MedDataX Logo

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

NCT ID: NCT05077644

Last Updated: 2021-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-partum Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participants who use Stella App

Participant experience in using the mobile application and EPDS results

Group Type OTHER

Stella (TM) Mobile Application

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stella (TM) Mobile Application

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Curio Digital Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stan Kachnowski, MPA, PhD

Role: PRINCIPAL_INVESTIGATOR

Healthcare Innovation Technology Lab

Sarah Chokshi, DrPH

Role: STUDY_DIRECTOR

Healthcare Innovation Technology Lab

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

HITLAB

New York, New York, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Eliza Ng, MPH, MD

Role: CONTACT

[email protected]
1-800-762-9854

Melva Covington, MPH, PhD

Role: CONTACT

[email protected]
1-800-762-9854

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kat Marriott, PhD

Role: primary

[email protected]
929-502-7147

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CU-T-002

Identifier Type: -

Identifier Source: org_study_id