Testing adaptive interventions to improve PTSD treatment outcomes in Federally Qualified Health Centers: Protocol for a randomized clinical trial.

Sripada RK, Smith K, Walters HM, Ganoczy D, Kim HM, Grau PP, Nahum-Shani I, Possemato K, Kuhn E, Zivin K, Pfeiffer PN, Bohnert KM, Cigrang JA, Avallone KM, Rauch SAM. Testing adaptive interventions to improve PTSD treatment outcomes in Federally Qualified Health Centers: Protocol for a randomized clinical trial. Contemporary clinical trials. 2023 Jun 1; 129:107182.

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Abstract:

BACKGROUND: Posttraumatic stress disorder (PTSD) disproportionately affects low-income individuals and is untreated in 70% of those affected. One third of low-income Americans are treated in Federally Qualified Health Centers (FQHCs), which do not have the capacity to provide all patients with first-line treatments such as Prolonged Exposure (PE). To address this problem, FQHCs could use low-intensity interventions (e.g., Clinician-Supported PTSD Coach: CS PTSD Coach) and medium-intensity interventions (e.g., PE for Primary Care: PE-PC) to treat PTSD with fewer resources. However, some patients will still require high-intensity treatments (e.g., full-length PE) for sustained clinical benefit. Thus, there is a critical need to develop stepped-care models for PTSD in FQHCs. METHOD: We are conducting a Sequential, Multiple Assignment, Randomized Trial (SMART) with 430 adults with PTSD in FQHCs. Participants are initially randomized to CS PTSD Coach or PE-PC. After four sessions, early responders step down to lower frequency interaction within their assigned initial treatment strategy. Slow responders are re-randomized to either continue their initial treatment strategy or step up to Full PE for an additional eight weeks. The specific aims are to test the effectiveness of initiating treatment with PE-PC versus CS PTSD Coach in reducing PTSD symptoms and to test the effectiveness of second-stage strategies (continue versus step-up to Full PE) for slow responders. CONCLUSIONS: This project will provide critical evidence to inform the development of an effective stepped-care model for PTSD. Testing scalable, sustainable sequences of PTSD treatments delivered in low-resource community health centers will improve clinical practice for PTSD.