PostPartum Depression
Conditions
Keywords
PostPartum depression (PPD), symptoms of PPD, Anxiety, Peri-natal depression, mild-to-moderate depression
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMamaLift Plus
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.
DEVICEDigital Sham App
The digital sham app delivers content, tips, and suggestion for general wellbeing support.
Sponsors
Curio Digital Therapeutics, Inc.
Healthcare Innovation Technology Lab
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must be able to read, write and speak English; 3. Participants must provide written informed consent prior to enrollment; 4. Participants must be 18 to 50 years of age at the time of enrollment; 5. Participants must have had a live childbirth \<=3 months prior to their enrollment into the study; 6. Participants who have a score of greater than or equal to 13 but not exceeding 19 on the Edinburgh Postnatal Depression Scale (EPDS) during initial screening visit/call; 7. Depression diagnosis needs to be confirmed by licensed behavioral health therapist or medical professional; 8. Participants must answer 0/Never or 1/Hardly Ever to the self-harm question on EPDS (Question #10); 9. Participants must be willing to use a mobile app and own an iOS or android enabled mobile phone or device; 10. Participants must have wireless internet connectivity in their home (or have access to internet connectivity) and be willing to connect devices via a Wi-Fi network
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EPDS Score | 9 week period | Proportion of women that improve EPDS by \>= 4 points at their end of study assessment. |
| EPDS Score improvement | 9 week period | Proportion of women that improve EPDS to \< 13 points at their end of study assessment |
Countries
United States
Outcome results
None listed