What side effects are associated with this type of intervention?

Common treatments for Postpartum Depression (PPD) include antidepressants, psychotherapy, and Mindfulness-Based Cognitive Therapy (MBCT). Antidepressants can cause side effects such as nausea, fatigue, and sexual dysfunction. Psychotherapy, including cognitive-behavioral therapy (CBT), generally has fewer physical side effects but may cause emotional discomfort. MBCT, which combines mindfulness practices with cognitive therapy, typically has minimal side effects, though some individuals may initially experience increased anxiety or emotional discomfort.

What prior FDA approvals exist?

The FDA has approved brexanolone (Zulresso) and, more recently, zuranolone for the treatment of Postpartum Depression (PPD). These medications are neuroactive steroids that modulate GABA receptors, providing rapid relief from depressive symptoms. Unlike these pharmacological treatments, Mindfulness-Based Cognitive Therapy (MBCT) is a non-drug approach that combines mindfulness practices with cognitive therapy techniques to help individuals manage psychological distress by promoting awareness and acceptance of thoughts and feelings without judgment. While MBCT is not FDA-approved, it is studied for its potential benefits in managing PPD symptoms.

What other types of research exist?

Promising, novel alternatives to Mindfulness-Based Cognitive Therapy for postpartum depression patients include: 1) Cognitive Behavioral Therapy (CBT), which focuses on changing negative thought patterns and behaviors; 2) Interpersonal Therapy (IPT), which addresses interpersonal issues and social functioning; 3) Pharmacotherapy, including the use of antidepressants such as SSRIs; 4) Integrative therapies like yoga and acupuncture, which have shown benefits in reducing stress and improving mood; and 5) Digital mental health interventions, such as app-based CBT and online support groups, which provide accessible and flexible treatment options.

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Behavioral Intervention

Mindfulness-Based Cognitive Therapy for Psychological Distress During Pregnancy

N/A

Recruiting

Led By Michele Levine, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Symptom severity necessitating a higher level of clinical care

Untreated mania

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks to 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how Mindfulness-Based Cognitive Therapy (MBCT) helps pregnant women manage their thoughts and emotions to reduce psychological distress. The goal is to see if MBCT improves mental health during pregnancy and if these benefits last after childbirth. Mindfulness-Based Cognitive Therapy (MBCT) has been shown to be effective in reducing depression and anxiety in pregnant women.

Who is the study for?

This trial is for pregnant individuals in the U.S. between 12 and 30 weeks along, experiencing mild psychological distress. They must have internet or cellular access. It's not for those with severe mental health issues like untreated mania, current psychosis, active substance abuse, or suicidal thoughts.

What is being tested?

The study compares Mindfulness-Based Cognitive Therapy (MBCT) to usual treatment methods during pregnancy and postpartum to understand how MBCT improves well-being and manages psychological distress during these periods.

What are the potential side effects?

Mindfulness-based therapies are generally considered safe but may bring up emotional discomfort as participants become more aware of their feelings. There are no known significant physical side effects.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My symptoms are severe and need more advanced care.

Select...

I have not received treatment for mania.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in anxiety symptoms from 8 weeks to 3 months

Change in anxiety symptoms from baseline to 8 weeks

Change in mindfulness from 8 weeks to 3 months

+8 more

Secondary study objectives

Change in attention from 8 weeks to 3 months

Change in attention from baseline to 8 weeks

Change in cognitive inflexibility from 8 weeks to 3 months

+5 more

Other study objectives

Engagement (attendance) at 8 weeks

Engagement (homework) at 8 weeks

Participant satisfaction at 3 months

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness-Based Cognitive Therapy (MBCT)Experimental Treatment1 Intervention

MBCT will be delivered in a group based, videoconference format with 90 minute sessions 1x/week.

Group II: Treatment as Usual (TAU)Active Control1 Intervention

TAU, or the control group, provides information about the benefits of mindfulness in pregnancy, offers referrals for psychotherapy in the community, and involves monthly phone or videoconference calls to maintain engagement.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness-Based Cognitive Therapy (MBCT)

2014

N/A

~180

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mindfulness-Based Cognitive Therapy (MBCT) for Postpartum Depression (PPD) combines mindfulness practices with cognitive therapy techniques to manage psychological distress. This approach promotes awareness and acceptance of thoughts and feelings without judgment, helping to reduce negative thought patterns and emotional reactivity. MBCT also aids in developing coping strategies and resilience, which are crucial for managing the stress and emotional challenges of the postpartum period. This non-pharmacological option is particularly beneficial for PPD patients who may be breastfeeding or prefer to avoid medication.

Effectiveness of mindfulness-based cognitive therapy for comorbid depression and anxiety in pregnancy: a randomized controlled trial.