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

NCT05077644 | Unknown FDA Device

• 1 other identifier: CU-T-002
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Keywords

post-partum depression, depression, anxiety, PPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of women who reported App use for daily mood, sleep and activities of daily living

  8 week period

Study Arms (1)

Participants who use Stella App

OTHER

Participant experience in using the mobile application and EPDS results

Device: Stella (TM) Mobile Application

Interventions

Stella (TM) Mobile Application DEVICE

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

Participants who use Stella App

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Adult females who delivered live births in the 4 months prior to study start and reported depressive symptoms after child birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Curio Digital Therapeutics, Inc.: lead

Study Sites (1)

HITLAB

New York, New York, 10014, United States

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Stan Kachnowski, MPA, PhD

  Healthcare Innovation Technology Lab

  PRINCIPAL INVESTIGATOR

• Sarah Chokshi, DrPH

  Healthcare Innovation Technology Lab

  STUDY DIRECTOR

Central Study Contacts

Eliza Ng, MPH, MD

CONTACT

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

Melva Covington, MPH, PhD

CONTACT

1-800-762-9854; Melva@Curiodigitaltx.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Data from 65 participants (n=50 in this extended study of a piloted user study) will be collected and analyzed to assess the user experience of the Stella (TM) App. Participants will be selected if they have given birth in the four months prior to the study start date, meet eligibility criteria and and have mild-to moderate postpartum depression or have experienced depressive

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 14, 2021
• Study Start: October 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)