Evaluating evidence based options for initial PTSD treatment non-response: A randomized controlled trial protocol

Posttraumatic stress disorder (PTSD) affects approximately 23% of veterans and 8% of U.S. adults, and it is associated with negative physical and mental health outcomes, decreased quality of life, substantial impairments in functioning, and increased suicide risk. Research has demonstrated that 14-50% of those receiving evidence-based PTSD treatments retain significant PTSD symptoms and/or continue to meet criteria for PTSD. Yet, there is currently no empirically-based guidance for optimal subsequent treatment options for these individuals. This lack of empirical guidance leaves individuals and their providers guessing about next steps, possibly prolonging treatment, and increasing feelings of defeat as the number of ineffective courses of care mount. This study will address this gap by examining 1) the feasibility of offering a subsequent course of evidence-based psychotherapy for individuals who continue to meet criteria for probable PTSD (PCL-5 severity ≥28) following an initial course of a Cognitive Processing Therapy and 2) the efficacy of different subsequent psychotherapy-based treatment options for initial non-responders. Moreover, the study will help move toward personalizing treatment by 3) examining potential moderators/predictors of subsequent treatment response, and 4) developing an algorithm to identify likely non-responders prior to completion of an initial treatment course, allowing them to enroll in another potentially effective treatment sooner. Findings from this study will help advance personalized medicine approaches for PTSD treatment by evaluating subsequent treatment options for initial non-responders and identifying individual characteristics that may predict a stronger fit for one subsequent treatment option over another.

ClinicalTrials.gov Identifier: NCT06733376.