RANDOMIZED CONTROLLED CLINICAL TRIAL OF THE EFFICACY OF THE DIGITAL SELF-HELP PROGRAM EDUPRESSION.COM® IN MILD-TO- MODERATE UNIPOLAR DEPRESSIVE PATIENTS (EFICASY-STUDY)

Abstract Background Recent updates in the S3 and NICE treatment guidelines advocate for the integration of digital health applications into clinical practice. Despite rapid advancements in the digital transformation of depression treatment, clinical adoption remains insufficient, partly due to a lack of robust evidence supporting their efficacy Aims & Objectives The eFICASY study (NCT04839822, DRKS00032121) seeks to strengthen the existing evidence base by assessing the efficacy and healthcare benefits of edupression.com®, a digital self-help program employing cognitive behavioral therapy, medical psychoeducation, and measurement-based care principles. Designed for treating mild to moderate depression, the study also aimed to determine the program's effectiveness as an adjunctive augmentation alongside standard psychopharmacological treatments Method This monocentric RCT with an active control arm spanned 12 weeks, involving 250 adults, aged up to 65, suffering from mild to moderate major depressive episodes. Participants were equally divided into the intervention group (IG) and control group (CG), with allowance for conventional treatments. The IG engaged with edupression.com®, while the CG received medically innocuous content, such as general health tips and relaxation exercises. The study's primary endpoint was the change in depression severity measured by PHQ-9 scores from baseline to end of study (EOS), with secondary endpoints including D-Lit, WHOQOL- BREF, and B-IPQ changes, assessed using a baseline-adjusted linear regression model. Results From 907 initial inquiries, 463 were eligible after interviews, yielding a randomized sample of 250 for ITT analysis. Baseline demographics were comparable between groups. Furthermore, subgroup analysis revealed no significant differences in outcomes whether patients were receiving psychopharmacotherapy or not. The primary analysis showed a greater reduction in PHQ-9 scores in the IG (p<0.001)(see Figure1), with a normalized beta coefficient of 0.26 and Cohen's d of d= 0.58 [95% CI: 0.32 to 0.83]. Notably, 39% of the intervention group (IG) and 18% of the control group (CG) achieved a minimally clinically important difference (MICD) within the ITT sample with an Odds Ratio of 2.8 [CI 1.4 to 5.3]. Per-protocol analysis revealed an increased normalized beta coefficient to 0.35 (p=0.008) and divergent MICD rates (52% IG vs. 16% CG). Secondary analysis found significant benefits in D-Lit for the IG over the CG (p=0.016)(see Figure2), with a normalized beta coefficient of 0.19 and Cohen’ s d of d= 0.36 [95% CI: 0.01 to 0.62] in the ITT sample. Adverse effects were minimal, with 0.8% in the IG and 10.4% in the CG experiencing clinical deterioration. Discussion & Conclusion The eFICASY study demonstrates that edupression.com® significantly reduces depression severity and enhances depression literacy, aligning with S3 and NICE guidelines. These findings highlight the potential of digital interventions as tools in depression management, even as an augmentation to existing psychopharmacological treatments. Future research should focus on long-term impacts and integration strategies to fully harness digital interventions' potential in mental healthcare.