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

Pregnancy Clinical Trial

— WF2  

Official title:

Efficacy of a Prenatal Yoga Intervention for Antenatal Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738216
• Other study ID #: R01HD081868
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: November 2022

Study information

• Verified date: December 2022
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Butler Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quick Inventory of Depression Symptoms - Clinician Rating	Clinician-rated depression severity	Baseline to 9-week end point
Secondary	Edinburgh Postnatal Depression Screen	Self-reported depression severity	Baseline to 9-week endpoint
Secondary	State-Trait Anxiety Inventory	Anxiety level	Baseline to 9-week endpoint
Secondary	Pittsburgh Sleep Quality Index	Sleep disturbance	Baseline to 9-week endpoint
Secondary	Maternal & Neonatal Outcomes Checklist (MNOC)	rates of preterm birth	30 days postpartum