Establishment of a Digital Therapeutic Alliance in Participants Living with Negative Symptoms of Schizophrenia
Introduction: Patient-digital therapeutic (DTx) bonds (digital working alliance [DWA]) may be important for DTx success.
Aims: To assess whether a DWA could be established between participants with experiential negative symptoms (ENS) of schizophrenia and CT-155/BI 3972080 (CT-155 beta), a prescription DTx under development for the treatment of ENS.
Methods: Two exploratory, single-arm, multi-center studies (Study 1: 3-weeks, Study 2: 7-weeks) 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: Participants with schizophrenia and ENS reported establishment of a DWA with a DTx, which was unaffected by age, race, or ENS severity.
Funding: Boehringer Ingelheim Pharmaceuticals, Inc.
