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| Name | Class |
|---|---|
| Curio Digital Therapeutics, Inc. | INDUSTRY |
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Primary Objective: Evaluate the clinical effectiveness of the MamaLift Plus app compared to control (digital sham plus treatment as usual) for the management of PPD in the observed population for a period of 9 calendar weeks. It is hypothesized that women who use the MamaLift Plus APP will experience less severe symptoms of depression in post-partum period than comparable women who do not and receive their usual care from health providers.
Women between 18 and 50 years of age who have had a live birth within 3 months prior to study start date and have a diagnosis of mild to moderate PPD. A total of 200 women will be recruited to volunteer in the study with 166 assigned to the intervention arm and 37 assigned to the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MamaLift Plus | Experimental | Principles of Cognitive Behavioral Therapy used to treat PPD with App |
|
| Digital Sham App | Sham Comparator | Content on general mental health and wellbeing topics delivered with sham App |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MamaLift Plus | Device | MamaLift Plus is a digital therapeutic designed to augment usual care and support the treatment of mild-to-moderate postpartum depression (PPD). This mobile-based intervention is grounded on principles of Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT) and includes key content areas for the treatment management of PPD. It also includes recent developments in acceptance and commitment-based therapies, specifically for the perinatal context. |
| Measure | Description | Time Frame |
|---|---|---|
| EPDS Score | Proportion of women that improve EPDS by >= 4 points at their end of study assessment. | 9 week period |
| EPDS Score improvement | Proportion of women that improve EPDS to < 13 points at their end of study assessment | 9 week period |
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Inclusion Criteria:
Exclusion Criteria:
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Adult females who delivered live births in the 3 months prior to study start
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| Name | Affiliation | Role |
|---|---|---|
| Stan Kachnowski, PhD | Healthcare Innovation Technology Lab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthcare Innovation and Technology Lab | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40549508 | Derived | Dixit S, Malladi I, Shankar S, Shah A. Evaluating the Efficacy of MamaLift Plus Digital Therapeutic Mobile App for Postpartum Depression (SuMMER): Randomized, Placebo-Controlled Pivotal Trial. J Med Internet Res. 2025 Jul 1;27:e69050. doi: 10.2196/69050. |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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The data of 200 participants will be collected and analyzed for this study. Participants will be selected from a pool of patients who have given birth in the last three months prior to the study start date and been diagnosed with postpartum depression or have experienced depressive symptoms. The study aims to recruit a diverse study cohort across age, race, and SES to reflect the intended user population in the United States.
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Participants are not aware of whether they are receiving the MamaLift Plus interventional device or the digital placebo device. The applications have the same user interface and require a similar amount of time to complete activities. Participants in both arms will receive treatment as usual in addition.
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| Digital Sham App | Device | The digital sham app delivers content, tips, and suggestion for general wellbeing support. |
|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |