Recruiting

Mobile Application

Sponsor:

Curio Digital Therapeutics, Inc.

Code:

NCT05077644

Conditions

Post-partum Depression

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Stella (TM) Mobile Application

Study Details

Brief 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.

Conditions

Post-partum Depression

Study ID

NCT05077644

Start date

Oct 1, 2021

Status verified date

Oct, 2021

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

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

Study Design

Enrollment

65 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Participants who use Stella App

Participant experience in using the mobile application and EPDS results

Interventions

Stella (TM) Mobile Application

Treatment of mild-to-moderate postpartum depression (PPD) using Cognitive Behavioral Therapy techniques.

Primary outcome measure

  • Change in level of depression as measured by Edinburgh Postpartum Depression (EPDS) [ Time Frame: 8 week period ]

Central Contacts and Locations

Central contacts

Locations

HITLAB

Recruiting

New York, New York, United States, 10014

Contacts

More Information

Sponsor

Curio Digital Therapeutics, Inc.

Last update posted

Oct 14, 2021

Last verified

Oct, 2021

Keywords

  • post-partum depression, depression, anxiety, PPD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Curio Digital Therapeutics, Inc. on 2021-10-14.