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OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression

OBWELL: Evaluating the Effectiveness of an Innovative Psychotherapeutic Intervention to Treat Postpartum Depression Among High-Risk Mothers

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two kinds of talk therapy for depression after childbirth in mothers whose babies are in the NICU, a special care unit for sick newborns. It tests cognitive behavioral therapy (CBT), which focuses on thoughts and behaviors, and interpersonal therapy (IPT), which focuses on relationships. It compares 4 weeks of either therapy with 8 weeks of both therapies, given one after the other.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are the mother of a baby in the NICU.
  • You are older than 18.
  • You speak English.
  • You gave birth more than 24 hours ago but less than 12 months before joining.
  • You have a current or past diagnosis of major depression; score above 10 on the EPDS, a depression questionnaire; or score below 10 and answer “sometimes” or “often” to its question about thoughts of harming yourself.

Who can't join

  • You have a diagnosis of substance use or dependence.
  • You have current, urgent thoughts of suicide or killing your baby.
  • You currently have psychosis, which can make it hard to tell what is real.
  • You have a history of problems with thinking or memory.
  • Your baby died during the current NICU stay.
  • You miss more than one session during a 4-week treatment or do not complete study assessments.
  • You receive medical treatment that prevents you from taking part, such as treatment requiring a hospital stay.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.)

Study sites (1)

NJ