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Completed

NCT Number: NCT02738216

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

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.

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prenatal yoga

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Quick Inventory of Depression Symptoms - Clinician Rating

    Time frame: Baseline to 9-week end point

    Clinician-rated depression severity

Secondary outcomes

  1. Edinburgh Postnatal Depression Screen

    Time frame: Baseline to 9-week endpoint

    Self-reported depression severity

  2. State-Trait Anxiety Inventory

    Time frame: Baseline to 9-week endpoint

    Anxiety level

  3. Pittsburgh Sleep Quality Index

    Time frame: Baseline to 9-week endpoint

    Sleep disturbance

  4. Maternal & Neonatal Outcomes Checklist (MNOC)

    Time frame: 30 days postpartum

    rates of preterm birth

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Registry information

Official study title

Efficacy of a Prenatal Yoga Intervention for Antenatal Depression

Acronym: WF2

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2016
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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