Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06991166

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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)
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here