Postpartum depression affects about 15% of women after the birth of a child. Current clinical guidelines for the treatment of postpartum depression (PPD) recommend considering psychotherapy, including interpersonal psychotherapy and cognitive behavioral therapy, as first-line treatment for mild to moderate PPD. In addition, for women with more severe symptoms, psychotherapy can add significant benefits alongside antidepressant treatment. However, many postpartum patients do not have access to specialized care for PPD for a variety of reasons, including mental health provider shortages, insurance coverage issues, childcare challenges, and transportation.
It was important enthusiasm about using digital applications to provide psychotherapy and improve access to much-needed care. Curio Digital Therapeutics Inc, a New Jersey-based digital health company, announced FDA approval MamaLift PlusTM, an eight-week prescription digital therapeutic (PDT) for the treatment of postpartum depression (PPD). This is the first digital therapeutic approved for the treatment of PPD. Unlike other digital mental health apps now available, MamaLift Plus can only be used under the supervision of a healthcare provider.
MamaLift Plus offers digital Cognitive Behavioral Therapy (CBT), Behavioral Activation Therapy (BAT), Interpersonal Therapy (IPT) and Dialectical Behavioral Therapy (DBT) for postpartum depression. CBT, BAT, IPT, and DBT are neurobehavioral therapies that focus on addressing the maladaptive behaviors, routines, and dysfunctional thoughts associated with postpartum depression. MamaLift Plus can be used on a mobile device such as a smartphone or tablet.
The MamaLift Plus app was tested on Maternal Mental Health and Emotional Regulation Support or study (Summer)., a national, sham-controlled, randomized controlled trial (RCT). In the SUMMER study, women with mild to moderate PPD (Edinburgh Postnatal Depression Scale scores between 13 and 19). Participants were randomized to the MamaLift Plus intervention or a virtual control (an app that offers information, advice and activities that support overall well-being). Participants were blinded as to their treatment arm. Participants used MamaLift Plus or the sham control every day for eight weeks. Efficacy was measured using the EPDS scale.
In this study, 86.3% (82/95) of participants who received the MamaLift Plus intervention achieved a clinically significant improvement in depressive symptoms on the Edinburgh Postnatal Depression Scale, compared to only 23.9% (11/46 ) of participants in the control group.
What’s next?
MamaLift Plus is a prescription-only digital therapeutic intervention for the treatment of mild to moderate postpartum depression using several different neurobehavioral interventions, including CBT, IPT, DBT, and BAT. Preliminary studies suggest that this intervention, delivered over 8 weeks, is more effective than a sham digital intervention and produces clinically significant reductions in depressive symptoms. (This information was provided in a press release by the company and reviewed by the FDA; it has not yet been published in a peer-reviewed publication.)
Future research will test this intervention in real clinical situations. This is a huge step in increasing treatment care for women with PPD. Right now, when we see a woman with PPD who is interested in psychotherapy, we offer a name, a phone number, or maybe a website. However, we know that the majority of women who are referred for psychotherapy never make it to the first session. As a clinician, imagine making a treatment recommendation that can begin almost immediately. That said, we don’t yet have information on the cost of the intervention, but the company says it will be less expensive than traditional psychotherapy.
We’re also backing the company to make this a prescription-only digital intervention. On the one hand, this decision reduces access, since it must first be recommended by a healthcare provider. On the other hand, this offers some very important security and oversight features. It helps ensure that the app is used in the population it was designed for — women with mild to moderate PPD. Women with more severe depressive symptoms may need other types of interventions, including family support, medication, or hospitalization. One would also hope that providers receive feedback on their patients’ progress and are notified if the app is not being used or if symptoms worsen.
Ruta Nonacs, MD PhD
To learn more about MamaLift Plus and sign up for updates, click here.
