A new clinical trial at Virginia Commonwealth University aims to study the impact of mindfulness activities and social connectedness on people who are experiencing depression while pregnant. If effective, the low-cost intervention could be replicated in other communities.
Funded in May by a nearly $2.4 million, five-year grant from the National Institutes of Health and National Institute of Nursing Research, this study will offer weekly activities to pregnant individuals in the Richmond area.
The study’s co-principal investigator, Patricia Kinser, Ph.D., an endowed professor in the VCU School of Nursing and co-director of perinatal mental health research at the VCU Institute for Women’s Health, said this research is important because although treatments exist for depressive symptoms, many people who experience depression while pregnant remain under- or untreated due to concerns about stigma, side effects and cost of medications or psychotherapy.
While postpartum depression is the focus of many conversations surrounding pregnancy and depression, she said, nearly 20% of women in the United States experience clinically significant depressive symptoms during pregnancy.
“The idea here is to provide an intervention that’s low cost, easily accessible, that engages people and empowers them to manage their symptoms. It doesn’t depend upon a prescription; it doesn’t depend upon a provider being accessible to them. This is something that they can learn and then use it in their life,” Kinser said. “Focusing on adequate depressive symptom management through accessible therapies is an urgent clinical and research priority.”
The study will include 12 weeks of 75-minute sessions offered to pregnant people in their second trimester. As part of the randomized controlled trial, all participants will engage in motivational interviewing with study staff to help identify strengths and interests in maintaining their own health and wellness. Then participants will be randomly assigned either to a control group — receiving prenatal education — or to a group taking part in the Mindful Moms program. The Mindful Moms program includes sessions focused on mindfulness techniques through a yoga-based approach.
At the end of the study, researchers will conduct a blood draw to measure whether and how participants’ physical or psychological environment is affecting DNA methylation, which modulates the expression of one’s genes. Kinser said measuring low-cost, non-medication interventions like this to find one that works for those who are experiencing depression while pregnant has the potential to help them and, in turn, their children, in preventing adverse outcomes from early childhood exposure to unmanaged or untreated depression.
Both study groups will aim to provide social connectedness for participants. Co-principal investigator Susan Bodnar-Deren, Ph.D., an associate professor in the Department of Sociology in VCU’s College of Humanities and Sciences and co-director of perinatal mental health research at the VCU Institute for Women’s Health, said the team is hopeful that their work will enhance social connectedness for participants in the groups and outside the immediate network of the study as well.
“We know that social connectedness and social support are protective, not only for emotional health and well-being, but for physical health and well-being,” Bodnar-Deren said. “It’s a very practical, low-cost intervention that has the potential to carry on in the participants’ lives.”
The team is partnering with community organizations across the Richmond area to meet participants where they are. One such organization is Healthy Hearts Plus II, led by Alice Freeman, which has provided invaluable insights to the team regarding reaching individuals in the community and how to address participants’ concerns about being in a research study during a pandemic.
Reaching participants in Richmond, including those living in public housing, is one of the team’s goals because the researchers want to offer future mothers in these areas access to self-management and self-care tools that might not be as readily available to them as to those in other areas of the city.
“We’ve taken an intersectionality framework that, when we look at under-resourced moms, we’re not looking at them in just one category, but that your minoritized status matters, your socioeconomic status matters, your educational attainment matters, and often those work together for cumulative advantage or cumulative disadvantage,” Bodnar-Deren said.
If the results of the study support it, Bodnar-Deren and Kinser said the model could be replicated in other areas. In the short-term, though, they hope to see changes at the individual level.
“Because we’re interested in interventions that can reduce and mitigate depression, the most immediate outcome that we hope is decreased depressive symptoms and any other associated symptoms, stress, anxiety, etc.,” said Kinser.
And, Bodnar-Deren said, the research has the potential to translate to these mothers’ lives long past the duration of the study.
“The practice of mindfulness and yoga is a tool that you can take with you into your future, so it’s not just contained within the 12-week intervention period. But it has this beautiful portability, it’s free and it allows you to have a practice that’s going to help you not just in terms of the regulation of stress and distress around the perinatal period, but for the rest of your life,” Bodnar-Deren said.
The latest study is one of several projects focused on social connectedness underway at VCU. Teams across VCU are addressing social connectedness among older, low-income adults in projects funded within the past few years as well.
“This particular call from NIH was asking us to look at how social connectedness plays a role in interventions for depression, and this is a concept that also hasn’t had a lot of attention, especially in the broader science world of how you look at how the quality and quantity of social relationships can play a role in your mental health,” Kinser said. “This is an opportunity to delve deeply into that with regards to depression in this particular population.”
Kinser developed Mindful Moms as part of a pilot study in 2016 that was funded by the National Institutes of Health and National Institute of Child Health and Human Development. In addition to the current study of people who are experiencing depression while pregnant, Kinser is also leading a study of a mobile-based intervention for pregnant people experiencing symptoms of depression.
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