Postpartum Depression (PPD)NCT07866053
AI-Enabled Wearable Monitoring for Detection of Postpartum Depression and Anxiety
An observational study of Postpartum Depression (PPD) and Postpartum Anxiety, run by University of Hawaii at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression (PPD), Postpartum Anxiety
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will recruit postpartum women across the Hawaiian Islands who have given birth within the last 2 months.
Who may be able to join
- 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;
- Be able to understand the study information and provide informed consent; and
- Be able to read and complete study procedures in English.
Who cannot join
- 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;
- Cannot understand study information and provide informed consent; or
- Cannot read or complete study procedures in English.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Hawai'i at Mānoa
Honolulu, Hawaii, 96822
Zoë Barron, (805) 242-8408, reeflab@hawaii.edu
Yifan Wang, PhD
About this study
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:
- When do depression and anxiety symptoms emerge, worsen, and improve across the first 6 months postpartum?
- 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.
Read the detailed description
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.
- Conditions
- Postpartum Depression (PPD), Postpartum Anxiety
- Keywords
- postpartum depression, postpartum anxiety, wearables, Apple Watch, artificial intelligence, machine learning
- Medical subject headings
- Depression, Postpartum
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: Anytime between baseline and 6 months postpartum
Secondary outcomes (2)
Clinically Significant Change in EPDS Scores
Change of >= 4 between EPDS scores will indicate a clinically significant change (Matthey, 2004, Journal of Affective Disorders)
Measured: 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)
Measured: Anytime between baseline and 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postpartum Depression (PPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- Apple Inc.
- Responsible party
- Principal investigator, Yifan Wang, University of Hawaii
- Investigators
- Yifan Wang, PhD, Principal investigator, University of Hawai'i at Mānoa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866053
- Sponsor's protocol ID
- 2026-00652
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in results publication(s)
Publications
Simpson W, Glazer M, Michalski N, Steiner M, Frey BN. Comparative efficacy of the generalized anxiety disorder 7-item scale and the Edinburgh Postnatal Depression Scale as screening tools for generalized anxiety disorder in pregnancy and the postpartum period. Can J Psychiatry. 2014 Aug;59(8):434-40. doi: 10.1177/070674371405900806.
PubMed 25161068Levis B, Negeri Z, Sun Y, Benedetti A, Thombs BD; DEPRESsion Screening Data (DEPRESSD) EPDS Group. Accuracy of the Edinburgh Postnatal Depression Scale (EPDS) for screening to detect major depression among pregnant and postpartum women: systematic review and meta-analysis of individual participant data. BMJ. 2020 Nov 11;371:m4022. doi: 10.1136/bmj.m4022.
PubMed 33177069Solomonov N, Kerchner D, Dai Y, Kwon M, Callaghan DG, Schier MM, Zhang Y, Osborne LM, Benda NC. Prevalence and Trajectories of Perinatal Anxiety and Depression in a Large Urban Medical Center. JAMA Netw Open. 2025 Sep 2;8(9):e2533111. doi: 10.1001/jamanetworkopen.2025.33111.
PubMed 40982279Stefana A, Mirabella F, Gigantesco A, Camoni L; Perinatal Mental Health Network group. Factor structure, measurement invariance, and clinical change benchmarks of the Generalized Anxiety Disorder-7 (GAD-7) in pregnancy and postpartum. J Anxiety Disord. 2026 Mar;118:103123. doi: 10.1016/j.janxdis.2026.103123. Epub 2026 Jan 13.
PubMed 41547078Matthey S. Calculating clinically significant change in postnatal depression studies using the Edinburgh Postnatal Depression Scale. J Affect Disord. 2004 Mar;78(3):269-72. doi: 10.1016/S0165-0327(02)00313-0.
PubMed 15013253
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Enabled Wearable Monitoring for Detection of Postpartum Depression and Anxiety
- ClinicalTrials.gov ID
- NCT07866053
- Acronym / sponsor ID
- 2026-00652
- Conditions
- Postpartum Depression (PPD), Postpartum Anxiety
- Keywords
- postpartum depression, postpartum anxiety, wearables, Apple Watch, artificial intelligence, machine learning
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- Apple Inc.
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- When do depression and anxiety symptoms emerge, worsen, and improve across the first 6 months postpartum?
- 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit postpartum women across the Hawaiian Islands who have given birth within the last 2 months.
Key inclusion criteria (6 listed)
- 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;
- Be able to understand the study information and provide informed consent; and
Key exclusion criteria (6 listed)
- 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;
- Cannot understand study information and provide informed consent; or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinically Significant Depression Score Assessed by EPDS
Time frame: Anytime between baseline and 6 months postpartum
An Edinburgh Postnatal Depression Scale (EPDS) score >= 11 will indicate a clinically significant depression score (Levis et al., 2020, BMJ).
Alternate Metric for Clinically Significant Depression Score Assessed by EPDS
Time frame: Anytime between baseline and 6 months postpartum
An Edinburgh Postnatal Depression Scale (EPDS) score >= 13 will be an alternative metric for clinically severe depression score (Levis et al., 2020, BMJ).
Clinically Significant Anxiety Score Assessed by GAD-7
Time frame: Anytime between baseline and 6 months postpartum
GAD-7 Score >= 10 (Solomonov et al., 2025, JAMA Network Open)
Alternate Metric for Clinically Significant Anxiety Score Assessed by GAD-7
Time frame: Anytime between baseline and 6 months postpartum
GAD-7 score >= 13 will be an alternate threshold for determining clinically significant anxiety symptoms (Simpson et al., 2014, Canadian Journal of Psychiatry)
2 secondary outcomes
Clinically Significant Change in EPDS Scores
Time frame: Anytime between baseline and 6 months postpartum
Clinically Significant Change in GAD-7 Scores
Time frame: Anytime between baseline and 6 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 25161068Simpson W, Glazer M, Michalski N, Steiner M, Frey BN. Comparative efficacy of the generalized anxiety disorder 7-item scale and the Edinburgh Postnatal Depression Scale as screening tools for generalized anxiety disorder in pregnancy and the postpartum period. Can J Psychiatry. 2014 Aug;59(8):434-40. doi: 10.1177/070674371405900806.
- Background: PubMed 33177069Levis B, Negeri Z, Sun Y, Benedetti A, Thombs BD; DEPRESsion Screening Data (DEPRESSD) EPDS Group. Accuracy of the Edinburgh Postnatal Depression Scale (EPDS) for screening to detect major depression among pregnant and postpartum women: systematic review and meta-analysis of individual participant data. BMJ. 2020 Nov 11;371:m4022. doi: 10.1136/bmj.m4022.
- Background: PubMed 40982279Solomonov N, Kerchner D, Dai Y, Kwon M, Callaghan DG, Schier MM, Zhang Y, Osborne LM, Benda NC. Prevalence and Trajectories of Perinatal Anxiety and Depression in a Large Urban Medical Center. JAMA Netw Open. 2025 Sep 2;8(9):e2533111. doi: 10.1001/jamanetworkopen.2025.33111.
- Background: PubMed 41547078Stefana A, Mirabella F, Gigantesco A, Camoni L; Perinatal Mental Health Network group. Factor structure, measurement invariance, and clinical change benchmarks of the Generalized Anxiety Disorder-7 (GAD-7) in pregnancy and postpartum. J Anxiety Disord. 2026 Mar;118:103123. doi: 10.1016/j.janxdis.2026.103123. Epub 2026 Jan 13.
- Background: PubMed 15013253Matthey S. Calculating clinically significant change in postnatal depression studies using the Edinburgh Postnatal Depression Scale. J Affect Disord. 2004 Mar;78(3):269-72. doi: 10.1016/S0165-0327(02)00313-0.
- Individual participant dataSharing planned: Yes. IPD used in results publication(s)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yifan Wang, PhD principal investigator
University of Hawai'i at Mānoa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression (PPD) and Postpartum Anxiety, run by University of Hawaii at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoë Barron ((805) 242-8408, reeflab@hawaii.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically Significant Depression Score Assessed by EPDS (time frame: Anytime between baseline and 6 months postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07866053, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.