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Open Access 01-12-2022 | Study protocol

Efficacy of approach bias modification as an add-on to smoking cessation treatment: study protocol for a randomized-controlled double-blind trial

Authors: Charlotte E. Wittekind, Keisuke Takano, Philipp Sckopke, Markus H. Winkler, Gabriela G. Werner, Thomas Ehring, Tobias Rüther

Published in: Trials | Issue 1/2022

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

Available only for authorised users

At the moment of planning the study, there was only one published study [32] in which a short CBT intervention was combined with AppBM vs. Sham training in a sample of adult smokers. As the study used number of daily cigarettes as the primary outcome, but not abstinence rates, the power calculation was based on the number of daily cigarettes.

An indirect instruction is used for the trainings for two reasons: First, if picture content is task-irrelevant, blinding is more likely to be maintained. Second, it is easier to realize the 50/50 contingency of the Sham training.

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Title: Efficacy of approach bias modification as an add-on to smoking cessation treatment: study protocol for a randomized-controlled double-blind trial
Authors: Charlotte E. Wittekind
Keisuke Takano
Philipp Sckopke
Markus H. Winkler
Gabriela G. Werner
Thomas Ehring
Tobias Rüther
Publication date: 01-12-2022
Publisher: BioMed Central
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06155-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Efficacy of approach bias modification as an add-on to smoking cessation treatment: study protocol for a randomized-controlled double-blind trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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