Background and Aims: Several randomised controlled trials (RCTs) have demonstrated that delivering approach bias modification (ApBM) during residential alcohol use disorder (AUD) treatment reduces likelihood of post-treatment relapse. However, few studies have examined ApBM′s efficacy for AUD in outpatient settings. We trialled a personalised ApBM smartphone app in individuals receiving outpatient treatment for AUD. Design: We conducted a double-blind RCT. Participants were randomised to receive treatment as usual (TAU) + ApBM or TAU + sham training over a 4-week intervention period. Setting: Participants were recruited from alcohol and other drug treatment services in Melbourne, Australia. Participants: 79 participants (mean age 46.6 years; 45 male, 34 female) installed the app between May 26, 2022 and January 23, 2024. Intervention and Comparator: In the ApBM condition, the app delivered personalised, gamified ApBM. Participants were prompted by notifications to complete at least 2 sessions of ApBM per week for 4 weeks. The Control version prompted participants to complete a weekly sham-training task for 4 weeks. Measurements: Participants self-reported past-week alcohol use via the app at baseline and 4, 8, and 16 weeks after installing the app. We used these data to derive number of standard drinks (defined as 10 grams pure alcohol) consumed (primary outcome), past-week drinking days, and past-week heavy drinking days (days when >5 standard drinks were consumed). Participants also completed questionnaire measures of AUD severity, quality of life, and alcohol craving. Findings: We found a significant time x group interaction for the primary outcome (coefficient: -1.11, 95% CI: [-2.08, 0-.13]; z(78) = -2.22; p=.03,). Past-week standard drinks declined significantly in ApBM participants (reducing by 55% between baseline and the final follow-up), but not controls (non-significant 11% reduction). Time x group interaction effects were non-significant for all secondary outcomes. Conclusions: Personalised smartphone ApBM may help reduce alcohol consumption in AUD outpatients.
Competing Interest StatementThe authors have declared no competing interest.
Clinical TrialNCT05120856
Funding StatementThis study was funded by Alcohol and Drug Research Innovation Agenda (ADRIA), The Victorian Alcohol and Drug Association (VAADA). ADRIA/VAADA played no role in study design or in collection, management, analysis, interpretation, or publication of data.
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The study was approved by the St Vincent′s Hospital Melbourne Human Research Ethics Committee (HREC)(268/21) and the Monash University HREC (project number: 31260)
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Data AvailabilityAll data produced in the present study are available upon reasonable request to the authors. Those requesting data will need to be responsible for any costs associated with data sharing agreements and/or ethical approval for sharing data.
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