Actively Recruiting
OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression
Led by Hackensack Meridian Health · Updated on 2026-02-11
72
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
H
Hackensack Meridian Health
Lead Sponsor
N
New Jersey Health Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Postpartum Depression (PPD) is defined as depression that occurs after childbirth, with intense symptoms that last longer than "baby blues". PPD differs greatly from "baby blues", a term used to describe the typical sadness, worry and tiredness that women experience after childbirth, which often resolves within a week or two on its own. The symptoms of PPD interfere with many aspects of daily living and can have unhealthy short-term and long-term outcomes, both for the mother and baby. One-third of women in the U.S. with PPD are identified in clinical settings, yet only half of those begin psychotherapy treatment. Unfortunately, mothers whose newborns are in the Neonatal Intensive Care Unit (NICU) are at high risk for developing PPD, necessitating early identification and evidence-based treatment. Cognitive behavioral therapy (CBT) and interpersonal therapy (IPT) are the two most effective psychotherapy treatments for PPD, yet no randomized controlled clinical trials were found that directly compared the two types of treatment or determined whether combining the two approaches is more helpful for PPD than either approach alone. This clinical trial aims to compare the effectiveness of a 4-week intervention of either CBT or IPT for PPD in NICU mothers and to determine whether a sequential 8-week intervention (IPT then CBT, or CBT then IPT) is more beneficial.
CONDITIONS
Official Title
OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mother of NICU infant
- Age 18 or older
- English-speaking
- Gave birth more than 24 hours ago and less than 12 months ago
- Current or prior diagnosis of Major Depressive Disorder OR EPDS score above 10 OR EPDS score below 10 with endorsement of "sometimes" or "often" on item #10 of the EPDS (thoughts of self-harm)
You will not qualify if you...
- Diagnosis of substance dependency or substance use
- Acute suicidal or infanticidal thoughts
- Current psychosis
- Medical history of cognitive impairment
- Death of current NICU infant
- Marked non-compliance with intervention (missing more than one session during 4-week treatment or failure to complete assessments)
- Receiving medical treatment requiring inpatient hospitalization that prevents study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
Research Team
M
Melissa Giuliano, LMSW
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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