NCT05958095

Curio Digital Therapy for the Treatment of Post-partum Depression

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Healthcare Innovation Technology Lab · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• PostPartum Depression

Interventions

Type	Name	Description
DEVICE	MamaLift 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.
DEVICE	Digital Sham App	The digital sham app delivers content, tips, and suggestion for general wellbeing support.

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-05-24
• Completion: 2023-08-15
• First posted: 2023-07-24
• Last updated: 2023-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study