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Funded Research

Determining What is Right for Whom: A Hybrid Experimental Clinical Trial of Tailored Intervention Sequencing to Maximize Effectiveness of PTSD Treatment

Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) are the first-line, most effective treatments for posttraumatic stress disorder (PTSD), but up to 41% of patients complete treatment without clinically significant improvement. When there are early indications of non-response or patients are not completing essential between-session homework, it remains unknown how to effectively adapt and sequence intervention strategies to course correct and maximize effectiveness. Given this uncertainty, there is an urgent need to determine how to treat PTSD more effectively and efficiently, leveraging both therapist-delivered and digital strategies. To optimize the integration of therapist strategies with daily digital prompts, our team developed a novel experimental approachthe Hybrid Experimental Design (HED). The HED enables randomization to a series of therapist-delivered and digital intervention strategies to determine what works best for whom and under what conditions. This design will result in an empirically derived adaptive treatment regimen that maximizes effectiveness with parsimony of resources. First, participants (N = 302) will be randomly assigned to CPT or PE. Following 6 sessions, participants will be categorized as early responders (= 15-point reduction on the PTSD Checklist) or early non-responders. Early non-responders will be re-randomized to one of two rescue strategies: either 1) change to a more flexible, modular version of the same treatment (MODULAR) or 2) switch to the alternate treatment (SWITCH). Early responders will be randomized to one of two maintenance strategies: 1) continue in the same treatment (CONTINUE) or step down to self-managed care (STEP DOWN). Additionally, participants will be randomized daily to receive or not receive a digital prompt encouraging them to complete the daily between-session homework.

Funding:

The University of Texas Health Science Center at San Antonio

Funding Period:

08/15/2024 to 08/14/2025