Condition category
Mental and Behavioural Disorders
Date applied
04/10/2011
Date assigned
11/11/2011
Last edited
19/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Prof Bernd Löwe

ORCID ID

Contact details

Universitätsklinikum Hamburg-Eppendorf
Institut für Psychosomatische Medizin und Psychotherapie
Martinistr. 52
Hamburg
D-20246
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The "Healthcare Network Anorexia and Bulimia Nervosa" Campaign - Focal project 2: Early diagnosis and treatment

Acronym

Study hypothesis

The establishment of a cross-sectoral, low-threshold ambulatory care unit, accompanied by the development of a directory for the treatment of eating disorders will lead to a reduction of the interval between the emergence of first symptoms of anorexia nervosa and the onset of a specific treatment in female patients diagnosed with typical or atypical anorexia nervosa who are treated for the first time in an inpatient, ambulatory or advisory setting.

Ethics approval

Ethics Committee of the Psychotherapist Chamber of the Free and Hanseatic City of Hamburg approved on 26th July 2011

Study design

Feasibility study pre-post-design with independent samples

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Anorexia nervosa (typical / atypical)

Intervention

1. Center for Early Diagnosis: Psychological/medical diagostics, one-to-one individual counselling for both patients, relatives and professionals, therapeutical groups, psychoeducational programs, education events for specialist personnel
2. On-line tratement directory: General information about the subject of eating disorders for both patients, relatives and expert personnel, screening instruments, recommendations for subsequent guideline-based treatment

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Interval between the emergence of first symptoms of anorexia nervosa and the onset of a specific treatment

Secondary outcome measures

1. Psychopathology (somatoform, depressive and anxiety-related symptoms; PHQ-15, PHQ-9, GAD-7)
2. Health outcome (EQ-5D)
3. Personality accentuation (PSSI-K)
4. Ontogenetic risk factors for the development of eating disorders (PPR-7)

Overall trial start date

01/10/2011

Overall trial end date

31/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Informed consent (if patient is aged under 16 the additional consent of parents / guardians is required)
2. Diagnosis of typical or atypical anorexia nervosa
3. Female gender
4. Age between 12 and 39
5. Center of vital interests in the metropolitan area of Hamburg
6. Integration with a counselling center, psychotherapeutic practice oder in-/outpatient clinic in the metropolitan area of Hamburg
7. First-line treatment / first contact (i.e. initiation of treatment in the course of the past 12 months)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

To be screened: 1.800, to be recruited: 600, to be evaluated: 300

Participant exclusion criteria

1. Deficiencies in the command of the German language
2. Severe organic or mental ailments impeding a participation in the study
3. For patients recruited for the post-survey: participation in the pre-survey

Recruitment start date

01/10/2011

Recruitment end date

31/03/2012

Locations

Countries of recruitment

Germany

Trial participating centre

Universitätsklinikum Hamburg-Eppendorf
Hamburg
D-20246
Germany

Sponsor information

Organisation

Federal Ministry of Education and Research [Bundesministerium für Bildung und Forschung] (Germany)

Sponsor details

Dienstsitz Berlin
Hannoversche Straße 28-30
Berlin
D-10115
Germany

Sponsor type

Government

Website

http://www.bmbf.de/en/

Funders

Funder type

Government

Funder name

German Federal Ministry of Education and Research (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in http://www.ncbi.nlm.nih.gov/pubmed/25404427

Publication citations

Additional files

Editorial Notes

19/10/2015: Publication reference added.