Study Protocol for a Pilot Randomized Controlled Trial of a Brief, Virtual Exposure-Based Intervention for Perinatal...

Perinatal posttraumatic stress disorder (PPTSD) is a public health concern with serious implications for maternal and infant health outcomes. However, clinical research for PPTSD treatment is minimal. Thus, we aim to help address this gap by evaluating the feasibility, acceptability, and preliminary effectiveness of a tailored PPTSD intervention through a pilot randomized controlled trial (RCT; hereafter referred to as the New Empowerment after Trauma (NEXT) study). The NEXT study also aims to engage those most likely to experience PPTSD and least likely to engage in care, including Black and rural-dwelling perinatal individuals. Enrolled perinatal individuals with PPTSD will be randomized to receive either: 1) perinatal-tailored Narrative Exposure Therapy (NET) (n = 45 completers; treatment group) or 2) enhanced usual care (n = 45 completers; comparator group). This pilot RCT protocol is a critical step towards advancing transparency and reproducibility in perinatal PTSD research, particularly for a population that has been underrepresented in clinical research and warrants further attention. Patient and Public Contributions: Perinatal individuals with PPTSD have shaped the development of this protocol through our preliminary work. Specifically, perinatal individuals with lived experiences of PPTSD contributed to NEXT study materials and the adaptation of the intervention protocol.