BACKGROUND
Alcohol consumption is a leading cause of death and disability worldwide, associated with numerous acute and chronic medical conditions. Digital health interventions offer a promising solution to overcome barriers associated with traditional treatment methods, providing accessible, scalable, and cost-effective means to support individuals in reducing hazardous drinking.
OBJECTIVE
This pilot study aims to evaluate the feasibility, acceptability, and preliminary efficacy of the "Sober" smartphone app in individuals with hazardous alcohol use.
METHODS
This single-group, pre-post pilot study included 20 participants with hazardous alcohol use, identified using the Alcohol Use Disorder Identification Test (AUDIT). Participants used the "Sober" app for four weeks, which incorporates cognitive behavioral therapy(CBT)-based interventions. Feasibility was assessed by study and session completion rates, acceptability by participant satisfaction and perceived usefulness, and preliminary efficacy by changes in alcohol consumption and psychiatric symptoms.
RESULTS
Of the 20 enrolled participants, 17 completed the study. The app demonstrated high feasibility with an 85% study completion rate, and 58.8% completed all CBT sessions. Participants reported positive acceptability, with average satisfaction and usefulness ratings of 3.8 and 3.7 out of 5, respectively. Preliminary efficacy outcomes showed significant improvements: abstinence days increased from 66.8% to 84.8% (Z=-3.165, P=.002), heavy drinking episodes decreased from 3.3 to 1.9 (t=-2.965, P=.003), and total alcohol consumption reduced from 456.8 mL to 195.9 mL (t=3.159, P=.002). AUDIT scores dropped from 17.5 to 10.7 (t=4.513, P<.001). Additionally, depression (PHQ-9) scores decreased from 5.8 to 4.4 (t=2.908, P=.010), and anxiety (GAD-7) scores from 3.4 to 2.1 (Z=-2.801, P=.005). No adverse events were reported.
CONCLUSIONS
The mobile application "Sober" shows promise as an effective tool for reducing hazardous alcohol consumption and improving related psychiatric symptoms. The study demonstrated high feasibility and positive acceptability, with significant preliminary efficacy in reducing alcohol use. Feedback from participants and clinicians highlighted areas for improvement, which will be used to refine the app and study design for future research. Further research through a randomized controlled trial is warranted to confirm these findings and optimize the application’s features and content.
CLINICALTRIAL
The trial was registered on ClinicalTrials.gov (NCT06502756)