Preventing Maternal Mood, Anxiety, and Trauma Symptoms after Cesarean Delivery

PROJECT SUMMARY Perinatal mental health disorders are the most prevalent perinatal comorbidity and are associated with the primary cause of maternal mortality in the United States (US) – suicide. Diagnosis of a high-risk pregnancy and cesarean delivery (CD) are both associated with increased risk for perinatal mood, anxiety, and trauma

symptoms (PMATS). There are over 1 million CDs annually in the US with one-third of these patients reporting PMATS. Directing prevention efforts toward high-risk pregnant patients requiring CD addresses risk for PMATS in a large patient population. There is a deficit in resources and access to mental health treatment for pregnant

patients, with some treatments being cost prohibitive and requiring multiple sessions. Additionally, current approaches to addressing PMATS are reactive rather than preventive. There is evidence in the non-obstetric population that single-session cognitive behavioral therapy interventions targeting anxiety sensitivity (fear of

fear) can prevent the development of anxiety and trauma symptoms when individuals are exposed to a trauma. We developed a low cost, 1-hour, single-session prevention intervention that included psychoeducation about anxiety sensitivity, coupled with a brief exposure to the operating room environment and CD procedures. We

previously tested this Brief Exposure intervention in the Operating Room (BE-OR) among a small group of pregnant patients anticipating CD at a fetal care center and found a significant reduction in PMATS in the short (1-4 weeks) and the long term (6-8 weeks). These results are incredibly promising, but scalability to a large

labor and delivery (L&D) unit with a more diverse patient population has not been established. To revise implementation plan and BE-OR for use in large L&D units with a broader population of patients, a fully powered multisite randomized control trial (RCT) is needed. Prior to initiating such a trial, Stage 1A/1B work

needs to be done to modify the intervention and implementation through a process of iterative refinement to enhance acceptability, appropriateness, and feasibility of implementation in L&D units across the country, as well as its efficacy at engaging with the target mechanism (anxiety sensitivity). Using a logic model to guide the

iterative refinement process through fast feedback loops and an atmosphere of co-creation, study investigators will gather critical input from stakeholders (individuals with lived experiences, community partners, front-line clinicians, hospital staff) via 12 workgroups, 12 user-testing design sessions, and repeated engagement with a

steering council. Following this refinement process, a treatment development pilot RCT (N=80) at a large L&D unit will assess the efficacy of BE-OR by probing engagement with the target mechanism, as well as assess feasibility of implementation. Finally, the updated logic model and pilot trial results will inform the development

of a protocol for a multisite RCT through engagement with expert consultants in a community engagement studio and further feedback from the steering council. This study will be the first in a long line of research broadening to additional risk groups, perinatal care settings, and intervention modalities to reduce PMATS.