Curio Digital Therapy for the Treatment of Post-partum Depression

Last updated: July 14, 2023
Sponsor: Healthcare Innovation Technology Lab
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Depression (Adult And Geriatric)

Depression (Major/severe)

Depression

Treatment

Digital Sham App

MamaLift Plus

Clinical Study ID

NCT05958095
CU-T-003
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must be able to read, write and speak English; 3. Participants mustprovide written informed consent prior to enrollment; 4. Participants must be 18 to 50years of age at the time of enrollment; 5. Participants must have had a livechildbirth <=3 months prior to their enrollment into the study; 6. Participants whohave a score of greater than or equal to 13 but not exceeding 19 on the EdinburghPostnatal Depression Scale (EPDS) during initial screening visit/call; 7. Depressiondiagnosis needs to be confirmed by licensed behavioral health therapist or medicalprofessional; 8. Participants must answer "0/Never" or "1/Hardly Ever" to theself-harm question on EPDS (Question #10); 9. Participants must be willing to use amobile app and own an iOS or android enabled mobile phone or device; 10. Participantsmust have wireless internet connectivity in their home (or have access to internetconnectivity) and be willing to connect devices via a Wi-Fi network

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 142
Treatment Group(s): 2
Primary Treatment: Digital Sham App
Phase:
Study Start date:
April 01, 2023
Estimated Completion Date:
August 15, 2023

Study 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.

Connect with a study center

  • Healthcare Innovation and Technology Lab

    New York, New York 10032
    United States

    Site Not Available

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