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OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Sep 1, 2026 → Sep 1, 2028
See other at-risk trials from Hackensack Meridian Health

Record History

  1. Notable Primary completion pushed from Sep 1, 2026 to Sep 1, 2028
    • Study completion pushed from Sep 1, 2027 to Sep 1, 2028
    v7
  2. Minor 2 versions Re-verified since Sep 15, 2025, no change to tracked fieldsv5-v6
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 1, 2025 to Sep 15, 2025
    • Site details revised
    v4
  4. Notable Start date: Aug 1, 2025 to Sep 1, 2025
    • Primary completion date: Aug 1, 2026 to Sep 1, 2026
    • Study completion date: Aug 1, 2027 to Sep 1, 2027
    v3
  5. Notable Start date: Jun 1, 2025 to Aug 1, 2025
    • Primary completion date: Jun 1, 2026 to Aug 1, 2026
    • Study completion date: Jun 1, 2027 to Aug 1, 2027
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06991166
Lead Sponsor Hackensack Meridian Health
Collaborators: New Jersey Health Foundation
Conditions
(from sponsor)
Post Partum Depression
Related terms Depression, Postpartum
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov