Routine vs. Early Postpartum Depression Screening: A Pragmatic Clinical Trial

NCT07460063 | Not Yet Recruiting

• 1 other identifier: 2025P003281
• Study Type: interventional
• Target: 428
• Locations: 0 countries
• Sites: N/A

Brief Summary

After having a baby, some women develop a condition called postpartum depression, or PPD, which can cause sadness, anxiety, and difficulty bonding with their newborn. Right now, most women aren't screened for PPD until about 6 to 8 weeks after giving birth, but this study wants to find out if checking earlier could help identify signs sooner. To test this, researchers will work with 428 women who deliver at an MGH hospital clinic and have no history of depression. Each woman will be randomly placed into one of two groups: one group will fill out a short depression questionnaire online at 2 to 3 weeks after delivery, while the other group will follow the usual process and complete the same questionnaire at their regular 6-week visit. The results will go to each woman's doctor, who will decide if any follow-up care is needed, just like they normally would. The study will follow each participant for 6 months after delivery to see whether earlier screening makes a difference.

Conditions

Postpartum Depression (PPD)

Keywords

postpartum; depression; depression screening

Outcome Measures

Primary Outcomes (2)

• Proportion of positive Edinburgh Postnatal Depression Scale (EPDS) screens at 6 weeks in the routine care group by postpartum depression (PPD) risk status

  To compare rates of positive EPDS screens (EPDS \>12) at 6 weeks (in the routine care group) by PPD risk status (high vs. low)

  6 weeks postpartum is defined as a period between 28-56 days after the day of delivery

• Edinburgh Peripartum Depression Scale (EPDS) scores at 2 weeks postpartum in the early screening group by PPD risk status

  To compare EPDS scores at 2 weeks postpartum by PPD risk status (high vs. low) in the early screening group. EPDS score: range 0-30; higher scores are more strongly associated with PPD

  2 weeks postpartum is defined as a period between 8-24 days after the day of delivery

Secondary Outcomes (15)

• Edinburgh Postnatal Depression Scale (EPDS) score at 6 weeks in the routine screening group by PPD risk status (high vs. low).

  6 weeks postpartum is defined as a period between 28-56 days after the day of delivery

• Proportion of individuals with PPD at 6 months postpartum in the routine care group by PPD risk status

  6 months postpartum is defined as a period between the day of delivery and 180 days after delivery

• Proportion of individuals with PPD at 6 months postpartum in the early screening group by PPD risk status

  6 months postpartum is defined as a period between the day of delivery and 180 days after delivery

• Proportion of individuals with PPD (excluding EPDS diagnositic criteria) at 6 months postpartum in the routine care group by PPD risk status

  6 months postpartum is defined as a period between the day of delivery and 180 days after delivery

• Proportion of individuals with PPD (excluding EPDS diagnostic criteria) at 6 months postpartum in the early screening group by PPD risk status

  6 months postpartum is defined as a period between the day of delivery and 180 days after delivery

Study Arms (4)

Early Screening among High-Risk Participants

EXPERIMENTAL

Early PPD screening among individuals identified at high risk for PPD

Behavioral: Early PPD Screening

Routine Care among High-Risk Participants

NO INTERVENTION

Routine care among individuals identified at high risk for PPD

Early Screening among Low-Risk Participants

EXPERIMENTAL

arly PPD screening among individuals identified at low risk for PPD

Behavioral: Early PPD Screening

Routine Care among Low-Risk Participants

NO INTERVENTION

Routine care among individuals identified at low risk for PPD

Interventions

Early PPD Screening BEHAVIORAL

Edinburgh Perinatal Depression Scale (EPDS) administered at approximately 2 weeks postpartum

Early Screening among High-Risk Participants; Early Screening among Low-Risk Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Live birth, term (≥37 weeks) delivery at Massachusetts General Hospital
• Access to Patient Gateway, as to receive the electronic EPDS scale
• Primary obstetric provider at MGH or its affiliated clinics
• No recent history of depressive disorder as determined through diagnoses or medication use\*
• Age ≥18 years old

You may not qualify if:

• A diagnosis code in the EHR for major depressive disorder, bipolar disorder, or psychotic disorder within the year prior to delivery
• Antidepressant, antipsychotic, or bipolar medication use within the year prior to delivery
• Age \<18 years old

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Related Publications (1)

• Clapp MA, Castro VM, Verhaak P, McCoy TH, Shook LL, Edlow AG, Perlis RH. Stratifying Risk for Postpartum Depression at Time of Hospital Discharge. Am J Psychiatry. 2025 Jun 1;182(6):551-559. doi: 10.1176/appi.ajp.20240381. Epub 2025 May 19.

  PMID: 40384019 RESULT

MeSH Terms

Conditions

Depression, Postpartum; Depression

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Roy H Perlis, MD, MSc

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Mark A Clapp, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark A Clapp, MD, MPH

CONTACT

617-726-2000; mark.clapp@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Care provider will know if the participant is in the early vs. routine screening group, though they will not know if the patient is at high or low risk for postpartum depression (based on the prediction model).
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05