Internet-based relapse prevention for Eating Disorders following inpatient treatment: randomised controlled trial for Anorexia Nervosa

ISRCTN	ISRCTN20173615
DOI	https://doi.org/10.1186/ISRCTN20173615
Secondary identifying numbers	01GV0604

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Manfred Fichter
Scientific

Klinik Roseneck
Am Roseneck 6
Prien am Chiemsee
83209
Germany

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
Scientific title	Internet-based relapse prevention for Eating Disorders following inpatient treatment: randomised controlled trial for Anorexia Nervosa
Study acronym	EDNET 3 AN
Study objectives	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).
Health condition(s) or problem(s) studied	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
Completion date	31/12/2009

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Included: 258, completers: 180
Total final enrolment	258
Key inclusion criteria	1. Female 2. More than 16 years 3. Diagnosis anorexia nervosa 4. Successful inpatient therapy
Key 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
Date of first enrolment	01/01/2007
Date of final enrolment	31/12/2009

Klinik Roseneck

Prien am Chiemsee
83209
Germany

Medical-Psychosomatic Hospital Klinik Roseneck (Medizinisch-Psychosomatische Klinik Roseneck) (Germany)
Hospital/treatment centre

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

"ROR"	https://ror.org/007ztdc30

Government

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

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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

22/05/2019: Publication reference and total final enrolment added.