JMIR Publications

ABSTRACT

Background:

Evidence-based digital therapeutics represent a new treatment modality in mental health that may provide cost-efficient and accessible means of augmenting existing treatments for chronic mental illnesses. CT-155/BI 3972080 is a prescription digital therapeutic (PDT) under development with intended use as an adjunct to standard of care treatments for adults with experiential negative symptoms (ENS) of schizophrenia. Individual components of CT-155/BI 3972080 are designed based on the underlying principles of face-to-face treatment. A positive therapeutic alliance between the patient and healthcare provider has been linked with improved clinical outcomes in mental health. Likewise, establishing a similar therapeutic alliance with a digital therapeutic (i.e., a digital working alliance, DWA) may be important for engagement and treatment effectiveness of this modality.

Objective:

To investigate the establishment and maintenance of a DWA between a beta version of CT-155/BI 3972080 (CT-155 beta) and adults with ENS of schizophrenia.

Methods:

Two multicenter, exploratory, single-arm studies (Study 1: CT-155-C001, Study 2: CT-155-C002) enrolled adults with schizophrenia and ENS receiving stable antipsychotic medication (≥12 weeks). In both studies, participants had access to CT-155 beta and were presented with daily in-app activities during a 3-week orientation phase that included lessons designed to facilitate building of a DWA. In Study 2, the 3-week orientation phase was followed by an abbreviated active phase of 4 weeks. Digital literacy at baseline was evaluated in both studies using the Mobile Device Proficiency Questionnaire (MDPQ). The mobile Agnew Relationship Measure (mARM) was used to assess DWA establishment after 3 weeks in both studies, and after 7 weeks in Study 2 to assess DWA maintenance. Participant safety, digital literacy, and correlations between negative symptom severity and DWA were assessed in both studies.

Results:

Of the enrolled participants 94% (46/49) and 86% (43/50) completed Study 1 and 2, respectively. Most were male (71% and 80%). The overall baseline MDPQ score was comparable in both studies (mean [SD] Study 1: 30.56 [8.06] and Study 2: 28.69 [8.31]) indicating proficiency in mobile device use. After 3 weeks, mARM scores (Study 1: mean [SD]: 5.16, [0.8] and Study 2: mean [SD]: 5.36 [1.06]) indicated that a positive DWA was established in both studies. Furthermore in Study 2, the positive DWA established at Week 3 was maintained at Week 7 (mARM: 5.48 [0.97]). There were no adverse events (AEs) in Study 1, and 3 non-serious and non-treatment-related AEs in Study 2.

Conclusions:

In two independent, exploratory studies, a positive DWA was established between participants and CT-155 beta within 3 weeks. The second study conducted over 7 weeks showed maintenance of the DWA to the end of the study. Results support the establishment and maintenance of a DWA between adults with ENS of schizophrenia and a beta version of CT-155/BI 3972080, a PDT under development to target these symptoms. Clinical Trial: Study 2: CT-155-C-002/NCT05486312