Currently submitted to: JMIR Research Protocols
Date Submitted: Dec 13, 2025
Open Peer Review Period: Dec 16, 2025 - Feb 10, 2026
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Wearable-Based Assessment for Relapse Prediction Following Repetitive Transcranial Magnetic Stimulation for Depression: Protocol for a Feasibility Study (WARN-D Study)
ABSTRACT
Background:
A significant proportion of patients with major depressive disorder do not achieve remission after two antidepressant trials and are considered to suffer from Treatment-Resistant Depression (TRD). Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for TRD. However, relapse rates among remitters within the first year post-treatment are significant, and there are no validated markers of relapse. Wearable devices have shown positive results for longitudinal monitoring of health metrics and may be a promising tool for an early detection of relapse following rTMS treatment.
Objective:
To evaluate the feasibility of a wearable device (Oura ring) to monitor individuals receiving rTMS treatment for depression and its utility to detect early signs of depressive relapse in a 6-month follow-up period.
Methods:
This single-arm pilot study will recruit 20 outpatients with a major depressive episode receiving rTMS at St. Joseph’s Healthcare Hamilton, Ontario, Canada. Participants will be required to wear an Oura ring throughout the treatment course and during the six-month follow up. Clinical assessments, including Montgomery-Åsberg Depression Rating Scale (MADRS), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Insomnia Severity Index (ISI), and World Health Organization-Five Well-Being Index (WHO-5), will be collected at baseline, treatment end, and 3- and 6-month follow-ups, alongside bi-weekly PHQ-9 and GAD-7 scores. The primary outcomes are feasibility metrics (i.e., recruitment, adherence, retention, missing data, usability). Secondary outcomes will include the utility of wearable-based data for predicting relapse.
Results:
The study was funded in December 2025, and data collection will start following Ethics Approval.
Conclusions:
This study will provide initial evidence on the feasibility and utility of a wearable-based digital phenotyping in individuals receiving rTMS for TRD. Our findings will inform the design of future large-scale studies aimed at wearable-supported relapse prevention and precision monitoring in depression care.
Citation
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