Establishment and Maintenance of a Digital Therapeutic Alliance in People Living With Negative Symptoms of Schizophrenia: Two Exploratory Single-Arm Studies
Bibliographic record
Abstract
BACKGROUND: Evidence-based digital therapeutics represent a new treatment modality in mental health, potentially providing cost-efficient, accessible means of augmenting existing treatments for chronic mental illnesses. CT-155/BI 3972080 is a prescription digital therapeutic under development as an adjunct to standard of care treatments for patients 18 years of age and older 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 patients and health care providers is linked with improved clinical outcomes in mental health. Likewise, establishing a similar therapeutic alliance with a digital therapeutic (ie, digital working alliance [DWA]) may be important for engagement and treatment effectiveness of this modality. OBJECTIVE: This study aimed 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-C-001 and study 2: CT-155-C-002) enrolled adults with schizophrenia and ENS receiving stable antipsychotic medication (≥12 weeks). 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 4-week phase. Digital literacy at baseline was evaluated 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 studies 1 and 2, respectively. Most were male (study 1: 71%, 35/49; study 2: 80%, 40/50). The baseline digital literacy assessed through MDPQ score was comparable in both studies (study 1: mean 30.56, SD 8.06; study 2: mean 28.69, SD 8.31) indicating proficiency in mobile device use. After 3 weeks, mARM scores (study 1: mean 5.16, SD 0.8; study 2: mean 5.36, SD 1.06) indicated that a positive DWA was established in both studies. In study 2, the positive DWA established at week 3 was maintained at week 7 (mARM: mean 5.48, SD 0.97). There were no adverse events (AEs) in study 1, and 3 nonserious and nontreatment-related AEs in study 2. CONCLUSIONS: A positive DWA was established between participants and CT-155 beta within 3 weeks. The second 7-week study 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 prescription digital therapeutic under development to target these symptoms. TRIAL REGISTRATION: Clinicaltrials.gov NCT05486312; https://clinicaltrials.gov/study/NCT05486312.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.011 | 0.013 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.005 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.002 | 0.003 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".