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The following is a summary of “A digital therapeutic for people with borderline personality disorder in Germany (EPADIP-BPD): a pragmatic, assessor-blind, parallel-group, randomised controlled trial,” published in the May 2025 issue of Lancet Psychiatry by Assmann et al. 

Researchers conducted a retrospective study to assess the effectiveness and safety of priovi, a digital therapeutic designed for individuals with borderline personality disorder (BPD).  

They implemented a pragmatic, assessor-blind, parallel-group, randomized controlled trial (RCT) in Germany, enrolling individuals aged 18 years or older with BPD of at least moderate severity based on the 23-item Borderline Symptom List (BSL-23), following DSM-5 criteria. Recruitment occurred via online advertisements. Participants consented and had an emergency plan in place for suicidal crises. Using simple computerized coin-toss randomization (1:1) without stratification, participants were allocated to either an unguided schema therapy–based digital therapeutic with treatment as usual (intervention group) or treatment as usual alone (control group). Study investigators remained blinded to group assignments until after the primary outcome analysis. The control group accessed freely available BPD-specific self-help resources. The primary outcome was the time-by-treatment interaction at 3 months, measured by BSL-23 in the intention-to-treat population. Safety was assessed by counting serious adverse events (AEs) (e.g., suicide attempts, hospitalizations, life-threatening events) through an online questionnaire. The digital therapeutic was developed with input from individuals with BPD. The study was registered in the German Clinical Trials Register (DRKS00028888).  

The results showed that between May 3 and Oct 20, 2022, 1,766 individuals were screened, and 580 were randomized, including 302 in the intervention group and 278 in the control group. The cohort included 520 (90%) women, 47 (8%) men, and 13 (2%) gender diverse participants; ethnicity was not documented. At 3 months, 35 (12%) participants in the intervention group and 15 (5%) in the control group discontinued. The median age was 29 years (IQR 24–37). Intention-to-treat analysis using linear mixed models revealed a significant time-by-treatment interaction (P=0.0005) favoring the intervention group (Cohen’s d=0.24 [95% CI 0.07–0.42]). In terms of safety, the intervention group reported fewer suicide attempts (n=7) compared to the control group (n=21), with an incidence rate ratio of 0.34 (95% CI 0.14–0.79; P=0.0081), while no group differences were observed for other serious AEs.  

Investigators concluded that the digital therapeutic priovi demonstrated preliminary effectiveness and did not raise safety concerns in treating individuals with BPD. 

Source: thelancet.com/journals/lanpsy/article/PIIS2215-0366(25)00063-X/fulltext