Evaluating the clinical validity of a real-time cognitive metric derived from AKL-T03, a digital therapeutic targeting attentional control, in the treatment of depression

An advantage of digital therapeutics (DTx) is the ability to provide objective, real-time assessment of patients during cognitivebehavioral treatments, without additional user input beyond engaging with the treatment itself. Randomized controlled trials (RCTs) support the efficacy of AKL-T03, a DTx that targets attentional control via a multitasking treatment game (navigation and targeting tasks), in depression. However, there remains a need to understand how users' treatment data may be used to monitor changes in cognition, which could help with treatment decisions and planning. We aimed to derive and validate a real-time measure of attentional control from AKL-T03 data in depression. We conducted secondary analyses of STARS-MDD (NCT03310281), a 6-week RCT of AKL-T03 versus an active digital control in adults with major depressive disorder. Only the AKL-T03 group (n=37; M age = 43.11; 62% female) was included here. A cognitive metric was derived from targeting response speed, targeting discriminability (d-prime), and navigation ability (80% psychometric threshold), and a Bayesian hierarchical linear-log model estimated patient-level parameters. We regressed changes in the Test of Variables of Attention (TOVA)-Attention Comparison Score (ACS) on changes in the cognitive metric, controlling for TOVA-ACS baseline, cognitive metric baseline, and sex. We explored associations with additional cognitive and clinical outcomes. Most participants showed a consistent logarithmic increase in the cognitive metric over the course of treatment. Increases in the cognitive metric during treatment significantly predicted increases in TOVA-ACS (B = .120, p = .009, Cohen's d = .27). Exploratory analyses indicated that cognitive metric changes were also associated with changes in measures of working memory, visuospatial attention, and processing speed, but unrelated to change in self-reported clinical outcomes. Findings support the validity of a real-time attentional measure from AKL-T03 patient-device interactions. Though limited by a small sample, our study underscores the potential for DTx to provide in-vivo monitoring of cognitive change during treatment.

Duke Scholars

Author Scott Haden Kollins Psychiatry, Child & Family Mental Health & Community Psychia ...