Curio Digital Therapy for the Treatment of Post-partum Depression (SuMMER)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: PostPartum Depression
• Intervention / Treatment: Device: MamaLift Plus; Device: Digital Sham App

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.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Healthcare Innovation and Technology Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Healthcare Innovation Technology Lab
• Collaborators: Curio Digital Therapeutics, Inc.
• Investigators: Principal Investigator: Stan Kachnowski, PhD, Healthcare Innovation Technology Lab

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): May 24, 2023
• Study Completion (Estimated): August 15, 2023

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Estimated): July 24, 2023

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: PostPartum depression (PPD), symptoms of PPD, Anxiety, Peri-natal depression, mild-to-moderate depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: CU-T-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes