Title: Therapeutic Misconception and Scientific Reframing

Dates: 7/1/2014 - 6/30/2016

Funder: National Institute of Mental Health

Funding: $460,625

PI: Charles Lidz, Ph.D.

Description: Charles Lidz is the PI on a Therapeutic Misconception (TM) study that will take a major step in the direction of determining how to reduce TM in clinical trials. TM involves patient/subjects failing to grasp the difference between participating in a clinical trial and receiving ordinary clinical care. This study will provide the basis for a transformation of the manner in which clinical researchers gain consent from participants, and substantially reduce one of the major barriers to genuine informed consent to research. This study is designed as a hypothetical randomized trial comparing an enhanced disclosure using scientific reframing designed to reduce TM versus disclosure as usual. The hypothetical study is as close to a real one as possible, including gaining consent in real clinical settings with real patients who would be eligible for the mock protocol that will be very similar to a recently closed protocol. The study involves three different clinical services at a university medical center. This design will test the ability of a scientific reframing disclosure to reduce TM and also test whether such disclosure reduces the inclination of potential subjects to volunteer for a clinical trial.