NCT06991166 · Hackensack Meridian Health
OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Cognitive 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
BEHAVIORAL
Interpersonal therapy (IPT) psychotherapy group/telehealth
Type of psychotherapy. IPT focuses on improving interpersonal communication and deficits, processing grief, and role transitions
Primary outcome measures
Post Partum Depression post initial psychotherapy
Time frame: At 4 weeks
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 Behavioral Health practice Week 4: After completing the first 4-week intervention of the two-intervention sequence, prior to "crossing over"
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.)
Where
- Hackensack, New Jersey
Collaborators
New Jersey Health Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 11, 2026 · Source of record for eligibility and locations