Mobile Application in the Management of Mild to Moderate Postpartum Depression (PPD)
Primary Purpose
Post-partum Depression
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stella (TM) Mobile Application
Sponsored by
About this trial
This is an interventional treatment trial for Post-partum Depression focused on measuring post-partum depression, depression, anxiety, PPD
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- HITLABRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Participants who use Stella App
Arm Description
Participant experience in using the mobile application and EPDS results
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05077644
First Posted
October 1, 2021
Last Updated
October 1, 2021
Sponsor
Curio Digital Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05077644
Brief Title
Mobile Application in the Management of Mild to Moderate Postpartum Depression (PPD)
Official Title
Mobile Application in the Management of Mild to Moderate Postpartum Depression (PPD)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Curio Digital Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-partum Depression
Keywords
post-partum depression, depression, anxiety, PPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants who use Stella App
Arm Type
Other
Arm Description
Participant experience in using the mobile application and EPDS results
Intervention Type
Device
Intervention Name(s)
Stella (TM) Mobile Application
Intervention Description
Treatment of mild-to-moderate postpartum depression (PPD) using Cognitive Behavioral Therapy techniques.
Primary Outcome Measure Information:
Title
Change in level of depression as measured by Edinburgh Postpartum Depression (EPDS)
Description
Evaluation of difference in mean change in EDPS at week 8 from baseline assessment. EPDS evaluated every 2 weeks from baseline to week 8
Time Frame
8 week period
Secondary Outcome Measure Information:
Title
Proportion of women who reported App use for daily mood, sleep and activities of daily living
Description
Summary reported of daily mood, hours of sleep and activities of daily living as identified through the mobile application
Time Frame
8 week period
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Adult females who delivered live births in the 4 months prior to study start and reported depressive symptoms after child birth
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eliza Ng, MPH, MD
Phone
1-800-762-9854
Email
Eliza@Curiodigitaltx.com
First Name & Middle Initial & Last Name or Official Title & Degree
Melva Covington, MPH, PhD
Phone
1-800-762-9854
Email
Melva@Curiodigitaltx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stan Kachnowski, MPA, PhD
Organizational Affiliation
Healthcare Innovation Technology Lab
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah Chokshi, DrPH
Organizational Affiliation
Healthcare Innovation Technology Lab
Official's Role
Study Director
Facility Information:
Facility Name
HITLAB
City
New York
State/Province
New York
ZIP/Postal Code
10014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kat Marriott, PhD
Phone
929-502-7147
Email
kmarriott@hitlab.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mobile Application in the Management of Mild to Moderate Postpartum Depression (PPD)
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