The VOICE-DEP study protocol: Multimodal analysis of voice and speech during medical interviews to support diagnosis and longitudinal monitoring of major depressive disorder
Abstract
Background: Major depressive disorder is a severe, recurrent and disabling condition. Although diagnosis and clinical monitoring are based on medical interviews and validated rating scales, voice and speech analysis may provide complementary digital biomarkers reflecting depressive severity and clinical evolution. However, current evidence remains limited by methodological heterogeneity, predominantly cross-sectional designs, limited longitudinal data and underrepresentation of non-English-speaking clinical populations.
Objective: The aim of the VOICE-DEP study is to develop and formalize a standardized, reproducible and clinically grounded protocol for the multimodal analysis of voice and speech during medical interviews as a tool to support the diagnosis of depressive disorder and to assess whether speech-derived digital biomarkers change over time in parallel with clinical severity measures.
Methods: VOICE-DEP is an observational, prospective, longitudinal pilot study of patients with major depressive disorder with a healthy control group, conducted in a hospital-based clinical setting in Spain. The study will include 25 adult patients with moderate or severe unipolar depression, with or without psychotic symptoms, and 50 healthy controls without a personal history of psychiatric disorders. Patients will be assessed at five time points: baseline (V0) and four monthly follow-up visits at 30, 60, 90 and 120 days. Healthy controls will be assessed once at baseline. The…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 125 participants or records.
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