Design of a hybrid implementation effectiveness cluster randomized controlled trial of delivering written exposure therapy for PTSD in underserved primary care settings
Lisa S Meredith, Eunice C Wong, Brian P Marx, Bing Han, Ariella R Korn, Jonathan N Tobin, Andrea Cassells, Stephanie Williamson, Meghan Franco, Cleo Clarize Overa, Tameir Holder, T J Lin, Denise M Sloan, Lisa S Meredith, Eunice C Wong, Brian P Marx, Bing Han, Ariella R Korn, Jonathan N Tobin, Andrea Cassells, Stephanie Williamson, Meghan Franco, Cleo Clarize Overa, Tameir Holder, T J Lin, Denise M Sloan
Abstract
Introduction: Posttraumatic stress disorder (PTSD) results in substantial costs to society. Prevalence of PTSD among adults is high, especially among those presenting to primary care settings. Evidence-based psychotherapies (EBPs) for PTSD are available but dissemination and implementation within primary care settings is challenging. Building Experience for Treating Trauma and Enhancing Resilience (BETTER) examines the effectiveness of integrating Written Exposure Therapy (WET) within primary care collaborative care management (CoCM). WET is a brief exposure-based treatment that has the potential to address many challenges of delivering PTSD EBPs within primary care settings.
Methods: The study is a hybrid implementation effectiveness cluster-randomized controlled trial in which 12 Federally Qualified Health Centers (FQHCs) will be randomized to either CoCM plus WET (CoCM+WET) or CoCM only with 60 patients within each FQHC. The primary aim is to evaluate the effectiveness of CoCM+WET to improve PTSD and depression symptom severity. Secondary treatment outcomes are mental and physical health functioning. The second study aim is to examine implementation of WET within FQHCs using FQHC process data and staff interviews pre- and post-intervention. Exploratory aims are to examine potential moderators and mediators of the intervention. Assessments occur at baseline, and 3- and 12-month follow-up.
Conclusion: The study has the potential to impact practice and improve clinical and public health outcomes. By establishing the effectiveness and feasibility of delivering a brief trauma-focused EBP embedded within CoCM in primary care, the study aims to improve PTSD outcomes for underserved patients.
Trial registration: (Clinicaltrials.govNCT05330442).
Keywords: Brief psychotherapy; Collaborative care; Evidence-based psychotherapy (EBP); Federally Qualified Health Centers (FQHCs); PTSD.
Conflict of interest statement
Declaration of competing interest Drs. Sloan and Marx receive royalty payments for the published treatment manual for Written Exposure Therapy. All other authors have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this manuscript.
Copyright © 2024 RAND Corporation. Published by Elsevier Inc. All rights reserved.
Source: PubMed