Postpartum depression affects about 15% of women after the birth of a child. Current clinical guidelines for the treatment of postpartum depression (PPD) recommend the consideration of psychotherapy, including interpersonal psychotherapy and cognitive behavioral therapy, as a first-line treatment for mild to moderate PPD. In addition, for women with more severe symptoms, psychotherapy may add important benefits alongside antidepressant medication. However, many postpartum patients are not able to access specialized care for PPD for a number of reasons, including shortages in mental health providers, insurance coverage issues, childcare challenges, and transportation.
There has been considerable excitement regarding the use of digital applications to deliver psychotherapy and to improve access to much-needed care. Curio Digital Therapeutics Inc, a New Jersey-based digital health company, has announced the FDA clearance of MamaLift PlusTM, an eight-week prescription digital therapeutic (PDT) for the treatment of postpartum depression (PPD). This is the first digital therapeutic cleared for the treatment of PPD. In contrast to other digital mental health apps now available, MamaLift Plus can only be used under the supervised care of a healthcare provider.
MamaLift Plus delivers digital Cognitive Behavioral Therapy (CBT), Behavioral Activation Therapy (BAT), Interpersonal Therapy (IPT), and Dialectical Behavior Therapy (DBT) for postpartum depression. CBT, BAT, IPT, and DBT are neurobehavioral treatments 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 in the Supporting Maternal Mental Health and Emotional Regulation or (SuMMER) study, 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 sham control (an app offering information, tips, and activities supporting overall well-being). Participants were blinded to knowledge of 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 receiving the MamaLift Plus intervention achieved a clinically meaningful 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 indicate that this intervention, delivered over a course of 8 weeks, is more effective than a sham digital intervention and yields clinically relevant 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-life clinical situations. This is a huge step in increasing care to treatment for women with PPD. At this time, 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 receive a referral for psychotherapy never make it to the first session. As a clinician, imagine making a treatment recommendation that can be started almost immediately. That said, we do not yet have information regarding the cost of the intervention, but the company indicates that it will be less costly than pursuing traditional psychotherapy.
We also support the company for making this a prescription-only digital intervention. On the one hand, this decision reduces access in that it first must be recommended by a healthcare provider. On the other hand, this offers some very important elements of safety and supervision. It helps to ensure that the app is used in the population for whom it was designed–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 get feedback on how their patients are progressing and are notified if the app is not being used or if the symptoms are worsening.
Ruta Nonacs, MD PhD
To learn more about MamaLift Plus and to sign up for updates, click here.
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