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NCT06991166 · ClinicalTrials.gov registry record · NA

OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression

A NA study of Post Partum Depression, sponsored by Hackensack Meridian Health.

Recruiting
Registry status
NA
Development phase
72
Enrollment target
1
Study location

NCT06991166 is a NA study of Post Partum Depression that is actively recruiting participants, run by Hackensack Meridian Health. The registered enrollment target is 72 participants, below the 227-participant average among 9 other Post Partum Depression trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06991166, a NA study of Post Partum Depression, is actively recruiting participants, sponsored by Hackensack Meridian Health.

RECRUITING
Registry status
NA
Development phase
72 participants
Enrollment target
1
Study location

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 Studied

Interventions

  • BEHAVIORAL Cognitive behavioral therapy (CBT) psychotherapy group/telehealth
  • BEHAVIORAL Interpersonal therapy (IPT) psychotherapy group/telehealth

Study Locations (1)

New Jersey

  • Hackensack University Medical Center - Hackensack

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2025-09-15
Est. Completion 2027-09-01
Phase NA

Sponsor

Hackensack Meridian Health

90 total trials

What the Registry Record Tells You About NCT06991166

The ClinicalTrials.gov registry entry for NCT06991166 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 227-participant average among 9 other Post Partum Depression trials with a reported enrollment target (68% lower). The listed sponsor is Hackensack Meridian Health, which has 90 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Post Partum Depression appearing as the primary indexed condition, and to 2 interventions - of which Cognitive behavioral therapy (CBT) psychotherapy group/telehealth is the first listed.

NCT06991166 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.

Frequently Asked Questions

What is clinical trial NCT06991166 about?

NCT06991166 is a clinical study titled "OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression". 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 res...

What is the current status of trial NCT06991166?

This trial is currently recruiting. It is a NA study. The enrollment target is 72 participants. The study started on 2025-09-15. Estimated completion is 2027-09-01.

What conditions does trial NCT06991166 study?

This clinical trial studies the following conditions: Post Partum Depression.

What interventions are being tested in trial NCT06991166?

The interventions under investigation include: Cognitive behavioral therapy (CBT) psychotherapy group/telehealth (BEHAVIORAL), Interpersonal therapy (IPT) psychotherapy group/telehealth (BEHAVIORAL).

Who is sponsoring clinical trial NCT06991166?

This trial is sponsored by Hackensack Meridian Health, which has 90 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06991166 being conducted?

This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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