Approach Bias Modification as an Add-On to Smoking Cessation Treatment: A Randomized Controlled Trial

OBJECTIVE: Smoking is associated with an approach bias toward smoking-related stimuli. Approach bias modification (ApBM), a computerized training specifically designed to modify this approach bias, has shown positive effects in patients with alcohol use disorder; however, its efficacy as an add-on in smoking cessation treatment is inconclusive. The aim of this clinical trial was to investigate whether ApBM as an add-on to smoking cessation treatment results in higher 6-month prolonged abstinence rates compared to two control conditions. METHODS: In this randomized, controlled, double-blind, single-center superiority trial, 351 participants received a 1-day cognitive-behavioral smoking cessation treatment (treatment as usual [TAU]) and were subsequently randomized to either TAU+ApBM (N=119), TAU+sham training (N=115), or TAU only (N=117). Training sessions were conducted over 7 days. The primary outcome was prolonged abstinence at 6-month follow-up. Participants were classified as either nonsmoking (continuous abstinence for 6 months, ≤5 cigarettes since quit attempt, and breath CO level ≤9 ppm) or relapsed (no objective verification of smoking status, breath CO level ≥10 ppm, >5 cigarettes since quit attempt). RESULTS: In the intention-to-treat analyses, abstinence rates at 6 months were 19.3% (95% CI=12.13, 26.53) for TAU+ApBM, 17.4% (95% CI=10.36, 24.42) for TAU+sham training, and 16.2% (95% CI=9.46, 23.02) for TAU only, with no significant differences between groups. CONCLUSIONS: This large-scale clinical trial demonstrates that TAU+ApBM is not significantly superior to TAU+sham training or TAU only. ApBM has been included in Australian and German alcohol use disorder treatment guidelines, but this randomized controlled trial shows that positive effects do not apply to tobacco use disorder.