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

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Behavioral: Prenatal Yoga; Behavioral: Mother Baby Wellness

• Registration Number: NCT02738216
• Lead Sponsor: Butler Hospital

Brief Summary

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

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).

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-14
• Primary Completion: 2022-11
• Study Completion: 2022-11
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 178

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prenatal Yoga	Prenatal Yoga	A 9-week prenatal yoga program
Mother Baby Wellness Workshop	Mother Baby Wellness	A 9-week workshop on mother and baby wellness in the first postpartum year

Primary Outcome Measures

Name	Time	Method
Quick Inventory of Depression Symptoms - Clinician Rating	Baseline to 9-week end point	Clinician-rated depression severity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States