JMIR Publications

ABSTRACT

Background:

The Supporting Maternal Mental Health and Emotional Regulation (SuMMER) study evaluated the clinical efficacy of the MamaLift Plus digital therapeutic for the improvement of postpartum depression (PPD) symptoms as assessed by the Edinburgh Postnatal Depression Scale (EPDS).

Objective:

The aim of this study was to evaluate the clinical efficacy of MamaLift Plus, a digital therapeutic, in improving postpartum depression (PPD) symptoms.

Methods:

This nationwide, double-blind, randomized, placebo-controlled Ph 3 pivotal trial recruited participants online. Eligibility criteria required that participants have an EPDS score between 13 and 19 and a diagnosis of postpartum depression (PPD) confirmed by a licensed mental health care provider. Participants were randomized to the MamaLift Plus intervention arm or sham control arm and randomization was stratified based on new mom status. MamaLift Plus is a self-guided 8-week digital therapeutic for symptomatic treatment for PPD. MamaLift Plus can be used on a mobile device, such as a smartphone or tablet. MamaLift Plus delivers digital Cognitive Behavioral Therapy (CBT), Behavioral Activation Therapy (BAT), Interpersonal Therapy (IPT), and Dialectical Behavior Therapy (DBT) for PPD. The sham control mimicked the features, functionality, and user experience of the treatment. It was designed to appear and feel like the treatment, but without the therapeutic ingredients that would induce the intended psychological effects. The most important difference between participants in the two arms was that participants in sham control app did not receive any CBT content. Sham control content paralleled the treatment arm with regards to frequency of engaging with the app and the relative “workload” in each arm was similar. 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 Analysis set (ITT) included all randomized participants who started at least 1 module. The Full Analysis Set (FAS) population included all participants who completed at least one post-baseline assessment. The trial is closed (CT.gov identifier: NCT05958095).

Results:

Participants were recruited online between April 18 and May 24, 2023. Eligible participants attended a virtual, face-to-face assessment with a licensed mental health provider to confirm a diagnosis of PPD. 95 participants were randomized to the intervention and 46 to the control. 86.3% (82/95) of MamaLift Plus arm participants achieved an improvement of ≥ 4 points, compared to 23.9% (11/46) of sham control arm participants (p<.0001). There were two adverse events each in the intervention arm (2.1%) (2/95) and sham control arm (4.3%) (2/46). When considering participants with missing data (no post-baseline assessment) at the end of study, only 11 individuals did not provide the primary endpoint assessment.

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. Clinical Trial: ClinicalTrials.gov NCT0595809