Costs and clinical outcomes of digital health navigators supporting engagement with prescription digital therapeutics in mental health: feasibility study

Abstract Background Despite growing availability of Germany's Digital Health Applications (DiGA), uptake and sustained engagement remain limited. Barriers include low digital literacy, limited clinician familiarity, and challenges integrating digital tools into clinical workflows. Digital Health Navigators (DHNs) have been proposed to address these barriers, yet little is known about the relationship between DHN-related resource use and clinical outcomes. This study examined this association in routine outpatient care. Methods This multicenter feasibility study included adult patients from three psychiatric outpatient clinics and three general practices in Brandenburg, Germany. Participants were prescribed one of 29 approved mental health DiGAs and supported by DHNs over three months. Intervention costs were based on the number of DHN contacts, personnel costs, and DiGA reimbursement. Outcomes included changes in symptom severity, psychosocial functioning, and DiGA engagement. Associations between costs and outcomes were examined using age- and baseline-adjusted linear regression models. Results 42 participants completed the intervention and were included in the analyses (mean age 43.0 years; 59.5% female). Participants received a mean of 12.9 DHN check-ins. Mean costs per patient were €102.6 (SD 70.1) for DHN support and €229.3 (SD 8.0) for the DiGA. Clinical outcomes improved, with mean GAF scores increasing from 56.5 (SD 15.9) to 64.9 (SD 18.2) and mean CGI scores decreasing from 4.0 (SD 1.2) to 3.2 (SD 1.4). Self-reported engagement fell between occasional and regular use, with typical sessions of 15 to 30 minutes. Higher intervention costs were consistently associated with greater improvements in psychosocial functioning (β = 0.08, 95% CI 0.03 to 0.12) and symptom severity (β = −0.01, 95% CI − 0.02 to − 0.003). These associations persisted in sensitivity analyses excluding DiGA costs, indicating a robust relationship between DHN support intensity and clinical improvement. Conclusions DHN-supported use of DiGAs is associated with improved clinical outcomes in routine care. The observed cost–outcome relationship may reflect differences in DHN support intensity and highlights the potential role of DHNs in implementation. Further studies should assess cost-effectiveness and integration into health systems. Trial registration: German Clinical Trial Register: DRKS00034327; https://drks.de/search/en/trial/DRKS00034327; Date of registration in DRKS: 2024-08-14; ClinicalTrials.gov: NCT06575582; https://clinicaltrials.gov/study/NCT06575582; Registration Date: 2024-09-03; International Registered Report Identifier (IRRID): DERR1-10.2196/67655