Establishment of a digital therapeutic alliance in patients living with negative symptoms of schizophrenia

Abstract: Introduction: A patient-digital therapeutic (DTx) bond (digital working alliance [DWA]) may be important for DTx success. We assessed whether patients with experiential negative symptoms (ENS) of schizophrenia could establish a DWA with a beta version of CT-155 (CT-155 beta), a prescription DTx under investigation for the treatment of ENS. Methods: Two exploratory, single-arm, multi-center studies (3-week Study 1, 7-week Study 2) evaluated adults with schizophrenia and ENS with access to CT-155 beta. Motivation and Pleasure Scale-Self-Report (MAP-SR) and the Clinical Assessment Interview for Negative Symptoms Motivation and Pleasure Scale (CAINS-MAP) assessed ENS. The mobile Agnew Relationship Measure (mARM) assessed DWA strength. Associations between DWA strength and patient age, ENS severity, and race were investigated. Results: Screening mean (SD) overall MAP-SR score: Study 1, 22.6 (6.8), Nf49; Study 2, 14.9 (8.9), Nf50. Baseline mean (SD) overall CAINS-MAP score: Study 1, 2.37 (0.76); Study 2, 2.28 (0.92). A positive DWA was established and maintained in Study 1 (mean [SD] mARM: 5.15 [0.74], Week 1; 5.16 [0.77], Week 3) and replicated in Study 2 (Week 3, 5.36 [1.06]). mARM scores did not correlate with age (Study 1: ρ=0.31, p=0.054; Study 2: ρ=0.15, p=0.32), screening MAP-SR scores (Study 2: ρ=0.11, p=0.48) or baseline CAINS-MAP scores (Study 1: ρ=-0.16, p=0.36; Study 2: ρ=-0.13, p=0.41) and were unaffected by race (Study 1: F-test=1.193, p=0.719; Study 2: F-test=1.162, p=0.747). Conclusion: Patients with schizophrenia and ENS reported establishment of a DWA with a DTx, which was unaffected by age, race, or ENS severity. Funding: Boehringer Ingelheim/Click Therapeutics.Short Description: The therapeutic alliance between the patient and healthcare professional is critical to successful psychotherapy. In 2 exploratory studies, we investigated if a similar digital working alliance (DWA) between the patients with experiential negative symptoms (ENS) of schizophrenia and a digital therapeutic (DTx) may also be important for CT-155, a prescription DTx in development. Preliminary results demonstrate that patients consistently established a positive DWA with CT-155, which was unaffected by age, race, or ENS severity.Name of Sponsoring Organization(s): Boehringer Ingelheim and Click Therapeutics.