A novel digital intervention for improving cognitive impairment in patients with chronic schizophrenia: A randomized clinical trial

Background: There is an unmet need for stand-alone digital therapeutics for cognitive impairment in schizophrenia. This study aimed to evaluate the efficacy and acceptability of a novel digital therapeutic, IBT-SC02, for cognitive impairment in stable schizophrenia patients. Methods: A randomized, parallel-group trial was conducted at the Sichuan Province Institute of Mental Health, China. Participants aged 18-50 diagnosed with schizophrenia were randomized to either the IBT-SC02 intervention or a wait-list control. The primary outcome was cognitive performance measured using the MATRICS Consensus Cognitive Battery (MCCB) composite score. Results: A total of 80 patients were randomized (40 intervention, 40 control). The dropout rate was 5 %. The intervention group exhibited significant improvements in the MCCB composite score compared to the control, though the improvement lessened after excluding data collected by unmasked raters. Post-hoc analyses revealed that participants in the intervention group improved in four out of the seven MCCB domains (speed of processing, verbal learning, visual learning and reasoning and problem solving). No adverse events were reported. Conclusions: These results suggest that IBT-SC02, a fully automated digital therapeutic, improved cognitive performance in patients with stable schizophrenia and can potentially be a treatment option for patients without access to trained professionals.