313. ADHERENCE AND ENGAGEMENT METRICS WITH THE NOVEL PRESCRIPTION DIGITAL THERAPEUTIC, CT-152

Abstract Background Based on the results of the pivotal Mirai trial (NCT04770285), CT-152 received US Food and Drug administration clearance as a prescription digital therapeutic adjunct to antidepressant medication in patients with major depressive disorder (MDD). Aims & Objectives This post hoc analysis characterized participant adherence and engagement in the Mirai trial. Method Adults aged 22–64 years with MDD with inadequate response to current antidepressant medication were enrolled in the Mirai phase 3 trial with a 6-week intervention period and 4-week extension. Delivered via smartphone apps, the CT-152 group received both cognitive-emotional training (Emotional Faces Memory Task [EFMT]) and CBT-based lessons, whereas the control group received a sham app; all continued their current antidepressant medication. The EFMT displayed faces featuring 4 different emotions; participants were asked to recall the emotion displayed N-faces prior (N-back), with progressively higher N-values for successful rounds (beginning at N=1 up to 7). Adequate adherence was defined as completion of ≥12/18 sessions. All statistics were for the CT-152 group and were descriptive, including N-back achievement, time spent per round, and level of adherence. Results In total, 386 participants were randomly assigned to the CT-152 (n=194) or sham (n=192). Overall adherence was high in the CT-152 group. For EFMT, 85% of participants completed ≥12/18 sessions and 40% completed 18/18, and for CBT-based lessons 92% of participants completed ≥12/18 lessons and 72% completed 18/18. Most participants spent 11–26 minutes completing the EFMT, with longer duration as difficulty (N-back value) increased. Discussion & Conclusions In the CT-152 group, adherence was high, and engagement metrics could be utilized to characterize participants’ EFMT performance.