Loading clinical trials...

Curio Digital Therapy for the Treatment of Post-partum Depression | Clinical Trials | Clareo Health

UNKNOWNNA

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

NCT05958095•Healthcare Innovation Technology Lab

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 50 years

Sex

FEMALE

Healthy Volunteers

Yes

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

•\-

Locations (1)

Healthcare Innovation and Technology Lab

New York, New York, United States

Key Dates

Start Date

April 1, 2023

Primary Completion Date

May 24, 2023

Completion Date

August 15, 2023

Last Updated

July 24, 2023

Enrollment

142

ACTUAL participants

Conditions

PostPartum Depression

Interventions

MamaLift Plus

DEVICE

Digital Sham App

DEVICE

The Mom and Infant Outcomes (MOMI) Study

NCT06277661

Postpartum DepressionPostpartum Anxiety+1 more

View study

RECRUITING

Clinical Validation of a Predictive Test for Postpartum Depression

NCT06831968

Postpartum Depression (PPD)Pregnancy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Curio Digital Therapy for the Treatment of Post-partum Depression

Inclusion Criteria

Exclusion Criteria

The Mom and Infant Outcomes (MOMI) Study

Clinical Validation of a Predictive Test for Postpartum Depression

Engage & Connect: A Psychotherapy for Postpartum Depression

Maternal Stress on Human Milk and Infant Outcomes

Improving Maternal Sleep and Mental Health

Preventing Postpartum Depression in Immigrant Latinas