Pregnancy
Conditions
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).
Interventions
BEHAVIORALPrenatal 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.
BEHAVIORALMother 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.
Sponsors
Butler Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quick Inventory of Depression Symptoms - Clinician Rating | Baseline to 9-week end point | Clinician-rated depression severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Edinburgh Postnatal Depression Screen | Baseline to 9-week endpoint | Self-reported depression severity |
| State-Trait Anxiety Inventory | Baseline to 9-week endpoint | Anxiety level |
| Pittsburgh Sleep Quality Index | Baseline to 9-week endpoint | Sleep disturbance |
| Maternal & Neonatal Outcomes Checklist (MNOC) | 30 days postpartum | rates of preterm birth |
Countries
United States
Outcome results
None listed