Abstract
BACKGROUND: Improvement in the Edinburgh Postnatal Depression Scale (EPDS) score is a regulatory-approved measure for symptom improvement in postpartum depression (PPD). While digital solutions have the potential to overcome common treatment barriers, few have shown clinically significant improvement in PPD symptoms, as measured by the EPDS. OBJECTIVE: This study aimed to evaluate the clinical efficacy of the MamaLift Plus digital therapeutic for the improvement of PPD symptoms in women who had recently given birth and had PPD, as assessed by the EPDS. METHODS: This double-blind, randomized, placebo-controlled phase 3 pivotal trial recruited participants remotely. Eligibility criteria required that participants have an EPDS score between 13 and 19 and a confirmed diagnosis of PPD. Participants were randomized to the MamaLift Plus intervention or sham control arm, with stratification based on new mom status. "New moms" are those who have had one live birth. MamaLift Plus is a self-guided 8-week digital therapeutic for symptomatic treatment for PPD. MamaLift Plus can be used on a mobile device. MamaLift Plus delivers digital Cognitive Behavioral Therapy, Behavioral Activation Therapy, Interpersonal Therapy, and Dialectical Behavior Therapy for PPD. The sham control mimicked the features, functionality, and user experience of the treatment. The most important difference between the 2 arms was that participants in the sham control app did not receive any Cognitive Behavioral Therapy. Primary and secondary endpoints were self-assessed. The primary endpoint was the proportion of participants whose EPDS scores improved by ≥4 points at the end of the study assessment. The intent-to-treat (ITT) analysis set included all randomized participants who started at least 1 module. The full analysis set (FAS) population included all participants who completed at least one postbaseline assessment. The trial is closed. RESULTS: Participants were recruited remotely between April 18 and May 24, 2023. Eligible participants were assessed by a licensed mental health provider to confirm a diagnosis of PPD. In addition, 95 participants were randomized to the intervention and 46 to the control groups. A total of 86.3% (82/95) of MamaLift Plus arm participants achieved an improvement of ≥4 points, compared with 23.9% (11/46) of sham control arm participants (P<.0001). There were 2 adverse events each in the intervention arm 2.1% (2/95) and sham control arm 4.3% (2/46). Only 11 participants failed to provide any postbaseline assessment for the primary endpoint. CONCLUSIONS: Participants who received MamaLift Plus exhibited significant and clinically meaningful improvement in depressive symptoms compared with control. Results suggest MamaLift Plus has the potential to improve treatment outcomes for women experiencing PPD. TRIAL REGISTRATION: ClinicalTrials.gov NCT05958095; https://clinicaltrials.gov/study/NCT05958095.