Acute Interventions for Posttraumatic Stress Disorder and Alcohol Misuse in Women Exposed to Sexual Assault: Protocol for a Phased Randomization Trial (Project SARAH)

Background Sexual assault can have devastating consequences for survivors, including posttraumatic stress disorder (PTSD) and alcohol misuse. Interventions provided in the initial months following a sexual assault can prevent the development of chronic problems. Early interventions that are brief, accessible, and focused on shared vulnerabilities may improve efficacy. Objective Project SARAH (Sexual Assault Recovery and Hope) is designed to test fear and reward learning as processes underlying recovery following sexual assault and to elucidate efficacious approaches for brief interventions to address PTSD and alcohol misuse. Methods A phased, doubly randomized, and single-masked clinical trial is being conducted to test the efficacy of acute intervention approaches that target (1) the fear system underlying PTSD with imaginal exposure or (2) the reward system underlying alcohol use with alcohol skills training, comparing these approaches to supportive counseling via telehealth for reducing PTSD and problematic drinking. The interventions are tested in a sample of adult female sexual assault survivors. The phased randomization study design allows for comparisons between imaginal exposure, alcohol skills training, and their combination with the active control, supportive counseling, as well as to test mechanisms of recovery. Results The study was funded in 2019. After modifications to include remote procedures, necessitated by the COVID-19 pandemic, participant enrollment began in March 2021 and ended in December 2025, and our final follow-up was completed in May 2026. We enrolled 82 participants. Analysis of main outcomes (PTSD severity and alcohol use) and dissemination of main outcomes are expected by the summer of 2027. Conclusions This design is significant for exploring PTSD and alcohol recovery pathways acutely following sexual assault.