An observational study in Postpartum Depression (PPD) and Postpartum Anxiety, sponsored by University of Hawaii. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by University of Hawaii · Observational
The goal of this observational study is to examine whether passively collected wearable data can be used to predict onset and severity of postpartum depression and anxiety symptoms. The main questions it aims to answer are:
Women who have given birth within the past 2 months and who live in Hawai'i will be eligible for the study. Participants will wear an Apple Watch and answer weekly online survey questions until they reach 6 months postpartum. The study is designed to be fully remote to maximize accessibility across the Hawaiian Islands.
Mental health conditions are the leading cause of perinatal death in the United States, accounting for more than one-quarter of pregnancy-related deaths. Perinatal depression is particularly common, with up to 28% of postpartum individuals meeting criteria for clinically significant depression.
Objective, noninvasive biomarkers, particularly from wearables (e.g., Apple Watch), can passively measure sleep, activity, heart rate, and oxygen saturation, avoiding reporting bias and revealing underlying physiology. However, empirical evidence for wearable-based detection of postpartum depression is lacking, and it remains unclear whether individual variation in changing normative health metrics can be used to remotely monitor common mental health concerns, such as postpartum depression.
To address these gaps, the project proposes a fully remote study in Hawai'i, where geographic and access barriers are high. This project will enroll 100 women within 2 months postpartum and following them to 6 months, and collect Apple Watch metrics and weekly depression/anxiety symptom ratings. Practical AI/machine learning approaches will be designed to automatically process and analyze the large-scale wearable data, enabling the efficient integration of complex, time-varying signals, effective detection of subtle deviations, and accurate prediction of depressive episodes.
By integrating wearable-derived biometrics, weekly symptom tracking, and AI/ML prediction models, this study aims to identify digital biomarkers of postpartum depression and anxiety. These findings may support earlier screening, personalized monitoring, and timely referral for perinatal mental health care in Hawai'i and beyond, especially helping people living in rural areas and on neighbor islands, given that Hawai'i is classified as a state with low access to mental healthcare.
528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 88 observational studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →University of Hawaii is the lead sponsor of 96 studies on the registry; 21 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
We will recruit postpartum women across the Hawaiian Islands who have given birth within the last 2 months.
Exclusion Criteria:
Clinically Significant Depression Score Assessed by EPDS
An Edinburgh Postnatal Depression Scale (EPDS) score \>= 11 will indicate a clinically significant depression score (Levis et al., 2020, BMJ).
Time frame: Anytime between baseline and 6 months postpartum
Alternate Metric for Clinically Significant Depression Score Assessed by EPDS
An Edinburgh Postnatal Depression Scale (EPDS) score \>= 13 will be an alternative metric for clinically severe depression score (Levis et al., 2020, BMJ).
Time frame: Anytime between baseline and 6 months postpartum
Clinically Significant Anxiety Score Assessed by GAD-7
GAD-7 Score \>= 10 (Solomonov et al., 2025, JAMA Network Open)
Time frame: Anytime between baseline and 6 months postpartum
Alternate Metric for Clinically Significant Anxiety Score Assessed by GAD-7
GAD-7 score \>= 13 will be an alternate threshold for determining clinically significant anxiety symptoms (Simpson et al., 2014, Canadian Journal of Psychiatry)
Time frame: Anytime between baseline and 6 months postpartum
Clinically Significant Change in EPDS Scores
Change of \>= 4 between EPDS scores will indicate a clinically significant change (Matthey, 2004, Journal of Affective Disorders)
Time frame: Anytime between baseline and 6 months postpartum
Clinically Significant Change in GAD-7 Scores
Change of greater than 3 on the GAD-7 (Stefana et al., 2026, Anxiety Disorders)
Time frame: Anytime between baseline and 6 months postpartum
Plan to share: Yes — IPD used in results publication(s)
Supporting information: Study protocol, Sap, Analytic code
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University of Hawaii