- Being tested
- No intervention
- Keywords
- 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
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders of Childhood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Survey during normal supply.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention | |
| 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. Receives: Other: No intervention | |
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from date of study enrolment up to 12 weeks
Secondary outcomes (1)
Duration of first contact (DUC in month)
DUC is assessed cross-sectional (retrospectively) using standardized interviews and paper-and-pencil questionnaires.
Measured: from date of study enrolment up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start1 May 2018
- Primary completionAug 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Prof. Dr. Antje Gumz, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Antje Gumz, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-EppendorfBernd Loewe, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713541
- Sponsor's protocol ID
- LO 766/16-1m; GU 156
- Acronym
- FABIANA
- Status last verified
- Nov 2020
- First submitted
- 23 Aug 2018
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34732246Kastner 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.
PubMed 33640028Kastner 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.
PubMed 31631825
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Beneficial and Inhibitory Factors for Treatment in Patients With Anorexia Nervosa: A Pathway to Effective Secondary Prevention and Prognostic Improvement
- ClinicalTrials.gov ID
- NCT03713541
- Acronym / sponsor ID
- FABIANA / LO 766/16-1m; GU 156
- Keywords
- Anorexia nervosa [MeSH], Feeding and Eating Disorders [MeSH], women, youth, adolescent, duration of untreated illness (DUI), time-to-treatment [MeSH], facilitators
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 1 May 2018 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Anorexia nervosa (AN) | – | Other: No interventionFemale 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. |
| Carers of patients with AN | – | Other: No interventionSignificant 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. |
| Physicians of patients with AN | – | Other: No interventionResident general practitioner, pediatrician, internist or gynecologist with at least one medical patient contact within the last 12 months. No intervention. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- Insufficient language skills
- Serious organic or psychiatric illnesses
- Acute suicidality
- Significant caregiver
- Physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionSurvey during normal supply. | Other | Carers of patients with AN, Patients with Anorexia nervosa (AN), Physicians of patients with AN |
Primary outcome
Duration of untreated illness (DUI in months)
Time frame: 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.
1 secondary outcome
Duration of first contact (DUC in month)
Time frame: from date of study enrolment up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Derived from this study: PubMed 34732246Reuter 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.
- Derived from this study: PubMed 33640028Kastner 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.
- Derived from this study: PubMed 31631825Kastner 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antje Gumz, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
Bernd Loewe, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Feeding and Eating Disorders of Childhood, run by Universitätsklinikum Hamburg-Eppendorf at 18 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angelika Weigel, Dr. (+4915222827125, a.weigel@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of untreated illness (DUI in months) (time frame: from date of study enrolment up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03713541, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.