Condition category
Mental and Behavioural Disorders
Date applied
04/05/2010
Date assigned
18/05/2010
Last edited
23/11/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ednet-essstoerungen.de/

Contact information

Type

Scientific

Primary contact

Prof Martina de Zwaan

ORCID ID

Contact details

Department of Psychosomatic Medicine and Psychotherapy
University of Erlangen-Nuremberg
Schwabachanlage 6
Erlangen
91054
Germany
+49 (0)9131 8535 928
dezwaan.martina@mh-hannover.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01GV0601

Study information

Scientific title

Internet-based guided self-help for overweight and obese patients with Binge Eating Disorder: a multicentre randomised controlled trial

Acronym

INTERBED

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).

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/07/2010

Overall trial end date

31/03/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

175

Participant 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

Recruitment start date

01/07/2010

Recruitment end date

31/03/2013

Locations

Countries of recruitment

Germany, Switzerland

Trial participating centre

Department of Psychosomatic Medicine and Psychotherapy
Erlangen
91054
Germany

Sponsor information

Organisation

Federal Ministry for Education and Research (Bundeministerium für Bildung und Forschung [BMBF]) (Germany)

Sponsor details

Projektträger im Deutsches Zentrum für Luft- und Raumfahrt (DLR) e.V.
Gesundheitsforschung
Heinrich-Konen-Strasse 1
Bonn
53227
Germany
+49 (0)228 3821686
Thomas.Becker@dlr.de

Sponsor type

Not defined

Website

http://www.gesundheitsforschung-bmbf.de

Funders

Funder type

Government

Funder name

Federal Ministry for Education and Research (Bundeministerium für Bildung und Forschung [BMBF]) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23171536

Publication citations

  1. Protocol

    de Zwaan M, Herpertz S, Zipfel S, Tuschen-Caffier B, Friederich HC, Schmidt F, Gefeller O, Mayr A, Lam T, Schade-Brittinger C, Hilbert A, INTERBED: internet-based guided self-help for overweight and obese patients with full or subsyndromal binge eating disorder. A multicenter randomized controlled trial., Trials, 2012, 13, 220, doi: 10.1186/1745-6215-13-220.

Additional files

Editorial Notes