NCT05077644

Mobile Application in the Management of Mild to Moderate Postpartum Depression (PPD)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Curio Digital Therapeutics, Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: Evaluate the user experience with the Stella (TM) app for the management of Postpartum Depression in an observed population for 8 calendar weeks.

Detailed description

Women between 18 and 50 years of age who have had a live birth within 4 months prior to study start date and have a diagnosis of mild to moderate PPD. A total of 65 women residing in the state of New York, New Jersey and Connecticut will be recruited to participate in the study. Patient reported outcomes of mild to moderate depression (using EPDS) will be verified by a behavioral health therapist using the Hamilton Depression Rating Scale (HAM-D).

Conditions

• Post-partum Depression

Interventions

Type	Name	Description
DEVICE	Stella (TM) Mobile Application	Treatment of mild-to-moderate postpartum depression (PPD) using Cognitive Behavioral Therapy techniques.

Timeline

• Start date: 2021-10-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-10-14
• Last updated: 2021-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study