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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Efficacy of a Prenatal Yoga Intervention for Antenatal Depression

Conditions
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Pregnancy

Intervention / Treatment
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* Behavioral: Prenatal Yoga
* Behavioral: Mother Baby Wellness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy singleton pregnancy, 12-27 weeks gestation Medically cleared for moderate exercise Depression symptoms in moderate range. Participants must have an Quick Inventory of Depressive Symptoms (QIDS; [119]) score between 8-20 English-speaking Aged 18 or older Exclusion Criteria: New or unstable depression treatment Currently a regular yoga practitioner Bipolar disorder, schizophrenia, psychotic depression, chronic psychosis Current hazardous drug or alcohol use Acute suicidality

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prenatal Yoga<br>A 9-week prenatal yoga program | Behavioral: Prenatal Yoga<br>* As part of the yoga program, participants will be asked to go to one 75-minute prenatal yoga class each week for 9 weeks. The yoga classes will be designed to be safe for pregnant women. In addition to classes, the yoga teacher will ask them to practice yoga at home during the program. Each participant will be given a yoga mat and a prenatal yoga DVD to take home.<br>|
| Active Comparator: Mother Baby Wellness Workshop<br>A 9-week workshop on mother and baby wellness in the first postpartum year | Behavioral: Mother Baby Wellness<br>* This workshop is aimed at promoting moms' and babies' good health and will involve attending one 75-minute class each week for 9 weeks. Classes will cover topics such as: child development in the first year, child eating and sleeping in the first year, maintaining good health as a mom of an infant, and recent advances in women's healthcare. In addition to classes, participants will be given materials to review/ read at home.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Inventory of Depression Symptoms - Clinician Rating | Clinician-rated depression severity | Baseline to 9-week end point | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edinburgh Postnatal Depression Screen | Self-reported depression severity | Baseline to 9-week endpoint | 
| State-Trait Anxiety Inventory | Anxiety level | Baseline to 9-week endpoint | 
| Pittsburgh Sleep Quality Index | Sleep disturbance | Baseline to 9-week endpoint | 
| Maternal & Neonatal Outcomes Checklist (MNOC) | rates of preterm birth | 30 days postpartum |