Childbirth Education Pilot Study

Summary

This study aims to investigate the effects of mindfulness training on prenatal maternal anxiety using a randomized controlled trial (RCT). An RCT of mindfulness training for prenatal anxiety has distinct clinical and scientific advantages.

The investigators will use the Mindfulness-Based Childbirth and Parenting (MBCP) intervention in this study to build on previous findings by focusing on anxiety in pregnancy while also teaching mindfulness skills shown to promote positive childbirth appraisals and sensitive parenting through mindful parenting skills that have been shown to be linked to maternal-infant stress physiology in other work.

This study will enroll pregnant women with elevated anxiety (N = 60) who will be randomly assigned to the MBCP condition (n = 30) or an active control condition (a treatment as usual (TAU) condition; n = 30) which is a standard childbirth education class. Mothers will be assessed pre- and post-intervention and postpartum. Infant multi-modal neuroimaging will occur at age 1 month, at home questionnaire follow-up will occur at age 3 months, and a behavioral observation of parenting and child social-emotional functioning will occur at age 12 months. The hypothesis is that there will be greater benefits from MBCP relative to TAU controls, and enhanced connectivity between the amygdala and relevant cortico-limbic areas in from MBCP relative to TAU controls.

Conditions

• Pregnancy
• Anxiety

Interventions

BEHAVIORAL

MBCP Childbirth Education Course

The MBCP program is a fully manualized childbirth and parenting preparation course. Developed in 1998 in a clinical context, MBCP is an enhanced version of the Mindfulness Based Stress Reduction (MBSR) program tailored for addressing the concerns of pregnancy and early parenting. Through MBCP, pregnant women and their partners learn mindfulness skills for coping with the anxiety and stress of pregnancy and parenting, and the pain and fear of childbirth. They are given explicit instruction in skills for cultivating positive emotion and developing mindful, sensitive parenting. MBCP groups meet weekly for 9 weeks, with a retreat day between weeks 6 and 7.

BEHAVIORAL

Non-MBCP Childbirth Education Course

TAU control participants will undergo standard (real-world) hospital- or community-based childbirth education that does not have a mindfulness focus. They will be able to choose whichever class they want from the list. If they prefer a class that is not on the list, then study staff will obtain the syllabus for that class to check whether there is a mindfulness component.

Sponsors & Collaborators

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• Larissa Duncan, PhD · Center for Healthy Minds

• Sarah Short, PhD · Center for Healthy Minds

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-07-02

Primary Completion

2027-11-30

Completion

2027-11-30

Countries

• United States

Study Locations