New York, New York 10014

  • partum Depression

Purpose:

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.


Study summary:

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).


Criteria:

Inclusion Criteria: 1. 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 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 of study 4. 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 5. Participants must answer "0/Never" or "1/Hardly Ever" to the self-harm question on EPDS (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 to connect devices to their home Wi-Fi network. 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 written informed 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 study OR did not have a live birth in the last 4 months 5. 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 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 cognitive impairments


NCT ID:

NCT05077644


Primary Contact:

Principal Investigator
Stan Kachnowski, MPA, PhD
Healthcare Innovation Technology Lab

Eliza Ng, MPH, MD
Phone: 1-800-762-9854
Email: Eliza@Curiodigitaltx.com


Backup Contact:

Email: Melva@Curiodigitaltx.com
Melva Covington, MPH, PhD
Phone: 1-800-762-9854


Location Contact:

New York, New York 10014
United States

Kat Marriott, PhD
Phone: 929-502-7147
Email: kmarriott@hitlab.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: July 01, 2022

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