Wellness for 2: Understanding How to Foster Well Being for Mom and Her Baby (WF2)

Butler Hospital

Status: Completed

Conditions: Pregnancy

Treatments: Behavioral: Prenatal Yoga; Behavioral: Mother Baby Wellness

Study type: Interventional

Funder types: Other

Identifiers

NCT02738216

R01HD081868

Details and patient eligibility

About

This NICHD-funded RCT will enroll up to 178 depressed pregnant women, randomly assigning them to one of 2 intervention conditions: (1) a gentle prenatal yoga program (PYP), or (2) a series of educational workshops focused on perinatal health, the Mom and Baby Wellness Workshop (MBWW), each condition lasting 9 weeks. The investigators will clinically monitor all participants in the study for safety and clinical deterioration, and measure a variety of symptom outcomes over the course of the intervention period during pregnancy, as well as at a postpartum follow-up.

Full description

In this randomized controlled trial, eligible women will be randomly assigned to either a 9-week Prenatal Yoga Program (PYP) vs. a 9-week health education control group, the Mother-Baby Wellness Workshop (MBWW). Follow up assessments will take place at multiple points during the study. The primary study outcome will be severity of prenatal depression assessed by a blind interviewer. The investigators will examine relevant secondary outcomes (self-reported depression, anxiety, functioning, & pain; pre-term birth) and potential mediators (inflammation, mindfulness/non-judgment).

Enrollment: 178 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Healthy singleton pregnancy, 12-27 weeks gestation
2. Medically cleared for moderate exercise
3. Depression symptoms in moderate range. Participants must have an Quick Inventory of Depressive Symptoms (QIDS; [119]) score between 8-20
4. English-speaking
5. Aged 18 or older

Exclusion criteria

1. New or unstable depression treatment
2. Currently a regular yoga practitioner
3. Bipolar disorder, schizophrenia, psychotic depression, chronic psychosis
4. Current hazardous drug or alcohol use
5. Acute suicidality

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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178 participants in 2 patient groups

Prenatal Yoga

Experimental group

Description:

A 9-week prenatal yoga program

Treatment:

Behavioral: Prenatal Yoga

Mother Baby Wellness Workshop

Active Comparator group

Description:

A 9-week workshop on mother and baby wellness in the first postpartum year

Treatment:

Behavioral: Mother Baby Wellness