CEO and Founder, MD, MS, MPH Curio Digital Therapeutics princeton, New Jersey, United States
Introduction: Postpartum depression, one of the most underdiagnosed obstetric complications, has limited treatment options. This study evaluated the clinical efficacy of MamaLift PlusTM for the improvement of postpartum depression (PPD) symptoms. Methods: Participants (N = 141) with baseline Edinburgh Postnatal Depression Scale (EPDS) scores of 13-19 and diagnosed with PPD were randomized (2:1 ratio) to the MamaLift Plus or sham control app. The MamaLift Plus app delivered Cognitive Behavioral Therapy (CBT), Interpersonal Therapy (IPT), Dialectical Behavioral Therapy (DBT), and Behavioral Activation Therapy (BAT) content while the sham app delivered health content. Sham group paralleled the treatment group in frequency of app engagement and relative “workload.” Results: The primary endpoint was the proportion of women whose EPDS scores improved by ≥4 points at end of treatment (EOT), 8 weeks. The secondary endpoint was the proportion of women whose EPDS score improved to < 13.
Response rates were 86.3% (82/95) in the MamaLift Plus group and 23.9% (11/46) in the sham group (p-value < 0.0001). For the secondary endpoint, the response rates were 83.2% (79/95) and 32.6% (15/46) in the active and control groups respectively (p-value < 0.0001). A subgroup analysis for “new mom” and for “anti-depressive use” was in favor of MamaLift Plus with all corresponding nominal p-values < .001. (Table 1). Conclusion/Implications: These results support the use of MamaLift Plus digital application as a treatment option for all mothers who have mild to moderate PPD. Subgroup results indicate that the beneficial impact of the therapy is consistent regardless of anti-depressive use.
