Internet-based guided self-help for overweight and obese patients with binge eating disorder
| ISRCTN | ISRCTN40484777 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40484777 |
| Protocol serial number | 01GV0601 |
| Sponsor | Federal Ministry for Education and Research (Bundeministerium für Bildung und Forschung [BMBF]) (Germany) |
| Funder | Bundesministerium für Bildung und Forschung |
- Submission date
- 04/05/2010
- Registration date
- 18/05/2010
- Last edited
- 04/08/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Department of Psychosomatic Medicine and Psychotherapy
University of Erlangen-Nuremberg
Schwabachanlage 6
Erlangen
91054
Germany
| Phone | +49 (0)9131 8535 928 |
|---|---|
| dezwaan.martina@mh-hannover.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre prospective randomised non-inferiority trial with two parallel arms |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Internet-based guided self-help for overweight and obese patients with binge eating disorder: a multicentre randomised controlled trial |
| Study acronym | INTERBED |
| Study objectives | Internet-based guided self-help will be equally effective in reducing the number of binge eating days as individual cognitive-behavioural therapy (CBT). |
| Ethics approval(s) | Ethics Board of the Faculty of Medicine, University of Erlangen-Nuremberg, 22/09/2009, ref: 4081 |
| Health condition(s) or problem(s) studied | Binge eating disorder |
| Intervention | 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. |
| Intervention type | Other |
| 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. |
| Key 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: |
| Completion date | 31/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 175 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2010 |
| Date of final enrolment | 31/03/2013 |
Locations
Countries of recruitment
- Germany
- Switzerland
Study participating centre
91054
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2017 | Yes | No | |
| Protocol article | protocol | 21/11/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/08/2017: Publication reference added.
