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The ABBA study – approach bias modification in bulimia nervosa and binge eating disorder: study protocol for a randomised controlled trial

View Article: PubMed Central - PubMed

ABSTRACT

Background: The 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.

Methods: This 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.

Discussion: This 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 registration: DRKS00010231 (retrospectively registered on 24 March 2016; first version)

No MeSH data available.


Participant flow chart
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Fig1: Participant flow chart

Mentions: This is a superiority trial adopting a double-blind, randomised, placebo-controlled, parallel-group design comparing real and sham CBM. Participants with BN or BED will be randomly allocated to receive either 10 sessions (15 min each) of real CBM (treatment group) or sham CBM (control group) in a period of 4 weeks. Participants will be recruited from two different sites (Heidelberg, Germany and London, UK). Outcomes will be assessed at baseline, post-treatment and 2-month follow-up. The study protocol is outlined in the flow chart in Fig. 1, and Table 1 provides details of all assessments at the different timepoints.Fig. 1


The ABBA study – approach bias modification in bulimia nervosa and binge eating disorder: study protocol for a randomised controlled trial
Participant flow chart
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC5037622&req=5

Fig1: Participant flow chart
Mentions: This is a superiority trial adopting a double-blind, randomised, placebo-controlled, parallel-group design comparing real and sham CBM. Participants with BN or BED will be randomly allocated to receive either 10 sessions (15 min each) of real CBM (treatment group) or sham CBM (control group) in a period of 4 weeks. Participants will be recruited from two different sites (Heidelberg, Germany and London, UK). Outcomes will be assessed at baseline, post-treatment and 2-month follow-up. The study protocol is outlined in the flow chart in Fig. 1, and Table 1 provides details of all assessments at the different timepoints.Fig. 1

View Article: PubMed Central - PubMed

ABSTRACT

Background: The 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.

Methods: This 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.

Discussion: This 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 registration: DRKS00010231 (retrospectively registered on 24 March 2016; first version)

No MeSH data available.