Trials (Mar 2022)
Efficacy of approach bias modification as an add-on to smoking cessation treatment: study protocol for a randomized-controlled double-blind trial
Abstract
Abstract Background Although effective treatments for smoking cessation are available, long-term abstinence is the exception rather than the norm. Accordingly, there is a need for novel interventions that potentially improve clinical outcome. Although implicit information processing biases, for example approach biases for smoking-related stimuli, are ascribed a dominant role in the maintenance of tobacco dependence, these biases are hardly targeted in current treatment. Past research has shown that so-called Approach Bias Modification (AppBM) trainings, aiming to modify this bias, lead to improved long-term abstinence in abstinent alcoholic inpatients when delivered as an add-on to treatment-as-usual. Findings on the efficacy of AppBM in smoking have been inconsistent. The present large-scale clinical trial pursues two goals. First, it aims to investigate the efficacy of AppBM as an add-on to treatment-as-usual in a representative sample of adult smokers. Second, possible mechanisms of change are investigated. Methods The study is a randomized-controlled, double-blind, parallel-group superiority trial. We aim at a final sample of at least 336 adult smokers. Participants are allocated with a 1:1:1 allocation ratio to one of the following conditions: (1) treatment-as-usual + AppBM, (2) treatment-as-usual + Sham, (3) treatment-as-usual only. During the add-on training, participants are presented smoking-related and positive pictures and are instructed to respond by either pushing or pulling a joystick, depending on the tilt of the pictures (5○ to the left/right). During AppBM, all smoking-related pictures are tilted in the direction that is associated with pushing, thereby aiming to train an avoidance bias for smoking. All positive pictures are tilted in the direction associated with pulling. During Sham, the contingency is 50/50. Participants are assessed before and after the intervention and at a 6-month follow-up. The primary outcome is prolonged abstinence, and secondary outcomes include smoking-related variables and psychological distress. Additionally, the motivational significance of smoking-related stimuli (i.e., approach bias, valence) is assessed with different experimental tasks (Approach-Avoidance Task; Single Target Implicit Association Test) and psychophysiological measures. Discussion This is the first large-scale clinical trial investigating the efficacy of AppBM as an add-on in smokers including a TAU only condition. Additionally, it is the first study to systematically investigate potential mechanisms mediating the effects of treatment on clinical outcome. Trial registration German Clinical Trials Register, DRKS00019221 , 11/11/2019
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