This 4-year study aims to develop a safe and effective management model for late-life depression using wearable technologies. The research will recruit older adults (aged 60 and above) with major depressive disorder, confirmed by DSM-5 criteria. In the first phase, participants will wear a research-grade actigraphy device (Geneactiv) for at least four weeks to assess its usability and accuracy compared with traditional questionnaires. In later phases, a double-blind randomized clinical trial will evaluate the efficacy of a photobiomodulation (PBM) headband in improving depressive and sleep symptoms. The project will also establish Taiwan's first longitudinal database integrating wearable data, clinical symptoms, and biological markers, aiming to identify digital phenotypes and predictive biomarkers for elderly depression. The study is expected to advance precision psychiatry and digital health applications in geriatric mental health care.
By 2025, Taiwan will become a super-aged society, with a rapidly growing number of older adults living with depression and related sleep problems. Late-life depression is often underdiagnosed and undertreated, and current assessments rely heavily on self-reported or clinician-rated questionnaires, which only provide snapshots of symptoms and may not accurately reflect daily variations in mood and sleep. These challenges highlight the urgent need for more objective, continuous, and accessible tools to monitor and manage depression in older adults. Wearable devices, such as actigraphy and photobiomodulation (PBM), offer new opportunities for both assessment and intervention. Actigraphy can provide objective data on sleep-wake cycles, activity levels, and circadian rhythms, while PBM uses near-infrared light to modulate brain activity and improve mood and sleep quality. Building on our previous collaboration with Harvard University and recent findings from wearable PBM trials, this project seeks to establish an integrated, technology-assisted model for managing late-life depression in Taiwan. This four-year project will begin by validating the feasibility and acceptability of a research-grade actigraphy device (Geneactiv) among older adults diagnosed with major depressive disorder (MDD). Objective activity and sleep data will be compared with questionnaire-based assessments to evaluate reliability and consistency, forming the foundation for Taiwan's first longitudinal wearable-based geriatric depression database. In the second and third years, the study will conduct a double-blind, randomized, sham-controlled clinical trial to evaluate the safety and effectiveness of a wearable PBM headband device in improving depressive symptoms and sleep quality. Participants will continue their regular treatments while using the PBM device at home for daily sessions. In the final year, longitudinal data from actigraphy, PBM intervention, clinical evaluations, and biological markers will be analyzed to identify digital phenotypes and predictive biomarkers associated with depression severity, treatment response, and functional outcomes. The long-term goal is to establish a comprehensive digital mental health platform that integrates biological, behavioral, and clinical dimensions, providing a scalable model for improving geriatric mental health in Taiwan's aging population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
162
A near-infrared photobiomodulation wearable device.
Participants allocated to this arm will receive neglectable photobiomodulation for up to 8 weeks, using a sham wearable headband.
China Medical University Beigang Hospital
London, Alabama, United Kingdom
Sleep and Circadian Rhythm
Sleep and circadian rhythm will be assessed using both questionnaire-based and device-based approaches. The questionnaire-based component will employ the Pittsburgh Sleep Quality Index (PSQI), which provides a total score ranging from 0 to 21, with lower scores indicating better sleep quality. The device-based component will analyze data from Geneactiv, processed with the validated open-source GGIR algorithm. 1. Five sleep variables will be derived: sleep onset time, wake-up time, total sleep duration, sleep efficiency, and wake after sleep onset (WASO). 2. Seven circadian rhythm variables will also be analyzed: light exposure amount and timing, M5/L5 (five-hour periods of highest/lowest activity), mean sleep midpoint time (MSA), intra-daily variability (IV), inter-daily stability (IS), daytime napping, and the Sleep Regularity Index (SRI).
Time frame: 8 weeks post-treatment.
Depression
Depression severity will be assessed using both questionnaire-based and device-based approaches. The questionnaire-based component will employ the depression severity assessed using the Hamilton Depression Rating Scale (HAM-D, 17-item version) which provides a total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. The device-based behavioral correlates (e.g., daytime activity, sleep fragmentation, light exposure regularity) derived from Geneactiv actigraphy will be analyzed to explore relationships with depressive symptom changes. Qualitative interviews will supplement quantitative findings to explore patient-reported mood changes and subjective well-being during the trial.
Time frame: 8 weeks post-treatment.
Feasibility, Acceptability, and User Experience of Device-Based Measurement and Management
Feasibility, satisfaction, and user experience with Geneactiv actigraphy and near-infrared photobiomodulation devices will be evaluated using: Quantitative assessments - Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST, Taiwanese version), compliance rate (measured by device-wearing duration and adherence), and completion rate of scheduled assessments. Qualitative interviews - conducted post-intervention to capture participants' experiences, perceived usability, and barriers to adoption. Data will be analyzed thematically to identify key factors affecting acceptability and implementation.
Time frame: From enrollment to the end of trial at 12 weeks
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