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

Last updated: October 1, 2021
Sponsor: Curio Digital Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Post-partum Depression

Treatment

N/A

Clinical Study ID

NCT05077644
CU-T-002
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants residing in the states of New York, New Jersey or Connecticut and must beable to read, write, and speak English, and provide written informed consent prior toenrollment
  2. Participants must be between 18 and 50 years of age
  3. Participants must have given live birth within the 4 months prior to the start ofstudy
  4. Participants diagnosed with mild to moderate postpartum depression (as assessed by aclinician upon enrollment) and have scored between 9 and 21 on the Edinburgh PostnatalDepression Scale (EPDS) during screening
  5. Participants must answer "0/Never" or "1/Hardly Ever" to the self-harm question onEPDS (Question #10)
  6. Participants must be willing to use a mobile app and own an iOS enabled mobile phone
  7. Participants must have wireless internet connectivity in the home and be willing toconnect devices to their home Wi-Fi network.

Exclusion

Exclusion Criteria:

  1. Participants who do not reside in the states of New York, New Jersey or Connecticut
  2. Participants who are not able to read, write, and speak English, and provide writteninformed consent prior to enrollment
  3. Participants less than 18 and more than 50 years of age
  4. Participants who have not given birth within the 4 months prior to the start of studyOR did not have a live birth in the last 4 months
  5. Participants who have not been diagnosed with postpartum depression upon clinicalassessment OR do not have a score of between 9 and 21 on the EPDS
  6. Participants with a positive (2 or 3) answer on the EPDS self-harm question (Question

#10) 7. Participants with Serious Mental Illnesses (SMIs), severe depression, or cognitiveimpairments

Study Design

Total Participants: 65
Study Start date:
October 01, 2021
Estimated Completion Date:
December 31, 2021

Study 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).

Connect with a study center

  • HITLAB

    New York, New York 10014
    United States

    Active - Recruiting

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