72 Participants Needed

Psychotherapy for Postpartum Depression

MG
Overseen ByMelissa Giuliano, LMSW
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Hackensack Meridian Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of two therapies—Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT)—in treating postpartum depression (PPD) in mothers with babies in the Neonatal Intensive Care Unit (NICU). It compares a 4-week session of each therapy individually with an 8-week session that combines both therapies. This trial suits mothers with an infant in the NICU who are experiencing postpartum depression. As an unphased trial, it provides a unique opportunity for mothers to explore new therapeutic approaches tailored to their specific needs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT) are generally safe for treating postpartum depression. Studies on CBT have found it well-tolerated, with many women experiencing symptom relief and few side effects. For instance, online and app-based CBT programs have effectively helped women with postpartum depression, indicating it is a safe option.

Similarly, IPT has a strong safety record. Research indicates that women who undergo IPT for postpartum depression often see significant improvements in their symptoms. Specifically, women receiving IPT are much less likely to remain clinically depressed. These findings suggest that IPT is also well-tolerated, with no major negative effects reported.

In summary, both CBT and IPT are considered safe and effective for treating postpartum depression, with studies supporting their use without significant safety concerns.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for postpartum depression because they combine Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT) in a novel way. Unlike standard treatments that often rely solely on medication or a single type of therapy, this approach uses a cross-over method, allowing participants to benefit from both CBT and IPT. This unique combination may provide more comprehensive support by addressing both cognitive patterns and social dynamics, potentially leading to better outcomes for new mothers. Plus, the use of telehealth makes these therapies more accessible, offering flexibility for participants to receive support from the comfort of their homes.

What evidence suggests that this trial's treatments could be effective for postpartum depression?

Research has shown that Cognitive Behavioral Therapy (CBT), one of the therapies under study in this trial, effectively treats postpartum depression (PPD). One study found that even a single day of online CBT improved PPD symptoms in mothers. Traditional CBT has also proven effective in reducing depression, anxiety, and stress in new mothers.

Interpersonal Therapy (IPT), the other therapy under study, also benefits those with PPD. Studies indicate that women who received IPT were 4.5 times less likely to remain clinically depressed. IPT effectively reduces depressive symptoms, enhancing mood and well-being in postpartum women.

Both therapies have strong evidence supporting their effectiveness for PPD, making them promising options for those experiencing this condition. Participants in this trial will receive both therapies in a cross-over design to evaluate their effectiveness.12367

Who Is on the Research Team?

YM

Yeraz Markarian, PhD

Principal Investigator

Hackensack Meridian Health

Are You a Good Fit for This Trial?

This trial is for mothers with Postpartum Depression (PPD) whose newborns are in the Neonatal Intensive Care Unit (NICU). Participants should be experiencing PPD symptoms that affect daily life. The study seeks to include those who have not yet started psychotherapy treatment.

Inclusion Criteria

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')
English-speaking
See 2 more

Exclusion Criteria

Current psychosis
Medical history of cognitive impairment
Infant death of current NICU admission
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive either a 4-week CBT or IPT intervention

4 weeks
Telehealth sessions

Crossover Treatment

Participants cross over to the second 4-week intervention (IPT or CBT)

4 weeks
Telehealth sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Assessment at 6 months post enrollment

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Behavioral Therapy (CBT)
  • Interpersonal Therapy (IPT)
Trial Overview The OBWELL trial tests Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT) delivered via telehealth over 4 weeks. It compares their effectiveness separately and explores if an 8-week sequential combination of both therapies offers greater benefits for treating PPD in NICU mothers.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: 4-week interpersonal therapy (IPT) psychotherapy group/telehealth interventionExperimental Treatment2 Interventions
Group II: 4-week Cognitive behavioral therapy (CBT) psychotherapy group/telehealth interventionExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials
141
Recruited
42,900+

New Jersey Health Foundation

Collaborator

Citations

The Effects of Online Cognitive Behavioral Therapy on ...Background/Objectives: Postpartum depression seriously affects the safety and health of mothers and children. Online cognitive behavioral therapy is ...
2.samhsa.govsamhsa.gov/
Home | SAMHSA - Substance Abuse and Mental Health ...SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.
Effectiveness of cognitive behavioral therapy for perinatal ...Overall, CBT is effective for perinatal maternal depression, anxiety and stress. · CBT-only is effective for perinatal depression in low-income women. · Partner- ...
Effectiveness of cognitive behavioural therapy-based ...Although existing evidence suggests cognitive behavioral therapy (CBT) based interventions are effective for perinatal depression, less is known ...
Effect of Online 1-Day Cognitive Behavioral Therapy ...In this randomized clinical trial of 403 mothers, online 1-day CBT-based workshops led to clinically and statistically significant improvements in PPD and ...
Effectiveness of an app-based cognitive behavioral therapy ...The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression.
Internet Cognitive Behavioral Therapy for Women With ...Background: There are few published controlled trials examining the efficacy of Internet-based treatment for postnatal depression (PND) and ...
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