INTERBED: internet-based guided self-help for overweight and obese patients with full or subsyndromal binge eating disorder. A multicenter randomized controlled trial
1 Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Carl-Neuberg-Strasse 1, D-30625, Hannover, Germany
2 Department of Psychosomatic Medicine and Psychotherapy, LWL-University, Ruhr-University Bochum, Alexandrinenstrasse 1-3, D-44791, Bochum, Germany
3 Psychosomatic Medicine and Psychotherapy, Medical University Hospital Tübingen, Osianderstrasse 5, D-72076, Tübingen, Germany
4 Department of Clinical Psychology and Psychotherapy, University of Freiburg, Engelbergerstrasse 41, D-79085, Freiburg, Germany
5 Department of General Internal Medicine and Psychosomatics, Medical University Hospital Heidelberg, Im Neuenheimer Feld 410, D-69120, Heidelberg, Germany
6 Department of Psychosomatic Medicine and Psychotherapy, Medical University Hospital Erlangen, Schwabachanlage 6, D-91054, Erlangen, Germany
7 Department of Medical Informatics, Biometry and Epidemiology, University of Erlangen-Nuremberg, Waldstrasse 6, D-91054, Erlangen, Germany
8 NetUnion sarl, Ave de Villamont 19, CH-1005, Lausanne, Switzerland
9 Coordinating Centre for Clinical Trials (KKS), Philipps-University Marburg, Karl-von-Frisch-Strasse 4, Marburg, D-35043, Marburg, Germany
10 Department of Medical Psychology and Medical Sociology, Integrated Research and Treatment Center Adiposity Diseases, University of Leipzig Medical Center, Stephanstrasse 9C, D-04103, Leipzig, Germany
Trials 2012, 13:220 doi:10.1186/1745-6215-13-220Published: 21 November 2012
Binge eating disorder (BED) is a prevalent clinical eating disorder associated with increased psychopathology, psychiatric comorbidity, overweight and obesity, and increased health care costs. Since its inclusion in the DSM-IV, a few randomized controlled trials (RCTs) have suggested efficacy of book-based self-help interventions in the treatment of this disorder. However, evidence from larger RCTs is needed. Delivery of self-help through new technologies such as the internet should be investigated in particular, as these approaches have the potential to be more interactive and thus more attractive to patients than book-based approaches. This study will evaluate the efficacy of an internet-based guided self-help program (GSH-I) and cognitive-behavioral therapy (CBT), which has been proven in several studies to be the gold standard treatment for BED, in a prospective multicenter randomized trial.
The study assumes the noninferiority of GSH-I compared to CBT. Both treatments lasted 4 months, and maintenance of outcome will be assessed 6 and 18 months after the end of treatment. A total of 175 patients with BED and a body mass index between 27 and 40 kg/m2 were randomized at 7 centers in Germany and Switzerland. A 20% attrition rate was assumed. As in most BED treatment trials, the difference in the number of binge eating days over the past 28 days is the primary outcome variable. Secondary outcome measures include the specific eating disorder psychopathology, general psychopathology, body weight, quality of life, and self-esteem. Predictors and moderators of treatment outcome will be determined, and the cost-effectiveness of both treatment conditions will be evaluated.
The methodology for the INTERBED study has been detailed.
Although there is evidence that CBT is the first-line treatment for BED, it is not widely available. As BED is still a recent diagnostic category, many cases likely remain undiagnosed, and a large number of patients either receive delayed treatment or never get adequate treatment. A multicenter efficacy trial will give insight into the efficacy of a new internet-based guided self-help program and will allow a direct comparison to the evidence-based gold standard treatment of CBT in Germany.
Current Controlled Trials ISRCTN40484777
German Clinical Trial Register DRKS00000409