No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
72 (estimated)
Sponsor
Hackensack Meridian Health · Other
Who this trial is looking for
This trial is looking for mothers of infants in the NICU who are experiencing postpartum depression. Participants will be involved in therapy sessions using either cognitive behavioral therapy or interpersonal therapy to help with their symptoms.
Are You a Good Fit for This Trial?
You may be able to join if
I am a mother of a NICU infant.
I am older than 18 years.
I speak English.
I gave birth more than 24 hours ago and less than 12 months ago.
I have been diagnosed with major depressive disorder.
I have a score above 10 on the EPDS.
I have a score below 10 on the EPDS and have had thoughts of harming myself 'sometimes' or 'often'.
You may not be able to join if
I have a diagnosis of substance dependency or substance use.
I have acute suicidal or infanticidal thoughts.
I have current psychosis.
I have a medical history of cognitive impairment.
My infant died during the current NICU admission.
I have not attended more than one therapy session during a 4-week intervention.
I am receiving medical treatment that prevents my participation.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 livi…
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.
Trial Locations
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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 End…
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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