Hawai'i Postpartum Onset Depression Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Hawaii

About this trial

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:

1. When do depression and anxiety symptoms emerge, worsen, and improve across the first 6 months postpartum? 2. Can machine learning/artificial intelligence models prospectively predict clinically significant depression symptoms using Apple Watch metrics?

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Be at least 18 years old;

Be within two months after giving birth at the time of enrollment;

Live in Hawai'i;

Have access to an iPhone that is compatible with the study-specific iOS application and Apple Watch;

Disqualifiers

Less than 18 years old;

Has not given birth within the past 2 months;

Does not live in Hawai'i;

Does not have access to a study-compatible iPhone;

Trial population

We will recruit postpartum women across the Hawaiian Islands who have given birth within the last 2 months.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

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University of Hawaii

Lead sponsor

Apple Inc.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: