Group cognitive behavioral therapy versus interpersonal therapy for postpartum depression in NICU mothers
Official title: OBWELL: Evaluating the Effectiveness of an Innovative Psychotherapeutic Intervention to Treat Postpartum Depression Among High-Risk Mothers
Run by Hackensack Meridian Health · NCT06991166 · Data updated 2026-11-12
This project will test whether group CBT or group IPT, delivered in person or by telehealth, helps reduce postpartum depression symptoms in mothers with infants in the NICU.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 72 (estimated) |
| Sponsor | Hackensack Meridian Health Academic / other |
| Locations | 1 site (Hackensack, New Jersey) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | September 1, 2028 |
| Study ends | September 1, 2028 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT06991166 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English-speaking mothers aged 18+ who gave birth 24 hours to 12 months ago, have an infant currently in the NICU, and have current or prior major depressive disorder or elevated EPDS scores.
✕Probably not a fit
Patients with active substance dependency, acute suicidal or infanticidal ideation, current psychosis, significant cognitive impairment, recent infant death, or who cannot attend sessions are unlikely to benefit or be eligible for participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study enrolls English-speaking mothers over age 18 who gave birth 24 hours to 12 months prior and whose newborn is in the NICU, and randomizes them to group cognitive behavioral therapy (CBT) or group interpersonal therapy (IPT) delivered either in person or by telehealth. Depression is identified by current or prior major depressive disorder or elevated EPDS scores, and participants with active substance dependence, acute suicidal/infanticidal ideation, psychosis, or cognitive impairment are excluded. Outcomes focus on changes in depressive symptoms and treatment engagement across the intervention period, with attendance and completion tracked to measure feasibility. The intervention emphasizes evidence-based psychotherapy adapted for mothers experiencing the stress of a NICU admission.
Why it matters
Potential benefit: If successful, this approach could offer an accessible, evidence-based group psychotherapy option (in person or by telehealth) that reduces depressive symptoms and improves maternal and infant outcomes for NICU mothers.
How similar studies have gone: CBT and IPT are established, effective psychotherapies for postpartum depression generally, but randomized trials specifically focused on mothers of NICU infants are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Mother of NICU infant
* Older than age 18
* English-speaking
* Gave birth more than 24 hours ago and less than 12 months prior to enrollment
* Depression as assessed by:
Current/Prior diagnosis of Major Depressive Disorder OR EPDS score above 10 OR EPDS score below 10 AND Endorsement of "sometimes" or "often" on item #10 on the EPDS\* ("I have had thoughts of harming myself")
Exclusion Criteria:
* A diagnosis of Substance Dependency or Substance Use
* Acute suicidal or infanticidal ideation
* Current psychosis
* Medical history of cognitive impairment
* Infant death of current NICU admission
* Marked non-compliance with intervention (e.g, non-attendance of more than one session during a 4-week intervention or failure to complete study assessments),
* Are in medical treatment that would prevent participation (i.e., medical treatment that requires inpatient hospitalization and thus would prevent participation of study visits.)
Where it's running
-
Hackensack University Medical Center
Hackensack, New Jersey, United States Recruiting
Study contacts
- Principal investigator: Yeraz Markarian, PhD — Hackensack Meridian Health
- Study coordinator: Melissa Giuliano, LMSW
- Email: Melissa.Giuliano@hmhn.org
- Phone: 5519964450
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.