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Internet-based guided self-help for overweight and obese patients with Binge Eating Disorder
DOI 10.1186/ISRCTN40484777
ClinicalTrials.gov identifier
EudraCT number
Public title Internet-based guided self-help for overweight and obese patients with Binge Eating Disorder
Scientific title Internet-based guided self-help for overweight and obese patients with Binge Eating Disorder: a multicentre randomised controlled trial
Serial number at source 01GV0601
Study hypothesis Internet-based guided self-help will be equally effective in reducing the number of binge eating days as individual cognitive-behavioural therapy (CBT).
Lay summary Not provided at time of registration
Ethics approval Ethics Board of the Faculty of Medicine, University of Erlangen-Nuremberg, approved on the 22nd September 2009 (ref: 4081)
Study design Multicentre prospective randomised non-inferiority trial with two parallel arms
Countries of recruitment Germany, Switzerland
Disease/condition/study domain Binge eating disorder
Participants - inclusion criteria 1. Binge eating disorder (BED) according to DSM-IV criteria or subsyndromal BED (lacking one diagnostic criterion)
2. Age 18 years or older, either sex
3. Body mass index (BMI) between 27 and 40 kg/m^2
4. Signed consent form
Participants - exclusion criteria 1. Bulimia nervosa
2. Current substance abuse
3. Current suicidal ideation
4. Psychotic disorder
5. Mania
6. Ongoing psychotherapy
7. Medical conditions (type I diabetes or thyroid problems) that influence weight or eating
8. Pregnancy and lactation
Anticipated start date 01/07/2010
Anticipated end date 31/03/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 175
Interventions Participants will be randomised to:
1. GSH: internet-based guided-self-help for BED. The program contains 11 modules delivered within 4 months. During this time the participants will be contacted weekly via e-mail, discussing progress or potential problems with a therapeutic coach.
2. CBT: 20 sessions of individual cognitive-behavioral therapy will be delivered over 4 months. A published manual will be used.
Primary outcome measure(s) Difference of the number of binge eating days over the last 28 days. Number of days with binge eating episodes will be measured with the German version of the Eating Disorder Examination, a semi-structured interview which is regarded as the gold standard assessment of eating pathology. Comparisons will be done between baseline (randomisation), mid-treatment (2 months after randomisation) and the end of treatment (4 months after randomisation). In addition, maintenance of treatment outcome will be assessed 6 months after treatment completion in the two intervention groups.
Secondary outcome measure(s) Measured at baseline (randomisation), mid-treatment (2 months after randomisation), the end of treatment (4 months after randomisation) and 6 months follow-up:
1. Associated eating-disorder psychopathology
2. General psychopathology, psychiatric disorders
3. Severity of depression
4. Self-esteem
5. Quality of life
6. Impulsivity, impulse control
7. Weight, BMI
8. Process measure: working alliance inventory, eating behaviour, assessed on a weekly basis
9. Health economy
Sources of funding Federal Ministry for Education and Research (Bundeministerium für Bildung und Forschung [BMBF]) (Germany)
Trial website http://www.ednet-essstoerungen.de/
Publications 1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23171536
Contact name Prof  Martina  de Zwaan
  Address Department of Psychosomatic Medicine and Psychotherapy
University of Erlangen-Nuremberg
Schwabachanlage 6
  City/town Erlangen
  Zip/Postcode 91054
  Country Germany
  Tel +49 (0)9131 8535 928
  Fax +49 (0)9131 8534 153
  Email dezwaan.martina@mh-hannover.de
Sponsor Federal Ministry for Education and Research (Bundeministerium für Bildung und Forschung [BMBF]) (Germany)
  Address Projektträger im Deutsches Zentrum für Luft- und Raumfahrt (DLR) e.V.
Heinrich-Konen-Strasse 1
  City/town Bonn
  Zip/Postcode 53227
  Country Germany
  Tel +49 (0)228 3821686
  Fax +49 (0)228 3821 257
  Email Thomas.Becker@dlr.de
  Sponsor website: http://www.gesundheitsforschung-bmbf.de
Date applied 04/05/2010
Last edited 23/11/2012
Date ISRCTN assigned 18/05/2010
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