RecruitingNot ApplicableNCT06991166

OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression

OBWELL: Evaluating the Effectiveness of an Innovative Psychotherapeutic Intervention to Treat Postpartum Depression Among High-Risk Mothers


Sponsor

Hackensack Meridian Health

Enrollment

72 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new psychotherapy program (called OBWELL) specifically designed for mothers of babies in the neonatal intensive care unit (NICU) who are experiencing postpartum depression. **You may be eligible if...** - You are a mother (aged 18 or older) whose baby is currently in the NICU - You gave birth more than 24 hours ago and less than 12 months ago - You have a diagnosis of major depression, or scored above 10 on a standard postpartum depression screening tool - You speak English **You may NOT be eligible if...** - You have a substance use disorder - You have active suicidal thoughts or thoughts of harming your baby - You are currently experiencing psychosis - You have significant cognitive impairment - Your baby has died during this NICU admission Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive 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

BEHAVIORALInterpersonal therapy (IPT) psychotherapy group/telehealth

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


Locations(1)

Hackensack University Medical Center

Hackensack, New Jersey, United States

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NCT06991166


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