Condition category
Mental and Behavioural Disorders
Date applied
08/11/2006
Date assigned
04/01/2007
Last edited
19/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Manfred Fichter

ORCID ID

Contact details

Klinik Roseneck
Am Roseneck 6
Prien am Chiemsee
83209
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01GV0604

Study information

Scientific title

Acronym

EDNET 3 AN

Study hypothesis

Evaluation of the efficacy of an internet based relapse prevention program in anorexia nervosa after inpatient treatment.

Ethics approval

Approval was obtained from the ethics board of the "Bayerische Landesaerztekammer" (Bavarian General Medical Council) on August 2, 2006 (reference number: 06034).

Study design

Multi-centre, prospective, randomised superiority trial with two parallel arms each

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Anorexia Nervosa

Intervention

Experimental intervention:
Application of a behaviourally oriented Relapse Prevention Program (RPP) via internet with chat room, SMS and e-mail support and feed-back.

Control intervention:
Treatment As Usual (TAU) and internet newsletter.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Difference between body mass index at the end of the treatment (nine months) and at randomisation

Secondary outcome measures

Explorative measures of psychopathology to investigate the time course and to support the clinical claim

Overall trial start date

01/01/2007

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female
2. More than 16 years
3. Diagnosis anorexia nervosa
4. Successful inpatient therapy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Included: 258, completers: 180

Participant exclusion criteria

1. Mental or somatic disability prohibiting participation in study
2. Acute psychosis
3. Chronic organic or schizophrenic psychosis
4. Severe suicidal ideation/behaviour

Recruitment start date

01/01/2007

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Klinik Roseneck
Prien am Chiemsee
83209
Germany

Sponsor information

Organisation

Medical-Psychosomatic Hospital Klinik Roseneck (Medizinisch-Psychosomatische Klinik Roseneck) (Germany)

Sponsor details

Afiliated with the Ludwig-Maximilians-University (LMU) Munich
Am Roseneck 6
Prien am Chiemsee
83209
Germany

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

German Federal Ministry for Education and Research (Bundesministerium für Bildung und Forschung) (Germany) (ref: 01 GV 0604)

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

Publication citations

Additional files

Editorial Notes