Maintenance Notice

Due to necessary scheduled maintenance, the JMIR Publications website will be unavailable from Wednesday, July 01, 2020 at 8:00 PM to 10:00 PM EST. We apologize in advance for any inconvenience this may cause you.

Who will be affected?

Accepted for/Published in: Journal of Medical Internet Research

Date Submitted: Apr 23, 2025
Date Accepted: Feb 13, 2026
Date Submitted to PubMed: Feb 23, 2026

The final, peer-reviewed published version of this preprint can be found here:

The Role of Digital Biomarkers in Physiological Signal-Based Depression Assessment: Systematic Review and Meta-Analysis

Lee H, Kang SG, Lee SH

The Role of Digital Biomarkers in Physiological Signal-Based Depression Assessment: Systematic Review and Meta-Analysis

J Med Internet Res 2026;28:e76432

DOI: 10.2196/76432

PMID: 41926632

The Role of Digital Biomarkers in Physiological Signal-Based Depression Assessment: A Systematic Review and Meta-Analyses

  • Hyeongsuk Lee; 
  • Seung-Gul Kang; 
  • Seon Heui Lee

ABSTRACT

Background:

Digital biomarkers are increasingly used to diagnose depression. Most existing research has focused on individual digital biomarkers (e.g., HRV or sleep data), whereas there are few integrative assessments or comprehensive explorations of the multidimensional aspects of depression.

Objective:

We systematically reviewed the role of digital biomarkers in depression assessment and management. Digital biomarkers, including physiological and behavioral indicators collected through wearable devices, smartphones, and sensors, offer objective, continuous, and real-time data; minimize recall bias; and provide insights into the multifaceted nature of depression.

Methods:

A comprehensive search of multiple international and Korean databases, including the Cochrane Library, OVID-MEDLINE, PsycINFO, CINAHL, IEEE Xplore, Web of Science, KISS, RISS, KMbase, and KoreaMed, was conducted without language restrictions. The search terms included variations of “depression,” “MDD,” “wearable,” “smartwatch,” “biomarker,” “sleep,” “speech,” “behavioral parameter,” “electroencephalogram,” and “electrocardiogram.” We identified 121 studies meeting the inclusion criteria, encompassing diverse biomarker categories, such as sleep, physical activity, cardiac parameters, speech, global positioning system data, and circadian rhythms.

Results:

The key findings revealed significant associations between depression and parameters. Meta-analyses showed that individuals with depression had significantly lower sleep efficiency (–3.10%, 95% confidence interval [CI]: –5.81 to –0.40, p = 0.02), longer sleep onset latency (+4.72 min, 95% CI: 2.46 to 7.04, p < 0.01), longer time in bed (+31.43 min, 95% CI: 24.19 to 38.68, p < 0.001), and more wake after sleep onset (+0.41 min, 95% CI: 0.01 to 0.80, p = 0.04). Among cardiac parameters, the nighttime mean heart rate was significantly higher in depressed individuals (+2.38 bpm, 95% CI: 0.16 to 4.60, p = 0.04). Moderate-to-vigorous physical activity was also significantly lower (–8.99 min, 95% CI: –10.84 to –7.13, p < 0.001). In contrast, other markers such as light physical activity and certain cardiac measures showed inconsistent results. Personalization emerged as a crucial factor, with specific biomarkers displaying stronger predictive power based on age, time, and individual variability. Furthermore, personalized multi-biomarker models may provide a more reliable means of tracking depression if they also feature temporal and longitudinal monitoring. Despite promising advancements, challenges, such as heterogeneity in methodologies and limited longitudinal research, suggest the need for standardized approaches and further exploration of qualitative metrics.

Conclusions:

This review highlights the potential of integrating multimodal digital biomarkers to enhance the precision of depression assessment and monitoring. By synthesizing evidence across diverse biomarker categories, this study identified several clinically meaningful indicators, providing a valuable foundation for future personalized and data-driven depression diagnostics. Clinical Trial: The protocol for this review was prospectively registered in the PROSPERO systematic review database (registry number: CRD42024518136).


 Citation

Please cite as:

Lee H, Kang SG, Lee SH

The Role of Digital Biomarkers in Physiological Signal-Based Depression Assessment: Systematic Review and Meta-Analysis

J Med Internet Res 2026;28:e76432

DOI: 10.2196/76432

PMID: 41926632

Download PDF


Request queued. Please wait while the file is being generated. It may take some time.

© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.