(#36) Engagement, Effectiveness, and Patient Experience of an Investigational Digital Therapeutic for Experiential Negative Symptoms of Schizophrenia: An Exploratory Study

Abstract: Background: CT-155/BI 3972080 is an investigational digital therapeutic for treatment of experiential negative symptoms (ENS) of schizophrenia. Methods: This multicenter, 7-week, single-arm, exploratory study (NCT05486312) included participants aged ?18 years with schizophrenia (?1 year), moderate-to-severe ENS (Motivation and Pleasure-Self Report score ?30) on a stable dose (?12 weeks) of ?2 antipsychotics. Engagement with CT-155 beta (an abbreviated version) was measured passively by the app. ENS severity was assessed by Clinical Assessment Interview for Negative Symptoms Motivation and Pleasure Scale (CAINS-MAP). User experience and acceptability were assessed using a survey and the Mobile App Rating Scale (MARS). Results: 43/50 (86%) enrolled patients completed the study (80% male, 70% non-white, mean [SD] age 48.1 [12.4] years). App engagement during Week 7 was 82% until Day 47. Mean (SD) CAINS-MAP total score decreased from 20.2 (8.6) at baseline to 16.8 (7.8) at Week 7 (t[42]=2.2, p=0.004). Most participants (Week 3: 91% [41/45]; Week 5: 91% [41/45]; Week 7: 84% [37/44]) reported using CT-155 beta at least once a day; the majority (89%ñ95% across Weeks 3ñ7) would recommend it to a friend. Participants rated CT-155 beta as acceptable/good after 7 weeks across engagement (functionality, esthetics, and information quality) domains, with MARS scores ranging from 3.8ñ4.2. Finally, 89% (39/44) agreed/strongly agreed that CT-155 beta was an effective treatment for their ENS. Discussion: Participants engaged with CT-155 beta, indicated that it positively impacted their approach to life, and expressed satisfaction with its functionality and the information it provided. Funding: Boehringer Ingelheim Pharmaceuticals, Inc.Short Description: CT-155 is an investigational digital therapeutic for the treatment of experiential negative symptoms of schizophrenia. This study assessed engagement, potential efficacy, and user experience of an abbreviated version of CT-155/BI 3972080 (CT-155 beta) in adults living with experiential negative symptoms of schizophrenia. Participants engaged with CT-155 beta, indicated that it positively impacted their approach to life, and they highlighted their satisfaction with the functionality and information contained in CT-155 beta.Name of Sponsoring Organization(s): Boehringer Ingelheim Pharmaceuticals, Inc.