A Pilot Study to Assess if Patients With Schizophrenia Can Form a Working Alliance With a Digital Therapeutic

This work was sponsored by Boehringer Ingelheim and Click Therapeutics Introduction The patient–therapist relationship is key to positive outcomes in psychotherapy. Digital therapeutics with evidence of safety and efficacy in preventing, treating, or managing disease have increased, yet establishing a digital working alliance (DWA) may be necessary for positive outcomes. This study examined whether patients with schizophrenia and experiential negative symptoms (ENS) established effective DWAs with a beta version of a prescription digital therapeutic (CT-155). Methods In this exploratory 3-week single-arm study, DWA was assessed weekly by mobile Agnew Relationship Measure (mARM), while negative symptoms (Clinical Assessment Interview for Negative Symptoms Motivation and Pleasure Scale [CAINS-MAP]) were assessed at baseline. Engagement and lesson completion were measured throughout. Results Of 49 enrolled adults, 46 (94%) completed the study. mARM total and subscale scores showed a positive DWA was established after 1 week of use [mean total score: 5.15, SD: 0.7] and maintained over 3 weeks [mean total score: 5.16, SD: 0.8]. mARM scores correlated positively with overall engagement (sessions completed; r2=0.4, p=0.01). No statistically significant relationship was detected between DWA strength (measured by mARM) and ENS (measured by CAINS-MAP). Participants completed a median of 15 from 18 core lessons. There was no relationship between CAINS-MAP and lesson completion. Conclusions Patients experiencing or diagnosed with ENS established and maintained an effective DWA with a beta version of CT-155 that positively correlated with session completion, and was not significantly impacted by ENS severity. Results showcase the potential for prescription digital therapeutics in treating ENS of schizophrenia. Funding: Boehringer Ingelheim and Click Therapeutics