The PRISM Framework: Integrating Psychological, Regulatory, Behavioral, and Translational Domains in Psychedelic Clinical Trials

Abstract

The psychedelic clinical research field has seen rapid growth in recent years, yet methodological frameworks remain fragmented, often focusing narrowly on pharmacology or subjectove self-report outcomes. The PRISM framework- Psychological Readiness, Regulatory & Ethical Safeguards, In-session Behavior Monitoring, Sense-making & Integration, and Meaningful Behavior Change- offers a translational approach that integrates behavioral science, ethical protocol design, and real-world functional outcomes to enhance safety, data integrity, and therapeutic relevance in psychedelic trials.

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