
Background: Bipolar Disorder (BD) affects 1-3% of the global population, characterized by extreme mood fluctuations including mania, hypomania, and depression. Traditional treatments such as pharmacotherapy and psychotherapy, while effective, are often limited by significant side effects, accessibility issues, and adherence challenges.Objective: This preliminary observational study evaluates the effectiveness and safety of Deep Brain Sound Stimulation (DBSS), a novel non-invasive auditory-based therapy, using user-reported outcomes from individuals with BD.Methods: Feedback was analyzed from 135 users who completed DBSS therapy for BD via the Vital Tones mobile application on the Apple App Store. Additionally, 9 participants provided detailed responses through in-app surveys assessing symptom improvements in mood regulation, emotional stability, and cognitive function. Descriptive statistics were employed to determine median effectiveness and satisfaction rates.Results: The therapy demonstrated a high user satisfaction rate of 97.78%, accompanied by a minimal refund rate of 2.22%. Survey respondents reported a median symptom improvement of 65% (95% CI: 51.85%–78.15%). DBSS was well-tolerated, with no severe adverse events reported and only rare instances of mild side effects such as transient dizziness and headaches. High adherence rates were observed, likely attributable to the therapy’s non-invasive, self-administered nature and user-friendly design.Conclusion: Preliminary findings suggest that DBSS is a promising non-invasive treatment for BD, offering significant symptom improvement and high user satisfaction. The strong safety profile and high adherence rates further support its potential as an accessible and effective therapeutic option. However, the observational nature of the study, small survey sample, and reliance on self-reported data indicate that further controlled research is necessary to validate these results and establish DBSS’s efficacy and safety for broader BD management
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