Status:

RECRUITING

OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression

Lead Sponsor:

Hackensack Meridian Health

Collaborating Sponsors:

New Jersey Health Foundation

Conditions:

Post Partum Depression

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief 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 descr...

Eligibility Criteria

Inclusion

  • 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

  • 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.)

Key Trial Info

Start Date :

September 15 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2027

Estimated Enrollment :

72 Patients enrolled

Trial Details

Trial ID

NCT06991166

Start Date

September 15 2025

End Date

September 1 2027

Last Update

September 16 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601