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

Curio Digital Therapeutics

Status: Unknown

Conditions: Post-partum Depression

Treatments: Device: Stella (TM) Mobile Application

Study type: Interventional

Funder types: Industry

Identifiers

NCT05077644

CU-T-002

Details and patient eligibility

About

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.

Full 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).

Enrollment: 65 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Participants who use Stella App

Other group

Description:

Participant experience in using the mobile application and EPDS results

Treatment:

Device: Stella (TM) Mobile Application