Curio Digital Therapy for the Treatment of Post-partum Depression

PostPartum Depression Clinical Trial

— SuMMER  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05958095
• Other study ID #: CU-T-003
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: August 15, 2023

Study information

• Verified date: July 2023
• Source: Healthcare Innovation Technology Lab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 142
• Est. completion date: August 15, 2023
• Est. primary completion date: May 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• PostPartum Depression

Intervention

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.
• Digital Sham App
The digital sham app delivers content, tips, and suggestion for general wellbeing support.

Locations

Country	Name	City	State
United States	Healthcare Innovation and Technology Lab	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Healthcare Innovation Technology Lab	Curio Digital Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EPDS Score	Proportion of women that improve EPDS by >= 4 points at their end of study assessment.	9 week period
Primary	EPDS Score improvement	Proportion of women that improve EPDS to < 13 points at their end of study assessment	9 week period