Abstract
BackgroundThe core symptoms of bulimia nervosa (BN) and binge eating disorder (BED) are recurrent episodes of binge eating. Despite negative psychological and physical consequences, BN/BED patients show uncontrollable approach tendencies towards food. This cognitive bias occurs at an early stage of information processing. Cognitive bias modification (CBM) directly targets such biases and has been shown to be effective in treating several mental disorders. In alcohol addiction, automatic action tendencies towards alcohol cues and relapse rates were successfully reduced by a specific form of CBM, termed approach bias modification. Based on these findings and data from a proof-of-concept study in people with high levels of food craving, CBM is considered a promising new treatment approach for BN/BED. Given the similarities between BN/BED and addictive disorders, the rationale for using approach bias modification appears to be particularly strong. The aim of the present study is to examine whether, compared to a sham training, computerised approach bias modification (10 sessions) can reduce binge-eating episodes in BN/BED patients from pre-treatment to follow-up. Additionally, we will investigate whether this CBM programme also reduces global eating disorder psychopathology, trait and cue-elicited food craving, food intake as well as approach and attentional bias towards visual food cues. Treatment acceptance will be determined by attrition rates and responses on a feedback form.MethodsThis is a double-blind, randomised, placebo-controlled, parallel-group superiority trial with two parallel arms. A total of 54 BN/BED patients will be recruited. Approach bias towards food will be retrained by a computer task adopting an implicit learning paradigm. Patients in the control condition (sham) will conduct a similar task but will not be trained to avoid food cues. Methods against bias include public registration, randomisation by a central study office, standardisation of the treatments and blinding of assessors. Furthermore, the session number and duration will be equivalent in the two conditions.DiscussionThis is the first registered randomised controlled trial of approach bias modification in a clinical BN/BED sample. Results from this study will provide an indication of the efficacy of approach bias modification training for BN/BED and the potential mechanisms of action underlying this treatment.Trial registrationDRKS00010231 (retrospectively registered on 24 March 2016; first version)
Highlights
MethodsThis is a double-blind, randomised, placebo-controlled, parallel-group superiority trial with two parallel arms
The core symptoms of bulimia nervosa (BN) and binge eating disorder (BED) are recurrent episodes of binge eating
Supporting this assumption, bulimic eating disorders such as BN and BED are associated with strong, impulsive responses and poor cognitive control towards food cues, which is considered to contribute to a heightened susceptibility to sensitised cues that trigger action tendencies and lead to binge eating [12]
Summary
Design This is a superiority trial adopting a double-blind, randomised, placebo-controlled, parallel-group design comparing real and sham CBM. Sample size Previous randomised controlled trials comparing real and sham versions of approach bias modification in clinical samples applied a repeated measures ANOVA design (group × time) to examine treatment-specific changes and have reported small-to-medium effect sizes (ηp between 0.05 and 0.06) [27, 29, 30]. Intervention Patients in the real CBM condition will conduct a treatment version of the Food Approach-Avoidance Task (Food-AAT) [39] In this task, participants are shown colour photographs of food and control (i.e. neutral household and office) items on a computer screen. Patients in the control condition receive 10 additional sessions of the pre- and post-treatment assessment version of the task (Food-AAT), which requires an equal number of approach and avoidance movements to both food and non-food pictures. It is intended that the results of the study will be reported and disseminated by the principal investigators at international conferences and in peer-reviewed scientific journals
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