Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
01GV0604
Study information
Scientific title
Internet-based relapse prevention for Eating Disorders following inpatient treatment: randomised controlled trial for Anorexia Nervosa
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(s)
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
Study setting(s)
Not specified
Study 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
Primary outcome measure
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 study start date
01/01/2007
Overall study end date
31/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female
2. More than 16 years
3. Diagnosis anorexia nervosa
4. Successful inpatient therapy
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
Included: 258, completers: 180
Total final enrolment
258
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2012 | 22/05/2019 | Yes | No |
| Results article | results | 30/07/2013 | 22/05/2019 | Yes | No |
| Results article | results | 08/02/2015 | 22/05/2019 | Yes | No |