Main
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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:
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German Clinical Trials Register |
Last refreshed on:
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8 April 2024 |
Main ID: |
DRKS00010231 |
Date of registration:
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24/03/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Approach Bias Modification Training In Bulimia Nervosa and Binge Eating Disorder: A Randomised Controlled Pilot Trial
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Scientific title:
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Approach Bias Modification Training In Bulimia Nervosa and Binge Eating Disorder: A Randomised Controlled Pilot Trial - ABBA |
Date of first enrolment:
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18/12/2015 |
Target sample size:
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54 |
Recruitment status: |
Complete |
URL:
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http://drks.de/search/en/trial/DRKS00010231 |
Study type:
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interventional |
Study design:
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Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: placebo; Assignment: parallel; Study design purpose: treatment
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Phase:
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2
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Countries of recruitment
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Germany
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United Kingdom
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Contacts
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Name:
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Timo
Brockmeyer |
Address:
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Im Neuenheimer Feld 410
69120
Heidelberg
Germany |
Telephone:
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06221-5637153 |
Email:
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timo.brockmeyer@med.uni-heidelberg.de |
Affiliation:
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Klinik für Allgemeine Innere Medizin und Psychosomatik, Universitätsklinik Heidelberg |
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Name:
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Timo
Brockmeyer |
Address:
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Im Neuenheimer Feld 410
69120
Heidelberg
Germany |
Telephone:
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06221-5637153 |
Email:
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timo.brockmeyer@med.uni-heidelberg.de |
Affiliation:
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Klinik für Allgemeine Innere Medizin und Psychosomatik, Universitätsklinik Heidelberg |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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F50.2
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F50.9
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F50.2 F50.9
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Bulimia nervosa
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Eating disorder, unspecified
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Intervention(s)
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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.
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Primary Outcome(s)
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Number of subjective and objective binge eating attacks and global eating disorder psychopathology during the previous 2 months prior and after the intervention.
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Secondary Outcome(s)
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(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.
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Source(s) of Monetary Support
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Schweizer Anorexia Nervosa Stiftung
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Ethics review
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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
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