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

Post-partum Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05077644
• Other study ID #: CU-T-002
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2021
• Source: Curio Digital Therapeutics, Inc.
• Contact: Eliza Ng, MPH, MD
• Phone: 1-800-762-9854
• Email: Eliza[@]Curiodigitaltx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Post-partum Depression

Intervention

Device:
• Stella (TM) Mobile Application
Treatment of mild-to-moderate postpartum depression (PPD) using Cognitive Behavioral Therapy techniques.

Locations

Country	Name	City	State
United States	HITLAB	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Curio Digital Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in level of depression as measured by Edinburgh Postpartum Depression (EPDS)	Evaluation of difference in mean change in EDPS at week 8 from baseline assessment. EPDS evaluated every 2 weeks from baseline to week 8	8 week period
Secondary	Proportion of women who reported App use for daily mood, sleep and activities of daily living	Summary reported of daily mood, hours of sleep and activities of daily living as identified through the mobile application	8 week period