Shrinking the know–do gap in psychedelic-assisted therapy

This recent article in Nature Human Behaviour states: "There is a push to shrink the anticipated 17-year research-to-practice gap for psychedelic-assisted therapy (PAT), offering precarious hope to those with disabling mental health conditions. However, numerous questions regarding how PAT works, how well it works, for whom and in what context remain. Substantial changes to current systems of care, including regulatory approvals, clinical training and access will all be required to accommodate PAT, a multimodal therapy that combines pharmacological and psychotherapy components that are not routinely available outside clinical research settings. Implementation science can help to reduce the gap in a way that maintains scientific rigour by simultaneously examining the safety, effectiveness and implementation of PAT. Specifically, precision implementation science methods (for example, sequential multiple assignment randomized trial (SMART) designs), hybrid study designs, valid measurement of fidelity and use of theory-based models and frameworks for treatment development will accelerate the process of implementation while balancing safety and quality. The time to proceed, with accelerated caution, is now. [The Microdose … https://tinyurl.com/n4crcy2x … comments: While many clinicians and patients are excited about the potential of psychedelic treatments, the transition from research labs to therapists’ offices will take years. “Historically, it takes 15-17 years to move a non-pharmaceutical treatment innovation from research into routine clinical practice,” Washington University and University of Missouri researchers write in a new paper published in Nature Human Behavior on Monday. But an area of study called implementation science might help what the researchers call the “know-do gap.” The authors write that implementation of psychedelic-assisted therapy could be sped up if clinicians and researchers worked together more closely before final approval by the Food and Drug Administration to solve issues like licensure and training requirements. That process could also be hastened by evaluating implementation strategies alongside research, the authors write. Though such strategies typically aren’t tested until after a treatment is approved, the researchers say that testing treatments and strategies for real-life implementation simultaneously can provide much-needed insight into not only whether such treatments work, but also how they should be rolled out at a larger scale to patients. The authors give the example of clinical studies that provide a private room for patients to lie down for 8 hours after receiving a psychedelic dose. “This infrastructure does not exist in the resource-constrained systems where community mental healthcare is currently delivered,” they write, and testing how variation in set and setting affects treatment “should be intentionally incorporated into treatment protocols so that its effect on treatment outcome can be quantified.”].

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