Postpartum DepressionCDSNCT06818734
Implementation of a Clinical Decision Support Tool for Postpartum Depression
A study testing Clinical Decision Support Tool in people with Postpartum Depression, run by Weill Medical College of Cornell University at 4 sites in United States.
Trial summary
This study will evaluate the use of an automated process in the electronic health record (EHR) that will help providers to detect patients at risk of developing postpartum depression (PPD). 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
- What is being tested?
- Clinical Decision Support Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2026to 1 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- 18 years or older
- being seen at one of participating clinics
- pregnancy at 20 week gestation or more
Who cannot join
- Does not speak inclusion
- does not have internet access
- Clinician eligibility:
- If they manage patients in the three clinics as a board-certified OBGYN clinician.
- No exclusion criteria apply for clinician based on their knowledge and experience in treating PPD
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Not yet recruiting
Center for Community Health: 515 6th street (3rd floor)
Brooklyn, New York, 11215
Tracy Grossman, MD, trg2005@med.cornell.edu
Jessica Miller, 718-499-2273
- Recruiting
Ob GYN Lower Manhattan 156 William street, New York City
New York, New York, 10038
Szilvia Nagy, MD, szn3001@med.cornell.edu
Szilvia Nagy, MD
- Recruiting
Weill Cornell Medicine OBGYN practice 72 street
New York, New York, 10065
Allison Boester, MD
- Recruiting
Weill Cornell Medicine- Women's Health practice 505 East 70th street, New York City
New York, New York, 10065
Rochelle Joly, MD, roj9069@med.cornell.edu
Rochelle Joly, MD
About this study
This study will evaluate the use of an automated process in the electronic health record (EHR) that will help providers to detect patients at risk of developing postpartum depression (PPD).
Read the detailed description
The goal of this randomized clinical trial is to assess the implementation of a clinical decision support (CDS) tool. The tool is designed to assist providers in managing patients at risk of developing of postpartum depression.
Investigators hypothesize that this tool will be acceptable and feasible for use and improve the use of mental health services for postpartum depression.
Patients in the control arm will receive usual care, while those in the intervention arm will receive CDS.
Clinicians will manage patients per usual care, including initiating PPD preventive such as conducting referrals to nutrition and behavioral health, suggest educational readings through patient portals, or no actions. Clinicians in the intervention arm will refer patients based on the CDS.
- Conditions
- Postpartum Depression
- Being tested
- Clinical Decision Support Tool
- Keywords
- Clinical decision support tool
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision Support ToolOther
The CDS in and AI algorithm that will alert clinicians only if patients have high risk of developing PPD, and provide clinicians with risk score, risk factors, and anticipatory actions with an order set to assist with ordering. Clinicians will make the ultimate clinical judgement after receiving CDS aid, including taking no actions towards PPD prevention. Clinicians will manage patients per usual care, including initiating PPD prevention such as conducting referrals to nutrition and behavioral health, suggest educational readings through patient portals, or no actions. Clinicians in the intervention arm will refer patients based on the CDS.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: CDS support , clinician | Experimental | Clinicians in the intervention arm will refer patients based on the CDS.The CDS will alert clinicians only if patients have high risk of developing PPD, and provide clinicians with risk score, risk factors, and anticipatory actions with an order set to assist with ordering. Clinicians will make the ultimate clinical judgement after receiving CDS aid, including taking no actions towards PPD prevention. Clinicians will manage patients per usual care, including initiating PPD preventive such as conducting referrals to nutrition and behavioral health, suggest educational readings through patient portals, or no actions. Receives: Other: Clinical Decision Support Tool |
| No intervention: Patients | No intervention | The CDS will alert clinicians only if patients have high risk of developing PPD. Clinicians will manage patients per usual care, including initiating PPD preventive such as conducting referrals to nutrition and behavioral health, suggest educational readings through patient portals, or no actions. |
| Intervention: Patients | Experimental | Not described Receives: Other: Clinical Decision Support Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability as measured by Unified Theory of Technology Acceptance Theory (UTAUT).
UTAUT has five constructs: performance expectation, effort expectation, social influence, facilitating conditions, and behavioral intention. The performance expectation construct in UTAUT is the CDS's ability to identify patients at risk of PPD that clinicians agree with. For each construct, responses will be sought in the 7-point Likert scale, setting 1 as 'strongly disagree', 2 as 'disagree', to 7 as 'strongly agree'. We will average the acceptability survey responses at the end of the study for each of the 5 UTAUT constructs to create a binary variable. An average score of 5 or above will be considered acceptance and non-acceptance otherwise
Measured: One month after initiation of tool use and three months after use.
Appropriateness as measured by Appropriateness Measure (IAM).
IAM is a 4-item measure to assess the appropriateness of the intervention, respectively, with excellent usability. IAM is to be answered by participants in 5-point response scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree.
Measured: One month after initiation of tool use and three months after use.
Feasibility as measured by Feasibility of Intervention Measure (FIM).
FIM is a 4-item measure to assess the feasibility of the intervention, respectively, with excellent usability. FIM is to be answered by participants in 5-point response scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree.
Measured: One month after initiation of tool use and three months after use.
Mental Health service utilization as measured by number of mental health visits
Mental health service utilization includes presentations to ED or inpatient admission for mental health related reasons.
Measured: one month and three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Jul 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yiye Zhang, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818734
- Sponsor's protocol ID
- 24-03027259
- Acronym
- CDS
- Status last verified
- Jul 2026
- First submitted
- 7 Feb 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol with the statistical analysis plan will be available following publication.
Publications
Krause N, Borawski-Clark E. Social class differences in social support among older adults. Gerontologist. 1995 Aug;35(4):498-508. doi: 10.1093/geront/35.4.498.
PubMed 7557520Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.
PubMed 11491192Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Zhang Y, Wang S, Hermann A, Joly R, Pathak J. Development and validation of a machine learning algorithm for predicting the risk of postpartum depression among pregnant women. J Affect Disord. 2021 Jan 15;279:1-8. doi: 10.1016/j.jad.2020.09.113. Epub 2020 Sep 30.
PubMed 33035748Wang S, Pathak J, Zhang Y. Using Electronic Health Records and Machine Learning to Predict Postpartum Depression. Stud Health Technol Inform. 2019 Aug 21;264:888-892. doi: 10.3233/SHTI190351.
PubMed 31438052Venkatesh KK, Nadel H, Blewett D, Freeman MP, Kaimal AJ, Riley LE. Implementation of universal screening for depression during pregnancy: feasibility and impact on obstetric care. Am J Obstet Gynecol. 2016 Oct;215(4):517.e1-8. doi: 10.1016/j.ajog.2016.05.024. Epub 2016 May 20.
PubMed 27210067Dunkel Schetter C, Tanner L. Anxiety, depression and stress in pregnancy: implications for mothers, children, research, and practice. Curr Opin Psychiatry. 2012 Mar;25(2):141-8. doi: 10.1097/YCO.0b013e3283503680.
PubMed 22262028Cox EQ, Sowa NA, Meltzer-Brody SE, Gaynes BN. The Perinatal Depression Treatment Cascade: Baby Steps Toward Improving Outcomes. J Clin Psychiatry. 2016 Sep;77(9):1189-1200. doi: 10.4088/JCP.15r10174.
PubMed 27780317Werner E, Miller M, Osborne LM, Kuzava S, Monk C. Preventing postpartum depression: review and recommendations. Arch Womens Ment Health. 2015 Feb;18(1):41-60. doi: 10.1007/s00737-014-0475-y. Epub 2014 Nov 25.
PubMed 25422150Curtin SC, Abma JC, Ventura SJ, Henshaw SK. Pregnancy rates for U.S. women continue to drop. NCHS Data Brief. 2013 Dec;(136):1-8.
PubMed 24314113Joly R, Gossey TJ, Daoud AK, Zhang Y. Implementation of a clinical decision support tool for postpartum depression: protocol for a prospective randomised clinical trial. BMJ Open. 2026 May 18;16(5):e114571. doi: 10.1136/bmjopen-2025-114571.
PubMed 42150830
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Clinical Decision Support Tool for Postpartum Depression
- ClinicalTrials.gov ID
- NCT06818734
- Acronym / sponsor ID
- CDS / 24-03027259
- Conditions
- Postpartum Depression
- Keywords
- Clinical decision support tool
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 10 Feb 2025 (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.
This study will evaluate the use of an automated process in the electronic health record (EHR) that will help providers to detect patients at risk of developing postpartum depression (PPD).
Detailed description
The goal of this randomized clinical trial is to assess the implementation of a clinical decision support (CDS) tool. The tool is designed to assist providers in managing patients at risk of developing of postpartum depression.
Investigators hypothesize that this tool will be acceptable and feasible for use and improve the use of mental health services for postpartum depression.
Patients in the control arm will receive usual care, while those in the intervention arm will receive CDS.
Clinicians will manage patients per usual care, including initiating PPD preventive such as conducting referrals to nutrition and behavioral health, suggest educational readings through patient portals, or no actions. Clinicians in the intervention arm will refer patients based on the CDS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention: CDS support , clinician | Experimental | Other: Clinical Decision Support ToolClinicians in the intervention arm will refer patients based on the CDS.The CDS will alert clinicians only if patients have high risk of developing PPD, and provide clinicians with risk score, risk factors, and anticipatory actions with an order set to assist with ordering. Clinicians will make the ultimate clinical judgement after receiving CDS aid, including taking no actions towards PPD prevention. Clinicians will manage patients per usual care, including initiating PPD preventive such as conducting referrals to nutrition and behavioral health, suggest educational readings through patient portals, or no actions. |
| No intervention: Patients | No intervention | –The CDS will alert clinicians only if patients have high risk of developing PPD. Clinicians will manage patients per usual care, including initiating PPD preventive such as conducting referrals to nutrition and behavioral health, suggest educational readings through patient portals, or no actions. |
| Intervention: Patients | Experimental | Other: Clinical Decision Support Tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- being seen at one of participating clinics
- pregnancy at 20 week gestation or more
Key exclusion criteria (5 listed)
- Does not speak inclusion
- does not have internet access
- If they manage patients in the three clinics as a board-certified OBGYN clinician.
- No exclusion criteria apply for clinician based on their knowledge and experience in treating PPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Decision Support ToolThe CDS in and AI algorithm that will alert clinicians only if patients have high risk of developing PPD, and provide clinicians with risk score, risk factors, and anticipatory actions with an order set to assist with ordering. Clinicians will make the ultimate clinical judgement after receiving CDS aid, including taking no actions towards PPD prevention. Clinicians will manage patients per usual care, including initiating PPD prevention such as conducting referrals to nutrition and behavioral health, suggest educational readings through patient portals, or no actions. Clinicians in the intervention arm will refer patients based on the CDS. | Other | Intervention: CDS support , clinician, Intervention: Patients |
Primary outcome
Acceptability as measured by Unified Theory of Technology Acceptance Theory (UTAUT).
Time frame: One month after initiation of tool use and three months after use.
UTAUT has five constructs: performance expectation, effort expectation, social influence, facilitating conditions, and behavioral intention. The performance expectation construct in UTAUT is the CDS's ability to identify patients at risk of PPD that clinicians agree with. For each construct, responses will be sought in the 7-point Likert scale, setting 1 as 'strongly disagree', 2 as 'disagree', to 7 as 'strongly agree'. We will average the acceptability survey responses at the end of the study for each of the 5 UTAUT constructs to create a binary variable. An average score of 5 or above will be considered acceptance and non-acceptance otherwise
Appropriateness as measured by Appropriateness Measure (IAM).
Time frame: One month after initiation of tool use and three months after use.
IAM is a 4-item measure to assess the appropriateness of the intervention, respectively, with excellent usability. IAM is to be answered by participants in 5-point response scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree.
Feasibility as measured by Feasibility of Intervention Measure (FIM).
Time frame: One month after initiation of tool use and three months after use.
FIM is a 4-item measure to assess the feasibility of the intervention, respectively, with excellent usability. FIM is to be answered by participants in 5-point response scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree.
Mental Health service utilization as measured by number of mental health visits
Time frame: one month and three month
Mental health service utilization includes presentations to ED or inpatient admission for mental health related reasons.
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 30 Jul 2026.
- Background: PubMed 7557520Krause N, Borawski-Clark E. Social class differences in social support among older adults. Gerontologist. 1995 Aug;35(4):498-508. doi: 10.1093/geront/35.4.498.
- Background: PubMed 11491192Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Background: PubMed 33035748Zhang Y, Wang S, Hermann A, Joly R, Pathak J. Development and validation of a machine learning algorithm for predicting the risk of postpartum depression among pregnant women. J Affect Disord. 2021 Jan 15;279:1-8. doi: 10.1016/j.jad.2020.09.113. Epub 2020 Sep 30.
- Background: PubMed 31438052Wang S, Pathak J, Zhang Y. Using Electronic Health Records and Machine Learning to Predict Postpartum Depression. Stud Health Technol Inform. 2019 Aug 21;264:888-892. doi: 10.3233/SHTI190351.
- Background: PubMed 27210067Venkatesh KK, Nadel H, Blewett D, Freeman MP, Kaimal AJ, Riley LE. Implementation of universal screening for depression during pregnancy: feasibility and impact on obstetric care. Am J Obstet Gynecol. 2016 Oct;215(4):517.e1-8. doi: 10.1016/j.ajog.2016.05.024. Epub 2016 May 20.
- Background: PubMed 22262028Dunkel Schetter C, Tanner L. Anxiety, depression and stress in pregnancy: implications for mothers, children, research, and practice. Curr Opin Psychiatry. 2012 Mar;25(2):141-8. doi: 10.1097/YCO.0b013e3283503680.
- Background: PubMed 27780317Cox EQ, Sowa NA, Meltzer-Brody SE, Gaynes BN. The Perinatal Depression Treatment Cascade: Baby Steps Toward Improving Outcomes. J Clin Psychiatry. 2016 Sep;77(9):1189-1200. doi: 10.4088/JCP.15r10174.
- Background: PubMed 25422150Werner E, Miller M, Osborne LM, Kuzava S, Monk C. Preventing postpartum depression: review and recommendations. Arch Womens Ment Health. 2015 Feb;18(1):41-60. doi: 10.1007/s00737-014-0475-y. Epub 2014 Nov 25.
- Background: PubMed 24314113Curtin SC, Abma JC, Ventura SJ, Henshaw SK. Pregnancy rates for U.S. women continue to drop. NCHS Data Brief. 2013 Dec;(136):1-8.
- Derived from this study: PubMed 42150830Joly R, Gossey TJ, Daoud AK, Zhang Y. Implementation of a clinical decision support tool for postpartum depression: protocol for a prospective randomised clinical trial. BMJ Open. 2026 May 18;16(5):e114571. doi: 10.1136/bmjopen-2025-114571.
- Individual participant dataSharing planned: Yes. The study protocol with the statistical analysis plan will be available following publication.
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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.
Yiye Zhang, PhD principal investigator
Weill Medical College of Cornell University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support Tool in people with Postpartum Depression, run by Weill Medical College of Cornell University at 4 sites 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Rochelle Joly, MD (646-962-4222, roj9069@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability as measured by Unified Theory of Technology Acceptance Theory (UTAUT). (time frame: One month after initiation of tool use and three months after use.). 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 NCT06818734, which also lists 11 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 30 Jul 2026.