Modified cue exposure for adolescents with binge eating behaviour: study protocol of a randomised pilot trial called EXIT.

Introduction: Binge eating (BE) behaviour is highly prevalent in adolescents, and can result in serious metabolic derangements and overweight in the long term. Weakened functioning of the behavioural inhibition system is one potential pathway leading to BE. Food cue exposure focusing on expectancy violation (CE) is a short intervention for BE that has proven effective in adults but has never been tested in adolescents. Thus, the current randomised pilot trial evaluates the feasibility of CE for adolescents and its efficacy in reducing eating in the absence of hunger (EAH) of binge food items.

Methods And Analysis: The trial will include =76 female adolescents aged between 13 and 20 years with a diagnosis of bulimia nervosa, binge eating disorder (BED) or their subthreshold forms based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Participants will be randomly assigned to two sessions of CE or behavioural analysis (BA), a classical cognitive-behavioural therapy-based intervention. The primary endpoint is the change in EAH measured according to ad libitum consumption of personally preferred binge food in a bogus taste test at post-test based on the intention-to-treat population. Key secondary endpoints are changes in EAH of standardised binge food at post-test, in EAH at 3-month follow-up (FU) and in food craving after induction of food cue reactivity at post-test and FU. To identify further valid outcome parameters, we will assess effects of CE compared with BA on global ED psychopathology, BE frequency within the last 28 days, body weight, response inhibition and emotion regulation abilities. Treatment groups will be compared using analysis of covariance with intervention as fixed factor and body mass index at baseline as covariate.

Ethics And Dissemination: This clinical trial has been approved by the Ethics Review Committee of the Medical Association of Rhineland-Palatinate and the Medical Faculty of the Ruhr-University Bochum. The collected data will be disseminated locally and internationally through publications in relevant peer-reviewed journals and will be presented at scientific and clinical conferences. Participants data will only be published in an anonymised form.

Trial Registration Number: DRKS00024009.