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Approach Bias Modification Training In Bulimia Nervosa and Binge Eating Disorder: A Randomised Controlled Pilot Trial

Organizational Data

DRKS-ID:
DRKS00010231
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2016-03-24
Last update in DRKS:
2019-03-11
Registration type:
Retrospective

Acronym/abbreviation of the study

ABBA

URL of the study

No Entry

Brief summary in lay language

The central aim of this pilot study is to examine whether 10 sessions of a specifically tailored computerised training (termed "approach bias modification") can reduce the core syptoms of bulimia nervosa and binge eating disorder. During this training, participants learn to make avoidance movements in response to images of high calorie food. In order to examine the efficacy of the training, we compare this training to a sham version in which participants are not trained to make avoidance movements towards food pictures. Additionally, we will investigate whether this training reduces food craving and food intake as well as the way how participants process visual food cues. Finally, we will assess treatment acceptance.

Brief summary in scientific language

The principle aim of this randomised sham-controlled pilot trial is to examine whether a specifically tailored computerised cognitive bias modification (CBM) training (termed "approach bias modification") can reduce the number of subjective and objective binge eating episodes and other core bulimic symptoms in patients with bulimia nervosa or binge eating disorder. Participants will be randomly assigned to either 10 sessions of real CBM or 10 sessions of sham CBM (over a 4 weeks period). In the real CBM condition, participants will be trained to repeatedly show avoidance behaviour (via a joystick) in response to pictures of high calorie food. In contrast, the sham condition requires participants to make an equal number of approach and avoidance movements in response to the food images. In addition, we will examine whether (compared to the sham condition) real CBM alters trait-level and cue-elicited state-level food craving as well as approach and attentional bias towards food cues and actual food intake (in the laboratory). Finally, we will also examine treatment acceptance taking the attrition rate and feedback by the participants into account.

Health condition or problem studied

ICD10:
F50.2 - Bulimia nervosa
ICD10:
F50.9 - Eating disorder, unspecified
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 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.
Arm 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.

Endpoints

Primary outcome:
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:
(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.

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Placebo
Phase:
II
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
  • Assessor
  • Patient/subject

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
  • United Kingdom
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London London
  • University medical center Klinik für Allgemeine Innere Medizin und Psychosomatik, Zentrum für Psychosoziale Medizin, Universitätsklinik Heidelberg Heidelberg

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2015-12-18
Planned study completion date:
No Entry
Actual Study Completion Date:
2017-09-01
Target Sample Size:
54
Final Sample Size:
56

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional 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)

Addresses

Primary Sponsor

Klinik für Psychosomatische Medizin und Psychotherapie, Medizinische Fakultät, Heinrich Heine Universität, Düsseldorf, Deutschland
Prof. Hans-Christoph Friederich
Moorenstrasse 5
40225 Düsseldorf
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für Allgemeine Innere Medizin und Psychosomatik, Universitätsklinik Heidelberg
Dr. Timo Brockmeyer
Im Neuenheimer Feld 410
69120 Heidelberg
Germany
Telephone:
06221-5637153
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Klinik für Allgemeine Innere Medizin und Psychosomatik, Universitätsklinik Heidelberg
Dr. Timo Brockmeyer
Im Neuenheimer Feld 410
69120 Heidelberg
Germany
Telephone:
06221-5637153
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Klinik für Allgemeine Innere Medizin und Psychosomatik, Universitätsklinik Heidelberg
Dr. Timo Brockmeyer
Im Neuenheimer Feld 410
69120 Heidelberg
Germany
Telephone:
06221-5637153
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)

Schweizer Anorexia Nervosa Stiftung
Klünenfeldstrasse 22
4127 Birsfelden
Switzerland
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Medizinischen Fakultät Heidelberg
Alte Glockengießerei 11/1
69115 Heidelberg
Germany
Telephone:
+49-6221-338220
Fax:
+49-6221-3382222
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2014-02-14
Ethics committee number:
S-100/2014
Vote of the Ethics Committee:
Approved
Date of the vote:
2014-04-16

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
Brockmeyer T, Friederich H-C, Küppers C, Chowdhury S, Harms L, Simmonds J, Gordon G, Potterton R, Schmidt U (2019). Approach bias modification training in bulimia nervosa and binge eating disorder: a pilot randomized controlled trial. International Journal of Eating Disorders, DOI: 10.1002/eat.23024
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry