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NCT06991166 · ClinicalTrials.gov registry record · NA
OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression
A NA study of Postpartum Depression, sponsored by Hackensack Meridian Health.
- Recruiting
- Registry status
- NA
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT06991166: Recruiting NA study of Postpartum Depression, sponsored by Hackensack Meridian Health.
NCT06991166 is a NA study of Postpartum Depression that is actively recruiting participants, run by Hackensack Meridian Health. The registered enrollment target is 72 participants, below the 474-participant average among 47 other Postpartum Depression trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06991166, a NA study of Postpartum 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.
Primary Outcome
Quantitative assessment of treatment effectiveness in reducing PPD symptoms will be conducted with the Edinburgh Postnatal Depression Scale (EPDS), a 10-item validated self-report scale. Total scores on the EPDS range from 0 to 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. The measures will be administered at the following timepoints: Week 0 Baseline: At study entry prior to starting group psychotherapy in the Outpatient Behavior
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
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2025-09-15 |
| Est. Completion | 2027-09-01 |
| Phase | NA |
What NCT06991166 shows while recruiting
NCT06991166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 474-participant average among 47 other Postpartum Depression trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Postpartum 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 a single indexed study location in 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: Postpartum 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.
Learn More About Clinical Trials
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Where NCT06991166's enrollment target sits among peer trials
72 33rd of 47 higher than 15 of 47 other Postpartum Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postpartum Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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