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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02738216
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Butler Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pregnancy Behavioral: Prenatal Yoga Behavioral: Mother Baby Wellness Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Prenatal Yoga Intervention for Antenatal Depression
Study Start Date : March 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Quick Inventory of Depression Symptoms - Clinician Rating [ Time Frame: Baseline to 9-week end point ]
    Clinician-rated depression severity


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738216


Contacts
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Contact: Rita Rossi, MA 401-455-6377 rrossi@butler.org

Locations
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United States, Rhode Island
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Cynthia Battle, PhD    401-455-6371    cynthia_battle@brown.edu   
Sponsors and Collaborators
Butler Hospital
Investigators
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Principal Investigator: Cynthia Battle, PhD Butler Hospital
More Information
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Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT02738216    
Other Study ID Numbers: R01HD081868 ( U.S. NIH Grant/Contract )
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No