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OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression

RecruitingNAAges 18 Years - anyFemaleHackensack Meridian Health
NCT06991166 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 effect

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📋 Eligibility rules (as published)
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.)
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What it tests

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

1 site
Hackensack University Medical Center
Hackensack, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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