UnknownNot Applicable

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

United States65 participantsStarted 2021-10-01

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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Inclusion criteria

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

Exclusion criteria

✕. Participants who do not reside in the states of New York, New Jersey or Connecticut
✕. Participants who are not able to read, write, and speak English, and provide written informed consent prior to enrollment
✕. Participants less than 18 and more than 50 years of age
✕. Participants who have not given birth within the 4 months prior to the start of study OR did not have a live birth in the last 4 months
✕. Participants who have not been diagnosed with postpartum depression upon clinical assessment OR do not have a score of between 9 and 21 on the EPDS
✕. Participants with a positive (2 or 3) answer on the EPDS self-harm question (Question #10)
✕. Participants with Serious Mental Illnesses (SMIs), severe depression, or cognitive impairments

What they're measuring

Change in level of depression as measured by Edinburgh Postpartum Depression (EPDS)

Timeframe: 8 week period

Trial details

NCT IDNCT05077644

SponsorCurio Digital Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-31

Contact for this trial

Eliza Ng, MPH, MD

1-800-762-9854 Eliza@Curiodigitaltx.com

View on ClinicalTrials.gov More Post-partum Depression trials