Thursday, November 21, 2024
11/21/2024
DESCRIPTION DESCRIPTION (provided by applicant): This R01 resubmission "Efficacy of a Prenatal Yoga Intervention for Antenatal Depression" is in response to NICHD PA-12-216, Women's Mental Health During Pregnancy and the Postpartum Period. Antenatal depression is common and associated with adverse outcomes for mother and child, yet the majority of affected women do not receive any mental health treatment. Pregnant women have unique concerns about treatment acceptability and are often reluctant to take antidepressants, the most widely available form of depression care. Prenatal yoga is an excellent candidate for a depression intervention that might be efficacious as well as acceptable and safe during pregnancy. There is evidence to support the efficacy of yoga for depression in the general population, as well as plausible biological and psychological mechanisms (e.g., decreased inflammation, increased non-judgment of internal experiences) by which yoga might have an impact on depression. Moreover, prenatal yoga has been associated with health benefits in non- depressed pregnant women (decreased pain, more optimal pregnancy outcomes). Yet, to date, no rigorously designed RCTs have examined the efficacy of prenatal yoga for antenatal depression. Our interdisciplinary team was funded by NIH to develop and pilot test the Prenatal Yoga Program (PYP) for depressed pregnant women. We developed an extensive manual and teacher training program and conducted an open pilot trial (N=34), followed by a pilot RCT (N=20), which compared PYP to a perinatal-focused health education program that controlled for time and attention, namely, the Mom & Baby Wellness Workshop (MBWW). Results of our pilot studies provide strong support for the acceptability, feasibility, and preliminary efficacy of PYP. We now propose to conduct a fully-powered RCT in which 178 depressed pregnant women in their 2nd trimester are randomly assigned to either PYP or MBWW for a 9 week intervention period. In addition to testing the efficacy of PYP, this trial will examine change in biological and psychological factors that may mediate the relationship between treatment group and outcome. Methodology employed will include best practices for a RCT of behavioral intervention, including use of detailed manuals for each study condition, methods for documenting instructor fidelity, blinded outcome assessment, and planned intent-to-treat analysis. The specific aims include: (1) comparing PYP to MBWW in terms of level of depression severity from baseline to intervention endpoint (i.e., 9 weeks after randomization); (2) comparing PYP to MBWW on secondary outcomes (self-reported antenatal depression, anxiety, physical functioning, and sleep disturbance; and rates of preterm birth); and (3) testing biological and psychological mechanisms by examining whether lowered inflammation levels and increased non-judgment of internal experiences mediate the association between treatment group and primary outcome. This study would be the first rigorously-designed RCT of prenatal yoga as an intervention for antenatal depression, a highly prevalent and impairing condition with known risks to mother and child.
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