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

Efficacy of a Prenatal Yoga Intervention for Antenatal Depression

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Behavioral: Prenatal Yoga; Behavioral: Mother Baby Wellness

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 Type: Interventional
• Enrollment (Anticipated): 178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prenatal Yoga; A 9-week prenatal yoga program	Behavioral: Prenatal Yoga; 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.
Active Comparator: Mother Baby Wellness Workshop; A 9-week workshop on mother and baby wellness in the first postpartum year	Behavioral: Mother Baby Wellness; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Butler Hospital
• Investigators: Principal Investigator: Cynthia Battle, PhD, Butler Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 13, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: R01HD081868 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No