‘Re-Train Your Brain’: Protocol for a randomized controlled pilot trial of a web-based Cognitive Bias Modification intervention for emerging adults with comorbid social anxiety and hazardous alcohol use (Preprint)

Abstract

Alcohol use and anxiety disorders commonly co-occur, resulting in a more severe clinical presentation and poorer response to single-disorder treatments. Research has shown that Approach Bias Modification (ApBM) and Interpretation Bias Modification (IBM) cognitive re-training interventions can be efficacious adjunctive treatments that improve outcomes for alcohol use and social anxiety symptoms, respectively. However, the acceptability, feasibility and clinical utility of combining ApBM and IBM programs to optimise standard treatments among comorbid samples is unknown. It is also unclear as to whether integrating ApBM and IBM within each training session, or alternating them between each session, is more acceptable and efficacious.

This paper describes the study protocol for a randomized controlled pilot trial investigating the feasibility, acceptability, and preliminary efficacy of the ‘Re-Train Your Brain’ intervention – an adjunct web-based ApBM+IBM program – among a clinical sample of emerging adults with hazardous alcohol use and social anxiety.

The study involves a 3-arm randomized controlled pilot trial in which treatment-seeking emerging adults (18-30 years) with co-occurring hazardous alcohol use and social anxiety disorder symptoms will be individually randomized to receive: (1) the Re-Train Your Brain ‘integrated’ program, delivered with 10 bi-weekly sessions focusing on both social anxiety and alcohol each week (50:50 ratio), plus treatment as usual (TAU i.e., the model of care provided in accordance with standard practice at their service; n=30); (2) the Re-Train Your Brain ‘alternating’ program, delivered with 10 bi-weekly sessions focusing on social anxiety one week and alcohol the next week in an alternating pattern, plus TAU (n=30); or (3) TAU only (n=30). Primary outcomes include feasibility (uptake, follow-up rates, treatment adherence, attrition, adverse events) and acceptability (system usability, client satisfaction, user experience, training format preference). Secondary efficacy outcomes include changes in alcohol approach and interpretation biases, social anxiety symptoms, and alcohol use (e.g., average drinks per day, binge-drinking, alcohol use motives, severity of alcohol dependence, alcohol craving). The primary endpoint will be post-treatment (6 weeks post-baseline), with a secondary endpoint at 3 months post-baseline. Descriptive statistics will be conducted for primary outcomes, while intention-to-treat multi-level mixed effects analysis for repeated measures will be performed for secondary outcomes.

The study is funded from 2019―2023 by Australian Rotary Health. Recruitment is expected to be complete by mid―late 2022, with follow-ups completed by early 2023.

The study will be the first to evaluate whether an ApBM+IBM program is acceptable to treatment-seeking emerging adults and whether it is feasible to deliver it online, in settings where it will ultimately be used (e.g., at home). The findings will broaden our understanding of the types of programs that emerging adults will engage with, and whether there is preliminary evidence of it being an efficacious treatment option for this comorbidity.

Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620001273976