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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: German Clinical Trials Register
Last refreshed on: 8 April 2024
Main ID:  DRKS00010231
Date of registration: 24/03/2016
Prospective Registration: No
Primary sponsor: Klinik für Psychosomatische Medizin und Psychotherapie, Medizinische Fakultät, Heinrich Heine Universität, Düsseldorf, Deutschland
Public title: Approach Bias Modification Training In Bulimia Nervosa and Binge Eating Disorder: A Randomised Controlled Pilot Trial
Scientific title: Approach Bias Modification Training In Bulimia Nervosa and Binge Eating Disorder: A Randomised Controlled Pilot Trial - ABBA
Date of first enrolment: 18/12/2015
Target sample size: 54
Recruitment status: Complete
URL:  http://drks.de/search/en/trial/DRKS00010231
Study type:  interventional
Study design:  Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: placebo; Assignment: parallel; Study design purpose: treatment  
Phase:  2
Countries of recruitment
Germany United Kingdom
Contacts
Name: Timo    Brockmeyer
Address:  Im Neuenheimer Feld 410 69120 Heidelberg Germany
Telephone: 06221-5637153
Email: timo.brockmeyer@med.uni-heidelberg.de
Affiliation:  Klinik für Allgemeine Innere Medizin und Psychosomatik, Universitätsklinik Heidelberg
Name: Timo    Brockmeyer
Address:  Im Neuenheimer Feld 410 69120 Heidelberg Germany
Telephone: 06221-5637153
Email: timo.brockmeyer@med.uni-heidelberg.de
Affiliation:  Klinik für Allgemeine Innere Medizin und Psychosomatik, Universitätsklinik Heidelberg
Key inclusion & exclusion criteria
Inclusion criteria: (a) age 18 years or above

(b) DSM-V diagnosis of Bulimia Nervosa or Binge Eating Disorder

Exclusion criteria: (a) age under 18 years

(b) medical (e.g. major electrolyte abnormalities) or psychiatric (e.g. acute suicidality) instability

(c) current or lifetime diagnosis of substance dependence, psychosis, bipolar disorder, ADHD, or borderline personality disorder

(d) psychotropic medication other than selective serotonin reuptake inhibitors (patients have to be on a stable medication, i.e. at least 14 days, of SRRI during participation in the trial)


Age minimum: 18 Years
Age maximum: None
Gender: All
Health Condition(s) or Problem(s) studied
F50.2
F50.9

F50.2
F50.9
Bulimia nervosa
Eating disorder, unspecified
Intervention(s)
Group 1: real CBM (approach bias modification training): In an implicit learning paradigm, participants repeatedly make avoidance movements (via a joystick) in response to pictures of high calorie food (which makes the pictures shrink on the computer screen). The training involves 10 sessions over a period of 4 weeks, one sessions lasts 15 minutes.
Group 2: sham CBM: Participants equally often make approach and avoidance movements in response to pictures of high calorie food (via a joystick which increases/decreases the pictures on the computer screen). Equivalent to the real CBM condition, this sham version involve 10 sessions (15 minutes each) over a period of 4 weeks.
Primary Outcome(s)
Number of subjective and objective binge eating attacks and global eating disorder psychopathology during the previous 2 months prior and after the intervention.
Secondary Outcome(s)
(1) approach bias towards visual food cues prior/after the intervention.

(2) attentional bias towards visueal food cues prior/after the intervention.

(3) trait food craving prior/after the intervention.

(4) state levels of cue-elicited food craving prior/after the intervention.

(5) food intake in the laboratory prior/after the intervention.

(6) treatment acceptance.
Secondary ID(s)
Source(s) of Monetary Support
Schweizer Anorexia Nervosa Stiftung
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 16/04/2014
Contact:
ethikkommission-I@med.uni-heidelberg.de
Ethikkommission der Medizinischen Fakultät Heidelberg
+49-6221-338220
ethikkommission-I@med.uni-heidelberg.de
Results
Results available:
Date Posted:
Date Completed: 01/09/2017
URL: http://drks.de/search/en/trial/DRKS00010231#studyResults
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