Curio Digital Therapy for the Treatment of Post-partum Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Supporting Maternal Mental Health and Emotional Regulation (SuMMER): Assessment of the Clinical Effectiveness of a Mobile Application for Patients With Postpartum Depression

Conditions
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PostPartum Depression

Intervention / Treatment
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* Device: MamaLift Plus
* Device: Digital Sham App


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MamaLift Plus<br>Principles of Cognitive Behavioral Therapy used to treat PPD with App | Device: MamaLift Plus<br>* 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.<br>|
| Sham Comparator: Digital Sham App<br>Content on general mental health and wellbeing topics delivered with sham App | Device: Digital Sham App<br>* The digital sham app delivers content, tips, and suggestion for general wellbeing support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PostPartum depression (PPD), symptoms of PPD, Anxiety, Peri-natal depression, mild-to-moderate depression