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OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression

NCT06991166 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-02-11

No results posted yet for this study

Summary

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

  • Post Partum Depression

Interventions

BEHAVIORAL

Cognitive behavioral therapy (CBT) psychotherapy group/telehealth

Type of psychotherapy. CBT focuses on identifying and changing unhelpful beliefs and behavioral patterns that lead to negative emotions (e.g., depression, anxiety, grief, shame) in order to break the emotion-thought-behavior cycle

BEHAVIORAL

Interpersonal therapy (IPT) psychotherapy group/telehealth

Type of psychotherapy. IPT focuses on improving interpersonal communication and deficits, processing grief, and role transitions

Sponsors & Collaborators

  • New Jersey Health Foundation

    collaborator OTHER

  • Hackensack Meridian Health

    lead OTHER

Principal Investigators

  • Yeraz Markarian, PhD · Hackensack Meridian Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-09-01
Completion
2027-09-01

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06991166 on ClinicalTrials.gov