Adherence and Engagement Metrics With the Novel Prescription Digital Therapeutic, CT-152

Introduction: Based on the results of the pivotal MIRAI trial (NCT04770285), CT-152 received FDA clearance as a prescription digital therapeutic adjunct to antidepressant treatment (ADT) in patients with major depressive disorder (MDD). This post hoc analysis characterized participant adherence and engagement.
Methods: Adults aged 22–64 years with MDD with inadequate response to current ADT 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 ADT. 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&#3f1 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.
Conclusions: In the CT-152 group, adherence was high, and engagement metrics could be utilized to characterize participants’ EFMT performance.