A digital therapeutic (DTx) designed to help women cope with mood disturbances after giving birth has been shown to be effective in a randomised clinical trial, according to its developer.
Curio Digital Therapeutics said the SuMMER trial of MamaLift Plus – a mobile-based programme that provides self-help tools, educational content, and sleep, mood, and activity trackers – was significantly more effective at treating postpartum depression compared to a sham mobile app.
All the women in the 141-subject study had a confirmed diagnosis of moderate postpartum depression prior to enrolment, i.e. a score above 13, but not exceeding 19, on the widely used Edinburgh Postnatal Depression Scale (EPDS) scale, and used MamaLift Plus or the placebo app for eight weeks.
The SuMMER trial met its primary endpoint, with a four-point or greater improvement in the EPDS score seen in 83% of the treatment group compared to only 22% of the control arm, which was a statistically significant difference.
A secondary endpoint looked at the proportion of patients achieving a 13-point or greater improvement, taking them out of the moderate depression category, and that was achieved in 82% of the MamaLift Plus group versus 30% using the sham software.
As many as 75% of women experience mood disturbances after delivering a baby, and up to 15% of them will go on to develop postpartum depression.
Antenatal depression is also quite common, affecting around 10% of pregnancies, and MamaLift Plus is designed to support expectant mothers who wish to manage symptoms of depression and anxiety during pregnancy or after delivery.
“The positive results from the SuMMER trial underscore the efficacy of MamaLift Plus to address postpartum depression and improve the lives of women experiencing perinatal mood disturbances,” said Professor Stan Kachnowski, the principal investigator of the trial and chair of HITLAB, which specialises in testing digital interventions.
“Our collaboration exemplifies HITLAB’s commitment to advancing women’s healthcare innovations, and we look forward to continuing to drive positive change in the field of digital therapeutics and mental health through rapid evidence generation,” he added.
Curio has developed a range of women’s health DTx, including FertiCalm and FertiLift to support people trying to start a family and BellaLift, a wellness app that uses guided interventions, live coaching, and online consultations to help women reach healthcare goals.
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