Pilot Study of the bWell Cognitive Care Platform for Adults with Major Depressive Disorder Evaluating Feasibility and Effects of VR Cognitive Remediation Over Eight Weeks

What this Trial Is About

This research aims to evaluate the bWell Cognitive Care Platform for Depression bWell-D, a virtual reality VR tool for cognitive assessment and remediation in adults with Major Depressive Disorder MDD. The study focuses on whether patients find the cognitive testing and 8-week remediation program feasible, tolerable, and acceptable. The study includes both depressed patients and healthy volunteers for comparison. Participants diagnosed with MDD, who are currently euthymic or mildly depressed, will first complete a virtual cognitive assessment including rating scales and neuropsychological tests. They will then be randomly assigned to either an active bWell cognitive remediation group, involving twice-weekly 40-minute sessions with progressively challenging cognitive tasks over 8 weeks, or a control group experiencing passive VR scenes on the same schedule. Outcome assessors will be blinded to group assignments. Throughout the study, participants will complete clinical, cognitive, and functional assessments at baseline, midpoint, and end of the 8-week intervention, along with EEG recordings and two MRI scans. Measures of tolerability, engagement, and enjoyment will also be collected. Participants may opt for additional neurophysiology testing. Healthy volunteers will undergo a single assessment session for comparison. The total study period includes screening, intervention, and follow-up assessments lasting approximately 8 weeks.

bWell-D Pilot Randomized Controlled Trial