Internet-based guided self-help for overweight and obese patients with binge eating disorder
| ISRCTN | ISRCTN40484777 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40484777 |
| Secondary identifying numbers | 01GV0601 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Martina de Zwaan
Scientific
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
| Study design | Multicentre prospective randomised non-inferiority trial with two parallel arms |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 measures | 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 |
| Overall study start date | 01/07/2010 |
| Completion date | 31/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
University of Erlangen-Nuremberg
Erlangen
91054
Germany
91054
Germany
Sponsor information
Federal Ministry for Education and Research (Bundeministerium für Bildung und Forschung [BMBF]) (Germany)
Not defined
Not defined
Projektträger im Deutsches Zentrum für Luft- und Raumfahrt (DLR) e.V.
Gesundheitsforschung
Heinrich-Konen-Strasse 1
Bonn
53227
Germany
| Phone | +49 (0)228 3821686 |
|---|---|
| Thomas.Becker@dlr.de | |
| Website | http://www.gesundheitsforschung-bmbf.de |
"ROR" |
https://ror.org/04pz7b180 |
Funders
Funder type
Government
Bundesministerium für Bildung und Forschung
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 21/11/2012 | Yes | No | |
| Results article | results | 01/10/2017 | Yes | No |
Editorial Notes
04/08/2017: Publication reference added.
