. Prenatal Maternal Stress (PNMS) is commonly defined as the combination of stressful life-events, elevated perceived stress, pregnancy-specific stress, and symptoms of depression and anxiety. It is a well-established risk factor for preterm delivery and low birth-weight, both of which are leading causes of infant mortality, mor- bidity and chronic health problems. It is also one of the most robust predictors of postpartum maternal mental health problems. Despite this, PNMS often remains untreated due to inadequate screening, concerns about medication safety, stigma, practical barriers accessing care, and a lack of evidence based interventions. Thus, there is a critical need for the development of comprehensive interventions for PNMS that are accessible to women during pregnancy. The long-term goal of this K 23 proposal is to build a program of research focused on methods for treating PNMS that have demonstrable mental and physical health benefits for woman and children. The overall objective of this application is to evaluate the feasibility (primary aim), acceptability and preliminary efficacy (secondary aims) of the SMART-Pregnancy Program a multimodal CBT-based mind-body intervention for PNMS delivered via videoconferencing. Behavioral intervention technologies such as videocon- ferencing can minimize practical barriers to accessing care.
The specific aims are: Phase 1 Program Devel- opment:
Aim 1 : We will identify treatment needs and preferences, barriers to treatment engagement and ap- propriate countermeasures using a focus group approach (N = 6 groups, 6-8 per group). Data will be synthe- sized and used to develop the online SMART-Pregnancy Program.
Aim 2 : We will refine and finalized treat- ment modifications by conducting an open pilot of the SMART-Pregnancy protocol via online videoconferenc- ing (N = 8). Exit interviews will be used to assess accessibility, goodness of fit to needs, and barriers to en- gagement and adherence. Phase 2: Program Feasibility:
Aim 1 (primary): We will examine the feasibility of conducting an RCT in which women with elevated PNMS are randomized to an online SMART-Pregnancy group (n=30) or treatment as usual (TAU; n=30). We will evaluate rates of eligibility, enrollment, and retention. We predict > 75% retention through all 3 study follow-ups.
Aim 2 (secondary): We will collect data on treat- ment adherence (# of sessions attended) and preliminary efficacy. We predict that SMART-Pregnancy partici- pants will attend >75% of online sessions and will display greater reductions in distress and improvements in stress regulation at post-treatment than TAU. We will also explore treatment impact on maternal health and delivery outcomes. Career development goals include: developing expertise in perinatal stress and mental health, learning mixed-methods techniques for optimizing interventions, and gaining experience in the assess- ment of perinatal health and birth outcomes. A multidisciplinary team of leading experts in perinatal stress (Marci Lobel PhD), perinatology (David Garry DO, MFM), mind-body medicine, and mixed-methods (Elyse R. Park PhD, MPH), and grantsmanship/RCT implementation (Adam Gonzalez PhD) will provide mentorship.
. The current proposal will use a 2-phase mixed methods approach to evaluate the feasibility (primary aim), acceptability and preliminary efficacy (secondary aims) of the SMART-pregnancy program, a CBT mind-body program aimed at mitigating the mental and physical health effects of prenatal maternal stress (PNMS). This will be the first randomized clinical trial to evaluate a group based mind-body program for PNMS delivered via videoconferencing. This K23 patient oriented training grant will lay the groundwork for an R01 aimed at testing the efficacy of SMART-pregnancy for women with elevated PNMS via a full-scale RCT, and ultimately, an independent program of research focused on the development and dissemination of behavioral health interventions aimed at improving the health of women and children.
